2052 INDEX Pharmacopeial Forum Vol. 28(6) [Nov.-Dec. 2002

2052

INDEX

Pharmacopeial Forum

Vol. 28(6) [Nov.-Dec. 2002]

[Note—This index covers

Vol.

No.

pp.

1-193,

Vol.

28,

No. 2

pp.

195-691,

Vol.

28, No.

pp.

693-1016,

Vol.

28, No. 4

pp.

1017-

1340,

Vol.

28, No.

pp.

1341-1707,

Vol.

28, No.

6pp.

1709-2060]

GENERAL NOTICES AND REQUIREMENTS (USP)

"Official"

and

"Official Articles"—USP

32, 733, 1059, 1757

Ingredients

and

Processes—USP

1060

Preservation, Packaging, Storage,

and

Labeling—

USP

242,

1061,

1383

Significant Figures

and

Tolerances—USP

1379

Tests

and

Assays—USP

1042, 1380

Weights

and

Measures—USP

717

GENERAL NOTICES AND REQUIREMENTS (NF)

"Official" and "Official Articles"—NF

MONOGRAPHS

Acebutolol Hydrochloride (USP)

: 1063

Acebutolol Hydrochloride Capsules (USP)

Acetaminophen

and

Caffeine Tablets (USP)

1064

Tablets Containing

Least Three of the Following Acetaminophen

and Salts

Chlorpheniramine, Dextromethorphan,

and

Pseudoephedrine (USP)

1065

Medical

Air

(USP)

1065

Alendronate Sodium (USP)

737

Alendronate Sodium Tablets (USP)

33, 740

Alfadex (NF)

1611

Alfentanil Hydrochloride (USP)

244

Allopurinol Oral Solution (USP)

1386, 1991

Alprostadil (USP)

245

Alprostadil Injection (USP)

1389

Amantadine Hydrochloride Oral Solution (USP)

250

Amantadine Hydrochloride Syrup (USP)

251

Amikacin (USP)

1065

Amiloride Hydrochloride

and

Hydrochlorothiazide

Tablets (USP)

1066, 1740

Aminobenzoate Sodium (NF)

1207

Aminocaproic Acid Oral Solution (USP)

251

Aminocaproic Acid Syrup (USP)

252

Amiodarone Hydrochloride (USP)

923

Amiodarone Hydrochloride Tablets (USP)

925

Ammonio Methacrylate Copolymer Dispersion (NF)

628

Amoxicillin Capsules (USP)

Amoxicillin Tablets (USP)

Amoxicillin Tablets

for

Oral Suspension (USP)

1067

Amoxicillin

and

Clavulanate Potassium

for

Oral

Suspension (USP)

36, 1390

Amoxicillin

and

Clavulanate Potassium Tablets

(USP)

Amphetamine Sulfate (USP)

744

Ampicillin (USP)

1766

Ampicillin Capsules (USP)

1766

Ampicillin

for

Injectable Suspension (USP)

1766

Ampicillin Tablets (USP)

1767

Antirabies Serum (USP)

1068

Antivenin (Crotalidae) Polyvalent (USP)

1068

Aspartame Acesulfame (NF)

1613

Aspartic Acid (USP)

252, 1391

Astemizole Tablets (USP)

745

Atenolol Oral Solution (USP)

1991

Atenolol Tablets (USP)

Bacitracin (USP)

745, 1069

Bacitracin

for

Injection (USP)

1069

Bacitracin Ointment (USP)

1070

Bacitracin Ophthalmic Ointment (USP)

1070

Bacitracin

and

Polymyxin

Sulfate Topical Aerosol (USP)

... 1070

Bacitracin Zinc (USP)

1070

Bacitracin Zinc Ointment (USP)

1071

Bacitracin Zinc

and

Polymyxin

Sulfate Ointment (USP)

.... 1071

Bacitracin Zinc

and

Polymyxin

Sulfate Ophthalmic Ointment

(USP)

1071

Barium Sulfate (USP)

Barium Sulfate Suspension (USP)

Barium Sulfate

for

Suspension (USP)

Benzethonium Chloride Concentrate (USP)

745

Benazepril Hydrochloride (USP)

1768

Benazepril Hydrochloride Tablets (USP)

Benzethonium Chloride Concentrate (USP)

Benztropine Mesylate Tablets (USP)

1392

Benzyl Alcohol (NF)

879

Benzylpenicilloyl Polylysine Concentrate (USP)

42, 46

Betamethasone (USP)

1772

Betamethasone Cream (USP)

1773

Betamethasone Acetate (USP)

1773

Betamethasone Oral Solution (USP)

253

Betamethasone Syrup (USP)

254

Bethanechol Chloride Injection (USP)

1072

Bethanechol Chloride Tablets (USP)

1773

Leukocyte Typing Serum (USP)

1072

Blood Group Specific Substances

A, B, and

AB (USP)

1073

Bismuth Subsalicylate Magma (USP)

Bismuth Subsalicylate Oral Suspension (USP)

627

Bismuth Subsalicylate Tablets (USP)

133, 1603

Brinzolamide Ophthalmic Suspension (USP)

1774

Bromodiphenhydramine Hydrochloride Elixir (USP)

.... 254, 1776

Bromodiphenhydramine Hydrochloride Oral Solution

(USP)

255, 1777

Brompheniramine Maleate Elixir (USP)

255

Brompheniramine Maleate Oral Solution (USP)

256

Brompheniramine Maleate

and

Pseudoephedrine Sulfate

Oral Solution (USP)

256

Brompheniramine Maleate and Pseudoephedrine Sulfate

Syrup (USP)

258

Bupropion Hydrochloride Extended-Release Tablets (USP)

... 1074

Butabarbital Sodium (USP)

717

Butabarbital Sodium Elixir (USP)

259

Butabarbital Sodium Oral Solution (USP)

259

Butorphanol Tartrate (USP)

1080

Butylparaben (NF)

572

Caffeine Injection (USP)

1992

Caffeine Oral Solution (USP)

1994

Calcium Carbonate Lozenges (USP)

1778

Calcium Carbonate Tablets (USP)

1392

Calcium Polycarbophil (USP)

260

Candelilla Wax

(NF) 1275

Captopril

and

Hydrochlorothiazide Tablets (USP)

1080, 1740

Caprylcaproyl Macrogolglycerides

(NF) 1208

Carbamazepine Extended-Release Tablets (USP)

746

Carbidopa (USP)

1081

Carbidopa

and

Levodopa Tablets (USP)

747

Carbomer Homopolymer (NF)

1276

Carbon Dioxide (USP)

1082

Urea C13 (USP)

1083

Carboxymethylcellulose Calcium (NF)

1252

Carboxymethylcellulose Sodium (NF)

867

Carboxymethylcellulose Sodium, Low-substituted (NF)

1617

Cefaclor (USP)

1084

Cefaclor Capsules (USP)

1087

Cefaclor

for

Oral Suspension (USP)

1087

Cefaclor Extended-Release Tablets (USP)

1088, 1245

Cefazolin Ophthalmic Solution (USP)

261

Cefipime

for

Injection

1778

Cefpiramide (USP)

747

Cefpodoxime Proxetil (USP)

Cefpodoxime Proxetil

for

Oral Suspension (USP) ........

Cefpodoxime Proxetil Tablets (USP)

Cefuroxime Axetil

for

Oral Suspension (USP)

1780

Cellacefate (NF)

1253

Cellulose Acetate (NF)

1255

Microcrystalline Cellulose (NF)

720, 1893

Cephalexin Tablets

for

Oral Suspension (USP)

1782

Cetostearyl Alcohol (NF)

1211

Rights

Reserved.

Pharmacopeial Forum

Vol.

28(6) [Nov.-Dec. 2002]

INDEX 2053

Chaste Tree (NF) 139

Powdered Chaste Tree (NF) 142

Horse Chestnut (NF) 797

Powdered Horse Chestnut (NF) 799

Powdered Horse Chestnut Extract (NF) 800

Chloral Hydrate Oral Solution (USP) 261

Chloral Hydrate Syrup (USP) 262

Chlorothiazide (USP) 1089, 1741

Chlorothiazide Sodium for Injection (USP) 51

Chlorpheniramine Maleate Oral Solution (USP) 262

Chlorpheniramine Maleate Syrup (USP) 263

Black Cohosh (NF) 1455

Powdered Black Cohosh (NF) 1460

Powdered Black Cohosh Extract (NF) 1461

Black Cohosh Tablets (NF) 1462

Cholera Vaccine (USP) 1090

Cholestyramine for Oral Suspension (USP) 51

Chondroitin Sulfate Sodium (Nf) 801

Chondroitin Sulfate Tablets (NF) 804

Sodium Chromate Cr

Injection (USP) 264

Ciclopirox Olamine (USP) 265

Cimetidine Tablets (USP) 52

Ciprofloxacin (USP) 1090

Citric Acid (USP) 872

Citric Acid, Anhydrous (USP) 872

Citric Acid, Monohydrate (USP) 876

Clavulanate Potassium (USP) 1393

Clindamycin Hydrochloride Capsules (USP) . 1090

Clindamycin Phosphate Topical Solution (USP) 1393

Clomipramine Hydrochloride Capsules (USP) 52

Clonazepam Tablets (USP) 54

Clonidine (USP) 1263

Clonidine Transdermal System (USP) 265

Clorazepate Dipotassium Tablets (USP) 54

Clorsulon (USP) 55, 269

Red Clover (NF) 807

Powdered Red Clover (NF) 810

Powdered Red Clover Extract (NF) 811

Red Clover Tablets (NF) 812

Cloxacillin Sodium (USP) 1091

Cloxacillin Sodium Capsules (USP) 1092

Cloxacillin Sodium for Oral Solution (USP) 1092

Cocaine and Tetracaine Hydrochlorides and Epinephrine

Topical Solution (USP) 270

Colistin Sulfate (USP) 1093

Crospovidone(NF) 948, 1257

Coriander Oil (NF) 629, 1464

Corn Syrup (NF) 403

High Fructose Corn Syrup (NF) 408

Corn Syrup Solids (NF) 630, 1894

Corticotropin Injection (USP) 1783

Corticotropin for Injection (USP) 1784

Hydrogenated Cottonseed Oil (NF) 1280

Cromolyn Sodium Nasal Solution (USP) 1093

Cromolyn Sodium Ophthalmic Solution (USP) 1094

Croscarmellose Sodium (NF) 1567

Crospovidone (NF) 1057

Cupric Sulfate (USP) 717

Cyanocobalamin Co 58 Capsules (USP) 748

Cycloserine Capsules (USP) 750

Cyproheptadine Hydrochloride Oral Solution (USP) 271

Cyproheptadine Hydrochloride Syrup (USP) 272

Dacarbazine for Injection (USP) 1784

Desogestrel (USP) 1785

Desogestrel and Ethinyl Estradiol Tablets (USP) 1094, 1394

Dexamethasone Injection (USP) 1402

Dexchlorpheniramine Maleate Oral Solution (USP) 272

Dexchlorpheniramine Maleate Syrup (USP) 273

Dexchlorpheniramine Maleate Tablets (USP) 273

Dextran

(USP) 1787

Dextran 70 (USP) 717

Dextrin (NF) 411

Dextroamphetamine Sulfate (USP) 751

Dextroamphetamine Sulfate Elixir (USP) 274

Dextroamphetamine Sulfate Oral Solution (USP) 274

Dextroamphetamine Sulfate Tablets (USP) 276

Dextromethorphan Hydrobromide Oral Solution

(USP) 276

Dextromethorphan Hydrobromide Syrup (USP) 277

Dibutyl Phthalate (NF) 1619

Dicyclomine Hydrochloride Capsules (USP) 1042, 1402

Dicyclomine Hydrochloride Oral Solution (USP) 278

Dicyclomine Hydrochloride Syrup (USP) 279

Diethylcarbamazine Citrate (USP) 1098

Diethylcarbamazine Citrate Tablets (USP) 1099

Diethylene Glycol Monostearate (NF) 1621

Digoxin Elixir (USP) 279

Digoxin Injection (USP) 279

Digoxin Oral Solution (USP) 279

Digoxin Tablets (USP) 55, 281

Diltiazem Hydrochloride Extended-Release Capsules

(USP) 1099, 1741

Dimenhydrinate Injection (USP) 717, 752

DimenhydrinateOral Solution (USP) 281, 753

Dimenhydrinate Syrup (USP) 282, 755

Dimenhydrinate Tablets (USP) 717, 756

Dimethicone (USP) 720, 813

Dinoprost Tromethamine (USP) 1102

Dinoprostone (USP) 56

Diphenhydramine Hydrochloride Elixir (USP) 282

Diphenhydramine Hydrochloride Oral Solution (USP) 283

Diphtheria Antitoxin (USP) 1102

Diphtheria Toxoid (USP) 1103

Diphtheria Toxoid Adsorbed (USP) 1103

Diphtheria and Tetanus Toxoids (USP) 1103

Diphtheria and Tetanus Toxoids and Pertussis Vaccine (USP) . . 1104

Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed

(USP) 1104

Dipivefrin Hydrochloride (USP) 1105

Dipyridamole Injection (USP) 1105

Dipyridamole Tablets (USP) 1402

Divalproex Sodium Delayed-Release Tablets (USP) 284

Dobutamine in Dextrose Injection (USP) 1403

Dorzolamide Hydrochloride (USP) 1107

Doxazosin Mesylate (USP) 286, 1403

Doxazosin Mesylate Tablets (USP) 289

Doxylamine Succinate Oral Solution (USP) . 291

Doxylamine Succinate Syrup (USP) \ . . . 292

Dyphylline Elixir (USP) 292

Dyphylline Oral Solution (USP) 292

Dyphylline and Guaifenesin Elixir (USP) 293

Dyphylline and Guaifenesin Oral Solution (USP) 294

Emedastine Difumarate (USP) 1110

Enalapril Maleate Tablets (USP) 295, 1110

Ephedrine Sulfate Oral Solution (USP) 296

Ephedrine Sulfate Syrup (USP) 297

Epinephrine Inhalation Solution (USP) 1111, 1744

Ergoloid Mesylates Tablets (USP) 59

Erythromycin Ethylsuccinate Tablets (USP) 1112

Erythromycin Ointment (USP) 297

Ethambutol Hydrochloride Tablets (USP) 1406

Ethinyl Estradiol Tablets (USP) 1112

Ethosuximide Capsules (USP) 1116

Ethosuximide Oral Solution (USP) 1407

Ethylcellulose (NF) 1568

Ethylene Glycol Monostearate (NF) 1622

Ethylenediamine (USP) 1789

Ethylparaben (NF) 574

Etodolac Extended-Release Tablets (USP) 1996

Etoposide (USP) 1407

Felodipine Extended-Release Tablets (USP) 1116

Fenoldopam Mesylate (USP) 1120

2002

The United States Pharmacopeial Convention, Inc.

All Rights

Reserved.

2054

INDEX

Pharmacopeial Forum

Vol. 28(6) [Nov.-Dec. 2002]

Ferric Oxide (NF) 720

Ferrous Gluconate Elixir (USP) 297

Ferrous Gluconate Oral Solution (USP) 297

Ferric Subsulfate Solution (USP) 1789

Ferric Sulfate (USP) 1408, 1790

Fexofenadine Hydrochloride (USP) 1790

Fexofenadine Hydrochloride Capsules (USP) 1793

Ferumoxides Injection (USP) 758

Fludarabine Phosphate (USP) 1795

Fludarabine Phosphate for Injection (USP) 1799

Fluorodopa F 18 Injection (USP) 762

Fluoxetine Capsules (USP) 1408

Fluoxetine Delayed-Release Capsules (USP) 1265

Fluoxetine Hydrochloride (USP) 1802

Fluoxetine Tablets (USP) 1739, 1803

Fluoxymesterone (USP) 59

Flurbiprofen (USP) 1121

Flurbiprofen Sodium (USP) 762

Furosemide Oral Solution (USP) 59, 727

Gabapentin Capsules (USP) 298

Gadoteridol (USP) 1121

Gadoversetamide (USP) 926

Gadoversetamide Injection (USP) 931

Ganciclovir (USP) 301, 762

Garlic Delayed-Release Tablets (NF) 89

Ginger Capsules (NF) 814

Glucosamine Hydrochloride (NF) 92

Glucosamine Sulfate Potassium Chloride (NF) 94

Glucosamine Sulfate Sodium Chloride (NF) 95

Glucosamine Tablets (NF) 97

Glucosamine and Chondroitin Sulfate Tablets (NF) 98, 1896

Glutaral Concentrate (USP) 60, 762

Glyburide Tablets (USP) 60

Glycerin (USP) 727, 764, 863, 1245

Glyceryl Distearate (NF) 1624

Glyceryl Monolinoleate (NF) 1627

Glyceryl Monooleate (NF) 1629

Gold Sodium Thiomalate (USP) 1121, 1410

Graftskin (USP) 1804

Guaifenesin Oral Solution (USP) 302

Guaifenesin Syrup (USP) 303

Guaifenesin and Codeine Phosphate Oral Solution

(USP) 303

Guaifenesin and Codeine Phosphate Syrup (USP) 306

Helium (USP) 1121

Hydralazine Hydrochloride (USP) 1122

Hydralazine HydrochlorideOral Solution (USP) 306

Hydrochlorothiazide (USP) 60, 1123

Hydrochlorothiazide Tablets (USP) 1124, 1745

Hydrocodone Bitartrate (USP) 63

Hydrocodone Bitartrate and Homatropine Methylbromide Tablets

(USP) 1267

Hydrocortisone (USP) 764

Hydrogen Peroxide Concentrate (USP) 65, 765

Hydrogenated Soybean Oil (NF) 1631

Hydroxypropyl Betadex (NF) 1282

Hydroxyzine Hydrochoride Oral Solution (USP) 307

Hydroxyzine Hydrochoride Syrup (USP) 308

Hydroxyzine Hydrochloride Tablets (USP) 27

Hymetellose (NF) 1633

Hypromellose Acetate Succinate (NF) 1635

Indapamide Tablets (USP) 1410

Indium In 111 Ibritumomab Tiuxetan Injection (USP) 1815

Indocyanine Green (USP) 765

Insulin (USP) 1125

Insulin Human (USP) 65

Insulin Lispro (USP) 66, 1125

Insulin Lispro Injection (USP) 69, 1128

Inulin in Sodium Chloride Injection (USP) 1817

Iodoform (USP) 1817

Iohexol (USP) 70

Iohexol Injection (USP) 308

Iron Sucrose Injection (USP) 1130

Ipecac Oral Solution (USP) 308

Ipecac Syrup (USP) 310

Isoniazid Oral Solution (USP) 310

Isoniazid Syrup (USP) 311

Isoetharine Inhalation Solution (USP) 1134, 1745

Isosorbide Concentrate (USP) 71, 766

Diluted Isosorbide Mononitrate (USP) 933

Isosorbide Mononitrate Tablets (USP) 936

Isosorbide Mononitrate Extended-Release Tablets (USP) .... 939

Isoproterenol Inhalation Solution (USP) 1134, 1746

Isoproterenol Sulfate Inhalation Solution (USP) 1135, 1746

Ivermectin (USP) 1135

Kava (NF) 100

Powdered Kava (NF) 104, 815

Semisolid Kava Extract (NF) 817

Kava Capsules (NF) 818

Kava Tablets (NF) 820

Ketamine Hydrochloride (USP) 1140, 1411

Ketoconazole Oral Suspension (USP) 311

Lactic Acid (USP) 1817

Lactulose Concentrate (USP) 71, 766

Lansoprazole Delayed-Release Capsules (USP) 766

Lauroyl Macrogolglycerides (NF) 1212

Lemon Tincture (NF) 631, 1464

Leuprolide Acetate (USP) 1412

Letrozole Tablets (USP) 71

Levmetamfetamine (USP) 1141

Levothyroxine Sodium Tablets (USP) 312, 727, 1141

Levocarnitine (USP) 71

Levonorgestrel (USP) 1245

Levothyroxine Sodium Tablets (USP) 312, 727, 1141

Lincomycin Hydrochloride Soluble Powder (USP) 73

Lincomycin Hydrochloride Syrup (USP) 313

Lincomycin Oral Solution (USP) 313

Linoleoyl Macrogolglycerides (NF) 1213

Liothyronine Sodium (USP) 1141

oc-Lipoic Acid Capsules (NF) 822

a-Lipoic

Acid Tablets (NF) 824

Lithium Citrate Syrup (USP) 314

Lithium Oral Solution (USP) 314

Loperamide Hydrochloride Oral Solution (USP) 1418

Loratadine (USP) 1604

Loratadine Oral Solution (USP) 1606

Loratadine Tablets (USP) . . . 1608

Lovastatin Tablets (USP) 1142

Lutein (NF) 632

Lutein Preparation (NF) 634

Mafenide Acetate (NF) 769

Magnesium Aluminometasilicate (NF) 411,1214

Magnesium Aluminosilicate (NF) 414,1217

Magnesium Oxide (USP) 1142

Maleic Acid (NF) 2005

Maltitol Solution (NF) 824

Maltose (NF) 951, 1465

Mangafodipir Trisodium (USP) 315

Mangafodipir Trisodium Injection (USP) 1419

Mangafodipir Trisodium Injection (USP) 315

Mannitol Injection (USP) 73

Measles and Mumps Virus Vaccine Live (USP) 1143

Mecamylamine Hydrochloride (USP) 321, 1817

Mecamylamine Hydrochloride Tablets (USP) 322

Meningococcal Polysaccharide Vaccine Group A (USP) 1143

Meningococcal Polysaccharide Vaccine Group C (USP) 1143

Meningococcal Polysaccharide VaccineGroups A and C Combined

(USP) 1144

Meperidine Hydrochloride Oral Solution (USP) 323

Meperidine Hydrochloride Syrup (USP) 323

Mepivacaine Hydrochloride Injection (USP) 1820

Metaproterenol Sulfate Inhalation Solution (USP) 1144, 1746

All Rights

Reserved.

2056

INDEX

Pharmacopeial Forum

Vol. 28(6) [Nov.-Dec. 2002]

Nystatin Lozenges (USP) 135

Nystatin Ointment (USP) 135

Nystatin OralSuspension (USP) 136

Nystatin Tablets (USP) 137

Nystatin Topical Powder (USP) 136

Nystatin and Triamcinolone Acetonide Cream (USP) 137

Nystatin and Triamcinolone Acetonide Ointment

(USP) 138

Octisalate 1420

Octocrylene (USP) 1170

Ofloxacin Ophthalmic Solution (USP) 1170

Oil-

and Water-Soluble Vitamins Tablets (USP) 1544

Oil-

and Water-Soluble Vitamins with Minerals Capsules

(USP) 1544

Oil-

and Water-Soluble Vitamins with Minerals Tablets

(USP) 1545

Oil-Soluble Vitamins Tablets (USP) 1547

Oleic Acid (NF) 1898

Oleoyl Macrogolglycerides (NF) 1220

Ondansetron Injection (USP) 1835

Compound Orange Spirit (NF) .637, 1466

Oral Solution Vehicle (USP) 1998

Oral Solution Vehicle Sugar Free (USP) 1998

Oral Suspension Vehicle (USP) 1999

Oxandrolone (USP) 1835

Oxaprozin (USP) 942

Qxaprozin Tablets (USP) 944

Oxybutynin Chloride Oral Solution (USP) . 334

Oxybutynin Chloride Syrup (USP) 336

Oxycodone Hydrochloride (USP) 84

Oxycodone and Acetaminophen Capsules (USP) 27

Oxygen (USP) 1171

Oxygen 93 Percent (USP) 1171

Paclitaxel (USP) 336, 1421

Paclitaxel Injection (USP) 1172

Paromomycin Oral Solution (USP) 341

Paromomycin Sulfate Syrup (USP) 342

Paroxetine Hydrochloride (USP) 1425

Paroxetine Tablets (USP) 777, 1174

Penicillin G Benzathine and Penicillin G Procaine Injectable

Suspension (USP) 1176

Penicillin G Procaine Injectable Suspension (USP) 1176

Pentazocine Injection (USP) 1836

Pentazocine Hydrochloride and Acetaminophen Tablets

(USP) 945, 1838

Pentazocine and Aspirin Tablets (USP) 1841

Pentazocine and Naloxone Tablets (USP) 1844

Pentazocine and Naloxone Hydrochlorides Tablets

(USP) 84, 1846

Pentazocine Hydrochloride and Aspirin Tablets (USP) 1847

Pentazocine Lactate Injection (USP) 1847

Pentobarbital Elixir (USP) 342

Pentobarbital Oral Solution (USP) 342

Pentoxifylline Extended-Release Tablets (USP) 1177, 1433

Pertussis Vaccine (USP) 1181

Pertussis Vaccine Adsorbed (USP) 1182

Perflutren Protein-Type A Microspheres for Injection

(USP) 1440, 1852

Perflutren Protein-Type A Microspheres Injectable Suspension

(USP) 1848

Petrolatum (USP) 570

White Petrolatum (USP) 570

Phenobarbital Elixir (USP) 343

Phenobarbital Oral Solution (USP) 344

Phenolsulfonphthalein (NF) 1899

2-Phenoxyethanol (NF) 1900

Phenylbutazone (USP) 1440

Phenylpropanolamine Hydrochloride Extended-Release

Capsules (USP) 863

Phenylpropanolamine Hydrochloride Extended-Release Tablets

(USP) 863

Extended Phenytoin Sodium Capsules (USP) 780, 1373

Phytonadione Injectable Emulsion (USP) 1852

Phytonadione Injection (USP) 1853

Maritime Pine (NF) 1903

Maritime Pine Extract (NF) 1905

Piperacillin (USP) 1182

Piperacillin and Tozobactam Injection (USP) 2000

Piperacillin and Tozobactam for Injection (USP) 2001

Plague Vaccine (USP) 1182

Poloxamer (NF) 827

Poliovirus Vaccine Live Oral (USP) 1183

Polydecene (NF) 1284

Polyethylene Glycol (NF) 577, 827, 1908

Polyisobutylene (NF) 1287

Polymyxin B Sulfate (USP) 1183

Polymyxin B for Injection (USP) 1184

Polymyxin B Sulfate and Bacitracin Zinc Topical Aerosol

(USP) 1185

Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution

(USP) 1185

Polyoxyl 40 Stearate (NF) 720

Polyoxyl Lauryl Ether (NF) 1640

Polyoxyl Oleate (NF) 1641

Polyoxyl Stearyl Ether (NF) 1642

Potassium Acetate (USP) 1185

Potassium Chloride Extended-Release Tablets (USP) ... 783,1052

Potassium Gluconate Elixir (USP) 345

Potassium Gluconate Oral Solution (USP) 345

Potassium Nitrate (NF) 717

Povidone (USP) 1733

Praziquantel (USP) 84, 1853

Prazosin Hydrochloride Capsules (USP) 346

Propantheline Bromide (USP) 1186

Prednisolone (USP) 1440

Prednisolone Oral Solution (USP) 346

Prednisolone Syrup (USP) 347

Probenecid Tablets (USP) 347

Procainamide Hydrochloride Tablets (USP) 347

Progesterone Injectable Suspension (USP) 1442

Progesterone Vaginal Suppositories (USP) 348

Promethazine Hydrochloride Oral Solution (USP) 348

Promethazine Hydrochloride Syrup (USP) 349

Propofol (USP) 1854

Propranolol Hydrochloride (USP) 1186

Propranolol Hydrochloride and Hydrochlorothiazide Extended-

Release Capsules (USP) 1747

Propranolol Hydrochloride and Hydrochlorothiazide Tablets

(USP) 1188, 1748

Propofol (USP) 784

Propoxyphene Hydrochloride (USP) 350, 1443, 1857

Propoxyphene Napsylate (USP) 352, 1859

Propylparaben (USP) 581

Protamine Sulfate (USP) 1862

Pseudoephedrine Hydrochloride Oral Solution (USP) 354

Pseudoephedrine Hydrochloride Syrup (USP) 355

Pseudoephedrine Hydrochloride Tablets (USP) 356

Pseudoephedrine Hydrochloride Extended-Release

Tablets (USP) 85

Pyridostigmine Bromide Oral Solution (USP) 356

Pyridostigmine Bromide Syrup (USP) 357

Quinidine Gluconate Extended-Release Tablets (USP) 717

Racepinephrine Inhalation Solution (USP) 1190, 1749

Ramipril (USP) 357

Ranitidine Oral Solution (USP) 360

Reserpine Elixir (USP) 362

Reserpine Oral Solution (USP) 362

Reserpine and Hydrochlorothiazide Tablets (USP) 1190, 1749

Reserpine, Hydralazine Hydrochloride, and Hydrochlorothiazide

Tablets (USP) 1190, 1749

Rifampin Oral Suspension (USP) 363

Rifampin and Isoniazid Capsules (USP) 1862

Rights

Reserved.

Pharmacopeial Forum

Vol. 28(6) [Nov.-Dec. 2002]

INDEX

2057

Rifampin, Isoniazid, and Pyrazinamide Tablets (USP) 1865

Saw Palmetto Extract (NF) 425

Scopolamine Hydrobromide (USP) 1868

Secobarbital Elixir (USP) 364

Secobarbital Oral Solution (USP) 364

Selenomethionine (USP) 1192

Senna Oral Solution (USP) 365

Senna Syrup (USP) 365

Sesame Oil (NF) 832

Simethicone (USP) 366

Simvastatin Tablets (USP) 1193

Sodium Bicarbonate (USP) 1445

Sodium Buryrate (USP) 1868

Sodium Chloride (USP) 1249

Sotalol Hydrochloride (USP) 1868

Sodium Hypochlorite Topical Solution (USP) 366

Sodium Sulfide Topical Gel (USP) 366

Tribasic Sodium Phosphate (NF) 1288

Sodium Sulfite (NF) 2007

Sorbitan Sesquioleate (NF) 1733

Sorbitol (NF) 833

Anhydrized Liquid Sorbitol (NF) 953

Sorbitol Solution (NF) 717, 787

Noncrystallizing Sorbitol Solution (NF) 835

Starch (NF) 837

Corn Starch (NF) 882

Modified Starch (NF) 1221

Potato Starch (NF) 885

Pregelatinized Starch (NF) 1290

Pregelatinized Modified Starch (NF) 1222

Tapioca Starch (NF) 838

Wheat Starch (NF) 888

Stanozolol Tablets (USP) 367

Stearic Acid (NF) 583, 839

Purified Stearic Acid (NF) 839

Stearoyl Macrogolglycerides (NF) 1223

Streptomycin Injection (USP) 86

Streptomycin for Injection (USP) 86

Streptomycin Sulfate (USP) 87

Sucralfate (USP) 367

Sucralfate Tablets (USP) 369

Sugar-Free Suspension Structured Vehicle (NF) 428

Sulfadimethoxine (USP) 1871

Sulfadimethoxine Sodium (USP) 1733, 1872

Sulfasalazine Delayed-Release Tablets (USP) 788

Sulisobenzone (USP) 1193

Suspension Structured Vehicle (NF) 429

Talc (NF) 955

Tazobactam Sodium (USP) 2003

Terazosin Hydrochloride (USP) 369

Terpin Hydrate Elixir (USP) 374

Terpin Hydrate Oral Solution (USP) 375

Terpin Hydrate and Codeine Elixir (USP) 375

Terpin Hydrate and Codeine Oral Solution (USP) 376

Tetanus Antitoxin (USP) 1193

Tetanus Toxoid (USP) 1194

Tetracycline Hydrochloride Oral Suspension (USP) 378

Theophylline Sodium Glycinate Elixir (USP) 378

Theophylline Sodium Glycinate Oral Solution (USP) 378

Thiamine Hydrochloride Elixir (USP) 379

Thiamine Hydrochloride Injection (USP) 380

Thiamine Hydrochloride Oral Solution (USP) 380

Thiamine Mononitrate Elixir (USP) 381

Thiamine Mononitrate Oral Solution (USP) 381

Thyroid (USP) 789

Thyroid Tablets (USP) 88

Tiamulin Fumarate (USP) 1872

Timolol Maleate and Hydrochlorothiazide Tablets (USP) . .1194, 1750

Tobramycin Inhalation Solution (USP) 789, 1446

Tolu Balsam Syrup (NF) 637, 1467

Tolu Balsam Tincture (NF) 637, 1468

Torsemide (USP) 382

Triamcinolone Diacetate Oral Solution (USP) 383

Triamcinolone Diacetate Syrup (USP) 384

Triarnterene Capsules (USP) 792

Triamterene and Hydrochlorothiazide Capsules (USP) . . .1195, 1750

Triamterene and Hydrochlorothiazide Tablets

(USP) 717, 794, 1196, 1751

Trichlormethiazide (USP) 1196, 1751

Triazolam (USP) 385

Tricitrates Oral Solution (USP) 385

Trifluoperazine Hydrochloride Syrup (USP) 385

Trifluoperazine Oral Solution (USP) 385

Medium-Chain Triglycerides (NF) 1645

Trihexyphenidyl Hydrochloride Elixir (USP) 386

Trihexyphenidyl Hydrochloride Oral Solution (USP) 387

Trimeprazine Oral Solution (USP) 388

Trimeprazine Tartrate Syrup (USP) 389

Trimethoprim (USP) 389

Triprolidine Hydrochloride Oral Solution (USP) 390

Triprolidine Hydrochloride Syrup (USP) 391

Triprolidine Hydrochloride Tablets (USP) 392

Triprolidine and Pseudoephedrine Hydrochlorides Oral

Solution (USP) 392

Triprolidine and Pseudoephedrine Hydrochlorides Syrup

(USP) 394

Triprolidine and Pseudoephedrine Hydrochlorides

Tablets (USP) 394

Crystallized Trypsin for Inhalation Solution (USP) 794,1374

Typhoid Vaccine (USP) 1197

Urofollitropin (USP) 1875

Urofollitropin for Injection (USP) 1881

Valproic Acid Oral Solution (USP) 395

Valproic Acid Syrup (USP) 396

Valsartan (USP) 396

Valsartan Capsules (USP) 399, 1197

Vecuronium Bromide (USP) 1449, 1886

Verteporfin (USP) 1200

Verteporfin for Injection (USP) 1202

Vitamin E Capsules 1889

Vitamin E Polyethylene Glycol Succinate (NF) 1909

Water for Hemodialysis (USP 1610

Water for Injection (USP) 1204, 1453

Purified Water (USP) 1205

Sterile Purified Water (USP) 1272

Water-Soluble Vitamins with Minerals Capsules (USP) 1547

Water-Soluble Vitamins with Minerals Tablets (USP) 1548

Xanthan Gum Solution (NF) 429

Xylazine 1453

Xylometazoline Hydrochloride Nasal Solution (USP) 795

Yohimbine Hydrochloride (USP) 1205

Yttrium Y 90 Ibritumomab Tiuxetan Injection (USP) 1890

EXCIPIENTS

Excipients, USP and NF Excipients, Listed by

Category (NF) 796, 1206, 1273, 1891

GENERAL CHAPTERS

Aerosols, Metered-Dose Inhalers, and Dry Powder

Inhalers (601) 584, 1470

Automated Methods of Analysis (16) (USP) 720

Bacterial Endotoxins Test (85) (USP) 435, 639, 1225

Biological and Chemical Identification of Articles of

Botanical Origin (563) (USP) 435

Botanical Extracts (565) (USP) 451

Bulk Density and Tapped Density (616) 901

Bulk Pharmaceutical Excipients-Certificate of Analysis

(1080) 901, 1650

Chromatography (621) (USP) 843, 959, 1227, 1916

Cleaning Glass Apparatus (1051) (USP) 1503

Containers (661) (USP) 453, 1492

Containers—Permeation (671) (USP) 456

Rights

Reserved.

2058

INDEX

Pharmacopeial Forum

Vol. 28(6) [Nov.-Dec. 2002]

Density

Solids (699) .(USP)

603

Disinfectants

and

Antiseptics (1072) (USP)

143

Disintegration

(701) (USP) 718, 1575

Disintegration

and

Dissolution

Nutritional Supplements

(2040)

1673

Good Compounding Practices (1075) (USP)

640

Good Manufacturing Practices

for

Bulk Pharmaceutical Excipients

(1078) (USP)

1504

Heavy Metals

(231) 1570

Inductively-Coupled Plasma (730) (USP)

1922

Injections

(1)

(USP)

Ill, 460, 1910

Light Diffraction Measurement

Particle Size

(429) . . . .895, 1293

Manufacturing Practices

for

Nutritional

Supplements (2750)

(USP) 534

Microbial Contamination Limits

for

Non-sterile Products (1111)

916

Microbial Attributes

Nonsterile Pharmaceutical Products—

Application

Water Activity Determination (1112)

(USP) 2009

Near Infrared Spectrophotometry (1119)

(USP) 1938

Optical Microscopy (776)

607, 847

Packaging—Unit of Use (1136)

(USP) 1302

Packaging Practice—Repackaging

Single Solid Oral Drug

Product into

Unit-Dose Container (1146) (USP)

.... 467

Particulate Matter

Injections

(788)

(USP)

1930

Paniculate Matter

Ophthalmic Solutions

(789) (USP) 1496

Particle Size Distribution

Analytical Sieving

(786) . . .

1493,

1581

Pharmaceutical Calculations

Prescription

Compounding (1160)

(USP) 476

Pharmacy Compounding

(795) (USP) 458

Powder Fineness

(811) 611

Powder Flow (1174)

618

Porosimetry

Mercury Intrusion

(267)

(USP)

893, 1290

Reference Standards

(11)

(USP) 111,433, 727, 1052, 1224, 1374, 1468, 1751,

1913

Residue

Ignition

(281) (USP) 112, 129, 1915

Shipping

and

Storage

Labile Preparations

(1186)

(USP) 495

Significant Change Guide

for

Bulk Pharmaceutical Excipients

(1195)

1662

Solution Calorimetry (518) (USP)

1299

Specific Surface Area (846)

612

Sterile Drug Products

for

Home

Use

(1206) (USP)

498

Stability Considerations

Dispensing Practice (1191)

(USP)

112

Standardized Imprint Codes

for

Solid Oral Dosage

Forms (1198)

(USP) 152

Tablet Friability (1216)

891

Thin-Layer Chromatographic Identification Test (201)

(USP) .. 1225

Total Organic Carbon

(643)

(USP)

1232, 1921

Uniformity

Dosage Units

(905) (USP) 1498, 1587

Validation

Alternative Microbiological Methods

(1223) (USP)

154

Water

for

Health Applications (1230)

1672

Weight Variation of Nutritional Supplements (2091)

(USP) . . . 1548

Written Prescription Drug Information—Guidelines

(1265)

(USP) 1538

X-Ray Diffraction

(941) (USP) 1500, 1733

X-Ray Diffraction Solids

(943) 905

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Air-Nitrous Oxide Certified Standard (USP)

1233

Bacterial Alkaline Protease Preparation (USP)

552

Benzil (USP)

1305

Bromelain (USP)

552

4-(Butylamino)benzoic Acid (USP)

553

dl-Camphene (USP)

1951

dl-10-Camphorsulfonic Acid (USP)

848

FD&C Blue No. 1

(USP) 115

Cesium Chloride (USP)

849

Cyclohexylmethanol (USP)

849

Dicyclohexyl (USP)

849

Diisobutylene (USP)

1305

l,2-Dilinoleoyl-3-oleoyl-rac-glycerol (USP)

849

l,2-Dilinoleoyl-3-palmitoyl-rac-glycerol (USP)

849

l,2-Dioleoyl-3-linoleoyl-rac-glycerol (USP)

849

Disodium Arsenate (USP)

1305

Dodecyl Sodium Sulfate (USP)

1234

Ethylbenzene (USP)

850

Ferulic acid (USP)

1951

Glucose (USP)

850

Gallic Acid (USP)

1234

Hexamethylenetetramine (USP)

850

Hexadecane (USP)

1305

Homatropine Hydrobromide (USP)

1305

Hydrocodone Diol (USP)

1306

Hydroxy Naphthol Blue (USP)

850

Iodoethane (USP)

1599

Isomaltotriose (USP)

1952

Lanthanum Oxide (USP)

851

Sodium Lauryl Sulfate (USP)

1234

Methylbenzothiazolone Hydrazone Hydrochloride (USP)

... 1599

Monoethanolamine (USP)

851

Ninhydrin (USP)

851

Ninhydrin TS (USP)

852

Nitric Acid, Lead-Free (USP)

851

l-Palmitoyl-2-oleoyl-3-linoleoyl-rac-glycerol(USP)

851

Protocatechuic acid (USP)

1952

Pyruvic Acid (USP)

1542

Triketohydrindene Hydrate (USP)

852

Triketohydrindene Hydrate TS (USP)

852

Tropine (USP)

1306

Undine (USP)

1234

Water (USP)

1233

Water, HPLC Grade (USP)

115

m-Xylene (USP)

1952

Indicator Test Papers

Methyl Green (USP)

1306

Methyl Green-Iodomercurate Paper (USP)

1306

Solutions

Standard Buffer Solution (USP)

718

Test Solutions

Gelatin

(USP)

1235

Volumetric Solutions

Hydrochloric Acid, Alcoholic, Tenth Molar (0.1

(USP)

. . 1235

Iodine, Tenth-Normal (0.1

(USP)

720

Lead Perchlorate, Hundreth Molar (0.01 M)(USP)

553

Potassium Hydroxide, Alcoholic, Tenth Molar (0.1

(USP)

1235

Tetrabutylammonium Hydroxide

Methanol

and

Isopropyl,

Alcohol 0.1

(USP)

1307

Reagent Footnotes

553, 1952

REFERENCE TABLES

Containers Specifications

for

Capsules

and Tablets

115, 852, 1235, 1952

Description

and

Relative

Solubility

116, 554, 853, 1236, 1542, 1953

Description

and

Relative Solubility

Harmonization

Articles

892

GENERAL SUBJECTS

An Alternative Approach

for

Evaluating

the

Linearity

Proportionality

Chromatographic Methods Over

Extended Dynamic Range,

Eric W. Kristensen, David

LeBlond, Marius Naris, and Arden Boersma

2018

Ambrosio, Thomas: See Medwick, Thomas

656

Bailey, Leonard:

See

Medwick, Thomas

656

Becker, Shawn

C. and

Bormel, F. Gail: Proposed Standards

for

Medical Gases:

Public Health Initiative

1312

The

United States Pharmacopeial Convention, Inc.

All Rights

Reserved.

Pharmacopeial Forum

Vol. 28(6) [Nov.-Dec. 2002]

INDEX

2059

Bevilacqua, Anthony C, Gross, Michael A., Lazar, Max S., Nowak,

Thomas M., and Stinavage, Paul S.: Water for Hemodialysis—

The Case for Compendial Standards 1684

Boersma, Arden: See Kristensen, Eric W. 2018

Biopharmaceutics

Biopharmaceutics Classification System: See Method

Consideration for Caco-2 Permeability Assessment in

the Biopharmaceutics Classification System, Sanna

Tolle-Sander

and James E. Polli 164

FIP Recommendations for Biopharmaceutical

Characterization of Herbal Medicinal Products by

Friedrich Lang, Konstantin Keller, Michael Ihrig,

Joy Oudtshoorn-Eckard, Helga

Moller,

Srini

Srinivasan,

He-ci 173

Bormel, F. Gail: see Becker, Shawn C 1312

Canceled Revision Proposals . . . 126, 564, 863, 1245, 1564, 1963

Changes in Reference Standards Prices

and Numbers 217, 713, 1039, 1361, 1729

Chromatography

Chromatographic Reagents Now Available 218, 714

Comparison of Microbiological Testing Practices in the Clinical,

Food, Water, and Pharmaceutical Microbiology in Relation

to the Microbiological Attributes of Nutritional and Dietary

Supplements by Anthony M. Cundell 964

Cundell, Anthony, M.: Comparison of Microbiological Testing

Practices in the Clinical, Food, Water, and Pharmaceutical

Microbiological in Relation to the Microbiological

Attributes of Nutritional and Dietary Supplements .... 964

Cundell, Anthony M.: Review of the Media Selection and

Incubation

Conditions for the Compendial Sterility and Microbial

Limit Tests 2034

Defining Column Equivalence, by Preston Poulter . 652

Donaghy, Colin and Smart, Matthew: Microwave Muffle Furance

Technology for Use in the Test for Residue on Ignition . 2029

Fifth Interim Revision Announcement 1369

First Interim Revision Announcement 25

Fourth Interim Revision Announcement 1045

Gross,

Michael A.: See Bevilacqua, Anthony C 1684

Halperin, Gideon and Marcus, Hadar: A New Assay System for

Accuracy Validation of Serum-antibody Titration

Method: Mechanistic and Operational Considerations 986

Harmonization

Allopurinol Oral Solution (USP) 1991

Atenolol Oral Solution (USP) 1991

Butylparaben (NF) 1967

Caffeine Injection (USP) 1992

Caffeine Oral Solution (USP) 1994

Carboxymethylcellulose Calcium (NF) 1052

Cellacefate (NF) 1053

Cellulose Acetate (NF) 1055

Sodium Chloride (USP) 1049

Croscarmellose Sodium (NF) 1567

Crospovidone (NF) 1057

Ethylcellulose (NF) 1568

Ethylparaben (NF) 1968

Etodolac Extended-Release Tablets (USP) 1996

Iodoethane (USP) 1599

Methylbenzothiazolone Hydrazone Hydrochloride (USP) ... 1599

Propylparaben (NF) 1970

Disintegration (701) 1575

Dissolution (711) (USP) 1972, 1981

Heavy Metals (231) 1570

Oral Solution Vehicle (USP) 1998

Oral Solution Vehicle Sugar Free (USP) 1998

Oral Suspension Vehicle 1999

Particle Size Distribution by Analytical Sieving (786) 1581

Piperacillin and Tazobactam Injection (USP) 2000

Piperacillin and Tazobactam for Injection (USP) 2001

Propylparaben (NF) 1970

Residue on Ignition (281) 129

Sodium Sulfite (NF) 2007

Uniformity of Dosage Units (905) 1588

Tazobactam Sodium (USP) 2003

He-ci, Yu: See Lang, Friedrich 173

Ihrig, Michael: See Lang, Friedrich 173

How To Submit Comments 20, 219, 715, 1042, 1363, 1731

Interim Revision Announcement

First 25

Second 225

Third 725

Fourth 1045

Fifth 1369

Sixth 1735

International Pharmaceutical Federation: See FIP

Recommendations for Biopharmaceutical

Characterization of Herbal Medicinal Products 173

In Vitro-In Vivo Correlations, by Lewis J. Leeson 1315

Keller, Konstantin: See Lang, Friedrich 173

Kirkpatrick Mary Ann: See Okeke, Claudia C 661

Kristensen, Eric W., LeBlond, David, Nans, Marius, and

Boersma, Arden: An Alternative Approach for Evaluating

the Linearity or Proportionality of Chromatographic

Methods Over an Extended Dynamic Range 2018

Lang, Friedrich, Keller, Konstantin.Ihrig, Michael,

Oudtshoorn-Eckard, Joyh, Moller, Helga,

Srinivasan, Srini, He-ci, Yu: FIP Recommendations

for Biopharmaceutical Characterization of Herbal

Medicinal Products 173

LeBlond, David: See Kristensen, Eric W. 2018

Lazar, Max S.: See Bevilacqua, Anthony C 1684

Leeson, Lewis J.: In Vitro-In Vivo Correlations 1315

Marcus, Hadar: See Halperin, Gideon 986

Medwick, Thomas, Bailey, Leonard, Ambrosio, Thomas,

and Okeke, Claudia C: Polypropylene Containers:

Status and Comments Received 656

Meltzer, Theodore H.: See Poirier, Stephen J. Bevilacqua,

Anthony C 1684

Method Consideration for Caco-2 Permeability

Assessment in the Biopharmaceutics Classification

System by Sanna Tolle-Sander and

James E. Polli 164

Microwave Muffle Furance Technology for Use in the Test for

Residue on Ignition, by Colin Donaghy and Matthew Smart 2029

Moller, Helga: See Lang, Friedrich 173

Nairn, J. Graham: See Okeke, Claudia C 661

Naris,

Marius: See Kristensen, Eric W. 2018

Near-IR Working Group: References for Near Infrared

Spectrophotometry—A Supplement to the New General

Chapter 2032

A New Assay System for Accuracy Validation of Serum-antibody

Titration Methods: Mechanistic and Operational

Considerations, by Gideon Halperin and Hadar Marcus ... 986

New Labeling Requirements Proposed for Neuromuscular

Blocking Agents (Paralyzing Agents) 218

New USP Reference Standards—Addenda and Errata 1361

Nowak, Thomas M.: See Bevilacqua, Anthony C 1684

Okeke, Claudia C, Kirkpatrick, Mary Ann F., and Nairn,

J. Graham: Review of Pharmaceutical Calculations

in Prescription Compounding (1160) 661

Okeke, Claudia C: See Medwick, Thomas 656

Packaging and Storage

Polypropylene Containers: Status and Comments

Received, by Thomas Medwick, Leonard Bailey,

Thomas Ambrosio, and Claudia C. Okeke 656

Pharmaceutical Education

Courses 20, 218, 714, 1041, 1362, 1730

Pharmacy Compounding

All Rights

Reserved.

2060

INDEX

Pharmacopeial Forum

Vol. 28(6) [Nov.-Dec. 2002]

Review of Pharmaceutical Calculations in Prescription

Compounding (1160), by Claudia C. Okeke, Mary

Ann F. Kirkpatrick, and J. Graham Nairn 661

Poirier, Stephen J.: and Meltzer, Theodore H.: Total Organic Carbon

Extractables from Polymeric and Glass Containers 1680

Policies and Announcements

Addenda and Errata to New USP Reference Standards .... 1361

Changes in Reference Standard Prices and

Numbers 217, 713, 1039, 1361, 1729

Chromatographic Reagents

Now Available 218, 714, 1362, 1730

Errata List for USP 25-NF 20 717, 1044, 1365, 1733

Glucosamine and Chondroitin Sulfate Tablets 1729

How to Submit Comments .... 20, 219, 715, 1042, 1363, 1731

Microwave Muffle Furnace Technology for Use in the Test for

Residue on Ignition 1729

New Labeling Requirements Proposed for

Neuromuscular Blocking Agents (Paralyzing Agents) . . 218, 714

Pharmacopeial Education

Courses 20, 218, 714, 1041, 1362, 1730

Update on the Annual Edition of

USP-NF

19,

218,

714,

1041,

1362,

1730

USP to Co-Sponsor International Open Conference on

Pharmacopeial Standards for Bulk Pharmaceuticals . . 1039, 1361

USP to Co-sponsor Joint Conference on Pharmaceutical

Excipients 1731

Polli, James E.: See Tolle-Sander, Sanna 164

Polypropylene Containers: Status and Comments

Received, by Thomas Medwick, Leonard Bailey,

Thomas Ambrosio, and Claudia C. Okeke 656

Poulter, Preston: Defining Column Equivalence 652

Proposed Standards for Medical Gases: A Public Health Initiative,

by Shawn C. Becker and F. Gail Bormel 1312

Previous PF Proposals Still Pending ... 117, 555, 1237, 1555, 1954

References for Near Infrared Spectrophotometry—A Supplement to

the New General Chapter by Near IR-Working Group . . . 2032

Review of Pharmaceutical Calculations in Prescription

Compounding (1160), by Claudia C. Okeke, Mary

Ann F. Kirkpatrick, and J. Graham Nairn 661

Review of the Media Selection and Incubation Conditions for the

Compendial Sterility and Microbial Limit Tests by Anthony

M. Cundell 2034

Second Interim Revision Announcement 225

Sixth Interim Revision Announcement 1737

Smart, Matthew: See Donaghy, Colin 2029

Soli, T.C.: See Bevilacqua, Anthony C 1684

Srinivasan, Srini: See Lang, Friedrich 173

Stinavage, Paul S.: See Bevilacqua, Anthony C 1684

Tolle-Sander, Sanna and Polli, James E.: See Method

Consideration for Caco-2 Permeability Assessment in

the Biopharmaceutics Classification System 164

Third Interim Revision Announcement 725

Total Organic Carbon Extractables from Polymeric and Glass

Containers, by Stephen J. Poirier and Theodore H. Meltzer 1680

Update on the Annual Edition of

USP-NF

19,

218,

714,

1041,

1362,

1730

USP to Co-Sponsor International Open Conference on

Pharmacopeial Standards for Bulk Pharmaceuticals . .1039, 1361

Water for Hemodialysis—The Case for Compendial Standards, by

Anthony C. Bevilacqua, Michael A. Gross, Max S. Lazar,

Thomas M. Nowak, T.C. Soli, and Paul S. Stinavage .... 1684

All

Rights

Reserved.

[Note—This index covers Vol. 30 No. 1, pp. 1–381, Vol. 30

No. 2, pp. 383–755, Vol. 30 No. 3, pp. 757–1114, Vol. 30 No.

4, pp. 1115–1530, Vol. 30 No. 5, pp. 1533–1939, Vol. 30 No.

6, pp. 1941–2328]

GENERAL NOTICES AND REQUIREMENTS (USP)

Signiﬁcant Figures and Tolerances (USP) ........... 424, 794

General Chapters (USP) ...................... 424, 795

Tests and Assays (USP) ......................425, 795, 1571

Preservation, Packaging, Storage, and Labeling

(USP)

...............................428, 798, 1574

MONOGRAPHS

Acepromazine Maleate Injection (USP) ............. 1161

Acesulfame Potassium (NF) ................... 591

Acetaminophen Oral Solution (USP) .............. 40

Acetaminophen Oral Suspension (USP) ............ 40, 1579

Acetaminophen Extended-Release Tablets (USP) ....... 1161

Acetaminophen and Aspirin Tablets (USP) ........... 40

Tablets Containing at Least Three of the Following—

Acetaminophen and Salts of Chlorpheniramine,

Dextromethorphan, and Phenylpropanolamine (USP)

.... 42

Capsules Containing at Least Three of the Following—

Acetaminophen and Salts of Chlorpheniramine,

Dextromethorphan, and Pseudoephedrine (USP)

....... 43

Oral Powder Containing at Least Three of the Following—

Acetaminophen and Salts of Chlorpheniramine,

Dextromethorphan, and Pseudoephedrine (USP)

....... 44

Oral Solution Containing at Least Three of the Following—

Acetaminophen and Salts of Chlorpheniramine,

Dextromethorphan, and Pseudoephedrine (USP)

....... 44

Tablets Containing at Least Three of the Following—

Acetaminophen and Salts of Chlorpheniramine,

Dextromethorphan, and Pseudoephedrine (USP)

....... 44

Acetaminophen and Codeine Phosphate Capsules (USP) ... 45

Acetaminophen and Codeine Phosphate Oral Solution

(USP)

............................... 46

Acetaminophen and Codeine Phosphate Oral Suspension

(USP)

............................... 46

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine

Succinate, and Pseudoephedrine Hydrochloride Oral Solution

(USP)

............................... 46

Acetaminophen and Diphenhydramine Citrate Tablets

(USP)

............................... 47

Acetaminophen, Diphenhydramine Hydrochloride, and

Pseudoephedrine Hydrochloride Tablets (USP)

....... 47

Acetaminophen and Pseudoephedrine Hydrochloride Tablets

(USP)

............................... 48

Acetohydroxamic Acid (USP) .................. 1579

Acetohydroxamic Acid Tablets (USP) ............. 49

Acetyltributyl Citrate (NF) .................... 2078

Acetyltriethyl Citrate (NF) .................... 2079

Acyclovir (USP) ..........................431, 802, 1143, 1580

Acyclovir Capsules (USP) ....................432, 1143

Acyclovir for Injection (USP) ..................433, 1144

Acyclovir Ointment (USP) ....................434, 1145

Acyclovir Oral Suspension (USP) ................435, 1145

Acyclovir Tablets (USP) .....................436, 1145

Adipic Acid (NF) .........................593, 1322

Albendazole Oral Suspension (USP) .............. 1163

Albuterol Tablets (USP) ...................... 50

Alclometasone Dipropionate Ointment (USP erratum) .... 787

Alcohol (USP) ...........................669, 1843

Dehydrated Alcohol (USP) ....................673, 1847

Alcohol in Dextrose Injection (USP) .............. 1581

Alendronate Sodium (USP) .................... 437

Alendronic Acid Tablets (USP) .................440, 804, 1146

Alfadex (NF) ............................ 202

Alprazolam Tablets (USP) .................... 51, 1582

Amantadine Hydrochloride Capsules (USP) .......... 51

Amifostine (USP) ......................... 52, 1974

Amifostine for Injection (USP) .................. 1976

Aminopentamide Sulfate (USP) ................. 1163

Aminosalicylate Sodium Tablets (USP) ............. 53

Ammonio Methacrylate Copolymer (NF) ............ 1666

Ammonium Sulfate (NF) .....................966, 1563

Amoxicillin Capsules (USP) ................... 1583

Amoxicillin and Clavulanate Potassium for Oral Suspension

(USP)

............................... 53

Amoxicillin Tablets (USP) .................... 1977

Amphetamine Sulfate (USP) ................... 443, 807

Amphetamine Sulfate Tablets (USP) .............. 54

Amphotericin B Lotion (USP) .................. 444

Amphotericin B Topical Emulsion (USP) ............ 445

Ampicillin Capsules (USP) .................... 55

Ampicillin Tablets (USP) ..................... 56

Anecortave Acetate (USP) .................... 445

Anecortave Acetate Injectable Suspension (USP) ....... 447

Anticoagulant Citrate Dextrose Solution (USP) ........ 1583

Antithrombin III Human (USP) ................. 56

Arginine Hydrochloride (USP) .................. 449

Ascorbic Acid Tablets (USP) ................... 60

L-Asparagine (NF) ......................... 205

Aspartic Acid (USP) ........................ 1163

Aspirin (USP) ........................... 1164

Aspirin, Caffeine, and Dihydrocodeine Bitartrate Capsules

(USP)

............................... 60

Atovaquone Oral Suspension (USP) ............... 449

Atracurium Besylate Injection (USP) .............. 450, 808

Avobenzone (USP) ........................ 1164

Azithromycin (USP) ........................ 450

Aztreonam (USP) ......................... 61

Baclofen Tablets (USP) ...................... 61

BCG Live (USP) .......................... 452

Benzocaine (USP) ......................... 809

Benzoyl Peroxide Gel (USP) ...................455, 1165

Benzoyl Peroxide Lotion (USP) ................. 456

Benzoyl Peroxide Topical Emulsion (USP) ........... 456

Benzyl Alcohol (NF) ....................... 690

Benzyl Benzoate Lotion (USP) ................. 457

Benzyl Benzoate Topical Emulsion (USP) ........... 457

Betadex (NF) ............................206, 595, 1323

Betahistine Hydrochloride (USP) ................ 1584

Betamethasone Dipropionate Lotion (USP) ........... 458

Betamethasone Dipropionate Topical Emulsion (USP) .... 459

Betamethasone Sodium Phosphate (USP) ............ 1166

Betamethasone Oral Solution (USP) ............... 460

Betamethasone Syrup (USP) ................... 460

Betamethasone Tablets (USP) .................. 62

Betamethasone Valerate Lotion (USP) ............. 461

Betamethasone Valerate Topical Emulsion (USP) ....... 461

Bethanechol Chloride (USP) ................... 1586

Bethanechol Chloride Tablets (USP) .............. 1587

Bethanechol Chloride (USP erratum) .............. 1155

Biological Indicators for Moist Heat, Dry Heat, and Gaseous

Modes of Sterilization, Metal, or Plastic Carriers (USP)

.. 63

Biological Indicators for Moist Heat, Dry Heat, and Gaseous

Modes of Sterilization, Liquid Spore Suspensions (USP)

.. 66

Bismuth Subsalicylate Oral Suspension (USP) ......... 1166

Bismuth Subsalicylate Tablets (USP) .............. 1167

Bisoprolol Fumarate (USP erratum) ............... 417

Bisoprolol Fumarate Tablets (USP) ............... 1588

Bisoprolol Fumarate and Hydrochlorothiazide Tablets

(USP erratum)

.......................... 1155

Red Blood Cells (USP) ...................... 69

Whole Blood (USP) ........................ 76

Bretylium Tosylate in Dextrose Injection (USP) ........ 1589

Brompheniramine Maleate and Pseudoephedrine Sulfate Oral

Solution (USP)

.......................... 79

Pharmacopeial Forum

2320

INDEX Vol. 30(6) [Nov.–Dec. 2004]

Index

Brompheniramine Maleate and Pseudoephedrine Sulfate Syrup

(USP)

............................... 80

Brompheniramine Maleate Tablets (USP) ............ 1978

Budesonide (USP) ......................... 1978

Bupivacaine Hydrochloride (USP) ................ 1589

Bupivacaine Hydrochloride in Dextrose Injection (USP) ... 1590

Bupropion Hydrochloride Extended-Release Tablets

(USP)

...............................810, 1562

Butalbital, Acetaminophen, and Caffeine Tablets (USP) ... 80

Butylparaben (NF) ......................... 1431

Caffeine (USP) ........................... 1168

Caffeine Citrate Injection (USP) .................462, 1590

Caffeine Citrate Oral Solution (USP) ..............464, 1593

Calamine Lotion (USP) ...................... 466

Phenolated Calamine Lotion (USP) ............... 466

Calamine Topical Suspension (USP) .............. 467

Phenolated Calamine Topical Suspension (USP) ........ 467

Calcitonin Salmon (USP) ..................... 1169

Calcitonin Salmon Injection (USP) ............... 1177

Calcitonin Salmon Nasal Solution (USP) ............ 1178

Calcium Carbonate, Magnesia, and Simethicone Tablets

(USP erratum)

.......................... 787

Calcium Silicate (NF) ....................... 595

Calcium Lactate Tablets (USP) .................. 81

Calcium Pantothenate Tablets (USP) .............. 81

Candelilla Wax (NF) .......................966, 1563

Caprylocaproyl Polyoxylglycerides (NF) ............ 1324

Carbidopa (USP) .......................... 811

Carbomer 940 (NF) ........................ 1328

Methionine C 11 Injection (USP) ................468, 811, 1146

Carboprost Tromethamine (USP) ................ 82

Carboxymethylcellulose Calcium (NF) ............. 695

Low-Substituted Carboxymethylcellulose Sodium (NF) ...966, 1563

Carboxymethylcellulose Sodium Suspension (USP) ...... 812

Cat’s Claw (USP) ......................... 1071

Powdered Cat’s Claw (USP) ................... 1075

Powdered Cat’s Claw Extract (USP) .............. 1075

Cat’s Claw Capsules (USP) .................... 1077

Cat’s Claw Tablets (USP) ..................... 1079

Cefonicid Sodium (USP erratum) ................ 787

Cefpodoxime Proxetil (USP) ................... 82

Cefprozil for Oral Suspension (USP) .............. 83

Cefuroxime Axetil for Oral Suspension (USP erratum) .... 417

Cellaburate (USP) .........................967, 697, 1146

Cellacefate (NF) .......................... 697

Microcrystalline Cellulose (NF) ................. 1433

Powdered Cellulose (NF) ..................... 1437

Powdered Cellulose (NF erratum) ................ 787

Cellulose Acetate (NF) ...................... 699

Cellulose Acetate Butyrate (NF) .................967, 697, 1146

Cephapirin Benzathine (USP) .................. 468

Cephapirin Benzathine Intramammary Infusion (USP) .... 470

Cephapirin for Injection (USP) .................. 470

Cephapirin Sodium (USP) .................... 471

Cephapirin Sodium Intramammary Infusion (USP) ...... 472

Cetrimonium Bromide (NF) ...................970, 1563

Cetyl Alcohol (NF) ........................ 970

Chaste Tree (USP) ......................... 546

Horse Chestnut (USP) ....................... 550

Powdered Horse Chestnut Extract (USP) ............ 550

Chlordiazepoxide Hydrochloride and Clidinium Bromide

Capsules (USP)

......................... 83

Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride

Oral Solution (USP)

....................... 84

Choline Bitartrate (USP) ..................... 950

Choline Chloride (USP) ...................... 951

Chondroitin Sulfate Sodium (USP) ...............197, 2068

Chondroitin Sulfate Sodium Tablets (USP) ...........200, 2071

Chromium Picolinate Tablets (USP) ............... 1664

Ciclopirox Olamine (USP) .................... 813

Ciclopirox Olamine Cream (USP) ................ 1595

Ciclopirox Olamine Topical Suspension (USP) ........ 1596

Ciproﬂoxacin (USP erratum) ................... 33

Ciproﬂoxacin Injection (USP) ..................473, 813, 1596

Citric Acid (USP) ......................... 677

Anhydrous Citric Acid (USP) ..................677, 1851

Citric Acid Monohydrate (USP) .................681, 1854

Clarithromycin (USP) ....................... 1179

Clarithromycin Tablets (USP) .................. 1182

Clarithromycin Extended-Release Tablets (USP) ....... 1183

Clarithromycin for Oral Suspension (USP) ........... 84

Clindamycin Injection (USP) ................... 1597

Clonidine Transdermal System (USP) .............. 84, 814

Clopidogrel Tablets (USP) .................... 820

Clorazepate Dipotassium (USP) ................. 1982

Clotrimazole Lotion (USP) .................... 473

Clotrimazole Topical Emulsion (USP) ............. 474

Red Clover (USP) ......................... 550

Powdered Red Clover Extract (USP) .............. 552

Clozapine (USP) .......................... 1984

Cocoa Butter (NF) ......................... 207

Codeine Phosphate (USP) .................... 1597

Colchicine Tablets (USP) ..................... 91

Copovidone (NF) ......................... 970

Hydrogenated Cottonseed Oil (NF) ............... 1563

Cranberry Liquid Preparation (USP) .............. 951

Croscarmellose Sodium (NF) ...................702, 1439

Cyclandelate (USP) ........................ 1985

Cyclizine Hydrochloride Tablets (USP) ............. 91

Cyclophosphamide Tablets (USP) ................ 1186

Cyclosporine Oral Solution (USP) ................ 92

Cysteine Hydrochloride (USP) .................. 1598

Dalteparin Sodium (USP) ..................... 1598

Demeclocycline Hydrochloride Tablets (USP) ......... 475

Demeclocycline Oral Suspension (USP) ............ 92

Desﬂurane (USP) ......................... 93, 1187

Desogestrel and Ethinyl Estradiol Tablets (USP) .......823, 1604

Dexamethasone Oral Solution (USP) .............. 93

Dexbrompheniramine Maleate and Pseudoephedrine Sulfate

Oral Solution (USP)

....................... 93

Dextroamphetamine Sulfate (USP) ............... 476, 831

Dextroamphetamine Sulfate Elixir (USP) ............ 1612

Dextroamphetamine Sulfate Oral Solution (USP) ....... 1613

Dextroamphetamine Sulfate Capsules (USP) .......... 94

Dextroamphetamine Sulfate Tablets (USP) ........... 94

Dextromethorphan Hydrobromide Oral Solution (USP) .... 95

Dextromethorphan Hydrobromide Syrup (USP) ........ 95

Dextrose Injection (USP) ..................... 1614

Dextrose and Sodium Chloride Injection (USP) ........ 1614

Diatrizoate Meglumine (USP) .................. 832

Diazepam (USP) .......................... 96

Dibutyl Phthalate (NF) ......................974, 1563

Diclofenac Sodium Delayed-Release Tablets (USP) ...... 1986

Diclofenac Sodium Extended-Release Tablets (USP) ..... 476

Dicyclomine Hydrochloride Capsules (USP) .......... 832

Dicyclomine Hydrochloride Tablets (USP) ........... 834

Diethylcarbamazine Citrate Tablets (USP) ........... 97

Diethylene Glycol Stearates (NF) ................974, 1563

Diethylstilbestrol Diphosphate Tablets (USP) ......... 1187

Diltiazem Hydrochloride Extended-Release Capsules

(USP)

............................... 478

Dimenhydrinate Oral Solution (USP) .............. 1190

Dimenhydrinate Syrup (USP) .................. 1190

Dimenhydrinate Tablets (USP) .................. 1191

Dimercaprol Injection (USP) ................... 1987

Diphenhydramine Hydrochloride Capsules (USP) ....... 97

Diphenhydramine and Pseudoephedrine Capsules (USP) ... 98

Diphenoxylate Hydrochloride and Atropine Sulfate Oral

Solution (USP)

.......................... 1987

Divalproex Sodium Delayed-Release Tablets (USP) ..... 835

Dobutamine in Dextrose Injection (USP) ............ 1615

Dopamine Hydrochloride and Dextrose Injection (USP) ... 1615

Pharmacopeial Forum

Vol. 30(6) [Nov.–Dec. 2004]

INDEX 2321

Index

Dorzolamide Hydrochloride (USP) ............... 99, 481

Doxepin Hydrochloride Capsules (USP) ............ 1987

Doxorubicin Hydrochloride (USP) ...............1147, 1968

Doxycycline Hyclate (USP) ................... 836

Dyphylline and Guaifenesin Tablets (USP) ........... 100

Echinacea angustifolia (USP) .................. 552

Powdered Echinacea angustifolia Extract (USP) ....... 554

Echinacea pallida (USP) ..................... 555

Powdered Echinacea pallida Extract (USP) .......... 556

Echinacea purpurea Aerial Parts (USP) ............ 557

Powdered Echinacea purpurea Extract (USP) ......... 561

Echinacea purpurea Root (USP) ................. 561

Multiple Electrolytes Injection Type 1 (USP) ......... 836

Multiple Electrolytes Injection Type 2 (USP) ......... 838

Multiple Electrolytes and Dextrose Injection Type 1

(USP)

...............................838, 1616

Multiple Electrolytes and Dextrose Injection Type 2

(USP)

............................... 838

Multiple Electrolytes and Dextrose Injection Type 2

(USP erratum)

.......................... 1566

Multiple Electrolytes and Dextrose Injection Type 3

(USP)

............................... 839

Enalapril Maleate and Hydrochlorothiazide Tablets (USP) .. 1988

Ensulizole (USP) .......................... 1191

Ephedrine (USP) ..........................839, 1562

Ephedrine Hydrochloride (USP) .................839, 1562

Ephedrine Sulfate (USP) .....................840, 1563

Ephedrine Sulfate Oral Solution (USP) ............. 482

Ephedrine Sulfate Syrup (USP) ................. 101

Epinephrine Nasal Solution (USP) ................ 1192

Epinephryl Borate Ophthalmic Solution (USP) ........ 1192

Ergoloid Mesylates Tablets (USP) ................ 1193

Ergoloid Mesylates Tablets (USP) ................ 1194

Ergoloid Mesylates Sublingual Tablets (USP) ......... 1196

Ergotamine Tartrate Tablets (USP) ................ 1198

Ergotamine Tartrate Sublingual Tablets (USP) ......... 1199

Ergotamine Tartrate and Caffeine Suppositories (USP) .... 1988

Ergotamine Tartrate and Caffeine Tablets (USP) ........ 1988

Erythromycin Ethylsuccinate Tablets (USP erratum) ..... 787

Estradiol Transdermal System (USP) .............. 1201

Estradiol and Norethindrone Acetate Tablets (USP) ...... 1989

Conjugated Estrogens (USP) ................... 840

Conjugated Estrogens Tablets (USP) .............. 101

Ethacrynic Acid Tablets (USP) .................. 1993

Ethosuximide Capsules (USP) .................. 102

Ethylcellulose (NF) ........................ 706

Ethylene Glycol Stearates (NF) .................974, 1563

Ethylparaben (NF) ......................... 1443

Etidronate Disodium (USP) .................... 1616

Etidronate Disodium Tablets (USP) ............... 1619

Etodolac Extended-Release Tablets (USP) ........... 1203

Etoposide (USP) .......................... 103

Famotidine (USP erratum) .................... 1566

Famotidine for Oral Suspension (USP) ............. 1993

Famotidine Tablets (USP) .................... 1995

Felodipine Extended-Release Tablets (USP) .......... 482

Fenbendazole (USP) ........................ 1205

Fexofenadine Hydrochloride (USP) ...............841, 1208

Fexofenadine Hydrochloride Capsules (USP) ......... 845

Fexofenadine Hydrochloride Tablets (USP) .......... 1997

Cryopreserved Human Fibroblast-Derived Dermal Substitute

(USP)

............................... 1211

Human Fibroblast-Derived Temporary Skin Substitute

(USP)

............................... 1221

Finasteride Tablets (USP) ..................... 1620

Fluconazole (USP) ......................... 103

Flucytosine (USP) ......................... 1621

Fludarabine Phosphate (USP) .................. 1621

Flumazenil (USP) ......................... 1223

Fluorodopa F 18 Injection (USP) ................ 486

Fluoxetine Hydrochloride (USP) ................. 848

Fluoxetine Capsules (USP) .................... 849

Fluoxetine Delayed-Release Capsules (USP) .......... 849

Fluoxetine Tablets (USP) ..................... 852

Fluoxymesterone Tablets (USP) ................. 105

Flurandrenolide Lotion (USP) .................. 489

Flurandrenolide Topical Emulsion (USP) ............ 489

Flurazepam Hydrochloride (USP) ................490, 1229

Fluticasone Propionate (USP) .................. 1230

Fluvastatin Sodium (USP) .................... 1234

Fluvastatin Capsules (USP) .................... 1237

Fluvoxamine Maleate (USP) ................... 1240

Fluvoxamine Maleate Tablets (USP) ..............1243, 1622

Fosinopril Sodium (USP) ..................... 2001

Fosinopril Sodium Tablets (USP) ................ 2004

Fosinopril Sodium and Hydrochlorothiazide Tablets

(USP)

............................... 2006

Galactose (NF) ........................... 600

Gellan Gum (NF) ......................... 1328

Gemcitabine for Injection (USP) ................. 1246

Gemﬁbrozil (USP) ......................... 30

Gemﬁbrozil Capsules (USP) ................... 1246

Gemﬁbrozil Tablets (USP) .................... 1247

American Ginseng (USP) ..................... 563

Powdered American Ginseng (USP) ............... 564

Powdered American Ginseng Extract (USP) .......... 564

American Ginseng Capsules (USP) ............... 565

American Ginseng Tablets (USP) ................ 567

Asian Ginseng (USP) ....................... 569

Powdered Asian Ginseng (USP) ................. 570

Powdered Asian Ginseng Extract (USP) ............ 570

Asian Ginseng Capsules (USP) ................. 571

Asian Ginseng Tablets (USP) .................. 573

Glimepiride (USP) ......................... 1247

Glucagon (USP) ..........................412, 1625

Glucosamine and Chondroitin Sulfate Sodium Tablets

(USP)

...............................201, 2072

Glyceryl Distearate (NF) .....................975, 1563

Glyceryl Monolinoleate (NF) ...................975, 1564

Glyceryl Monooleate (NF) ....................975, 1564

Glyceryl Monostearate (NF) ................... 975

Glycopyrrolate Tablets (USP) .................. 105

Goldenseal (USP) ......................... 952

Powdered Goldenseal (USP) ................... 953

Powdered Goldenseal Extract (USP) .............. 954

Gonadorelin Acetate (USP) .................... 1250

Graftskin (USP) .......................... 490

Guaifenesin Capsules (USP) ................... 106

Guaifenesin Oral Solution (USP) ................ 107

Guaifenesin Syrup (USP) ..................... 107

Guaifenesin Tablets (USP) .................... 107

Guaifenesin and Codeine Phosphate Oral Solution (USP) .. 108

Guaifenesin and Codeine Phosphate Syrup (USP) ....... 108

Helium (USP) ........................... 502

Homatropine Hydrobromide (USP) ............... 502

Homosalate (USP) ......................... 108

Hydrocodone Bitartrate (USP) ..................1148, 1628

Hydrocodone Bitartrate and Homatropine Methylbromide

Tablets (USP)

.......................... 853

Hydrocodone Bitartrate and Acetaminophen Tablets

(USP)

............................... 109

Hydrocortisone Acetate Lotion (USP) .............. 504

Hydrocortisone Acetate Ointment (USP) ............ 504

Hydrocortisone Acetate Topical Emulsion (USP) ....... 504

Hydrocortisone Lotion (USP) .................. 505

Hydrocortisone Topical Emulsion (USP) ............ 506

Hydrogen Peroxide Concentrate (USP) ............. 1629

Hydromorphone Hydrochloride (USP) ............. 1254

Hydroxyethyl Cellulose (NF) ................... 709

Hydroxypropyl Cellulose (NF) .................. 335

Low-Substituted Hydroxypropyl Cellulose (NF) ........ 338

Pharmacopeial Forum

2322

INDEX Vol. 30(6) [Nov.–Dec. 2004]

Index

Hydroxyzine Hydrochloride Tablets (USP) ........... 507

Hymetellose (NF) .........................975, 1564

Hyoscyamine Sulfate Elixir (USP) ................ 857

Hyoscyamine Sulfate Injection (USP) .............. 858

Hyoscyamine Sulfate Oral Solution (USP) ........... 860

Hyoscyamine Sulfate Tablets (USP) ............... 861

Hypromellose Acetate Succinate (NF) .............976, 2079

Hypromellose Ophthalmic Solution (USP) ........... 862

Hypromellose Phthalate (NF) .................. 984

Hypromellose Acetate Succinate (NF) .............976, 2079

Ibuprofen Oral Suspension (USP) ................ 110

Indinavir Sulfate (USP) ...................... 862

Indinavir Sulfate Capsules (USP) ................ 508

Indomethacin Topical Gel (USP) ................ 866

Indomethacin Oral Suspension (USP) .............. 110

Insulin (USP) ............................ 1629

Insulin Human Injection (USP) ................. 1630

Ipecac (USP) ............................ 866

Powdered Ipecac (USP) ...................... 867

Irbesartan (USP) .......................... 110

Isoﬂurane (USP) .......................... 1255

Isoproterenol Hydrochloride Injection (USP) .......... 510

Isosorbide Dinitrate Sublingual Tablets (USP) ......... 113

Diluted Isosorbide Mononitrate (USP) ............. 868

Isosorbide Mononitrate Extended-Release Tablets (USP) ... 871

Isradipine Capsules (USP) .................... 510

Ivermectin (USP) ......................... 114, 875

Kanamycin Sulfate Capsules (USP) ............... 120

Ketoconazole Tablets (USP) ................... 1256

Lamivudine (USP) ......................... 881

Lansoprazole (USP) ........................ 2010

Leuprolide Acetate (USP) .................... 882

Levodopa (USP) .......................... 888

Levodopa Tablets (USP) ..................... 890

Levothyroxine Sodium (USP) .................. 1630

Levothyroxine Sodium Tablets (USP) .............. 120

Powdered Licorice Extract (USP) ................ 574

Lidocaine Hydrochloride (USP) ................. 1256

Lidocaine Hydrochloride and Dextrose Injection (USP) ... 1631

Lidocaine Hydrochloride and Epinephrine Injection (USP) .. 1257

Lindane Lotion (USP) ....................... 512

Lindane Topical Emulsion (USP) ................ 512

Linoleoyl Polyoxylglycerides (NF) ............... 1328

Liothyronine Sodium (USP) ................... 1631

Liotrix Tablets (USP) ....................... 1632

Lisinopril Tablets (USP) ..................... 121

Lithium Carbonate Extended-Release Tablets (USP) ..... 414

Loperamide Hydrochloride Oral Solution (USP) ........ 30

Loperamide Hydrochloride Tablets (USP) ...........122, 1633

Loratadine (USP) .........................891, 2011

Loratadine Oral Solution (USP) .................122, 415, 1258, 1969, 2014

Losartan Potassium (USP) .................... 125

Lovastatin (USP) .......................... 30

Lycopene (USP) ..........................574, 2073

Lycopene Preparation (USP) ...................576, 2075

Lycopene Tomato Extract (USP) ................. 578

Lypressin Nasal Solution (USP) ................. 893

Lysine Hydrochloride Tablets (USP) .............. 1665

Mafenide Acetate (USP) ..................... 1258

Mafenide Acetate for Topical Solution (USP) ......... 1259

Magnesium Chloride (USP) ................... 893

Magnesium Stearate (NF) ..................... 340

Malathion Lotion (USP) ..................... 513

Malathion Topical Emulsion (USP) ............... 513

Maleic Acid (NF) ......................... 602

Maltitol Solution (NF) ......................984, 1564

Maltol (NF) ............................. 984

Maltose (NF) ............................ 985

Mangafodipir Trisodium (USP) ................. 2014

Meclizine Hydrochloride Tablets (USP) ............ 127

Meﬂoquine Hydrochloride (USP) ................ 1260

Megestrol Acetate Oral Suspension (USP) ........... 2015

Melengestrol Acetate (USP) ................... 893

Meperidine Hydrochloride Oral Solution (USP) ........ 128

Meperidine Hydrochloride Syrup (USP) ............ 129

Mephobarbital (USP) ....................... 1634

Mephobarbital Tablets (USP) ................... 415, 514

Mepivacaine Hydrochloride Injection (USP) .......... 2017

Meprobamate Tablets (USP) ................... 129

Mercaptopurine Tablets (USP) .................. 1261

Mesalamine Extended-Release Capsules (USP) ........ 896

Mesoridazine Besylate (USP) .................. 1262

Metformin Hydrochloride Tablets (USP) ............ 897

Methadone Hydrochloride Oral Solution (USP) ........ 130

Methenamine Tablets (USP) ................... 130

Methocarbamol Tablets (USP) .................. 130

Methscopolamine Bromide (USP) ................ 899

Methylbenzethonium Chloride Lotion (USP) .......... 515

Methylbenzethonium Chloride Topical Emulsion (USP) ... 515

Methylbenzethonium Chloride Topical Powder (USP) .... 516

Methylparaben (NF) ........................ 1445

Methylphenidate Hydrochloride (USP) ............. 731

Methylphenidate Hydrochloride Extended-Release Tablets

(USP)

............................... 1263

Methylphenidate Hydrochloride Tablets (USP) ........ 131

Metoprolol Succinate (USP) ................... 1263

Metrifonate (USP erratum) .................... 1155

Mirtazapine (USP) ......................... 900

Mirtazapine Tablets (USP) .................... 902

Mitoxantrone Hydrochloride (USP) ............... 785

Mitoxantrone Injection (USP) .................. 785

Mitoxantrone Injection (USP erratum) ............. 1155

Modaﬁnil (USP) .......................... 1634

Modaﬁnil Tablets (USP) ..................... 1636

Mono- and Di-glyclycerides (NF) ................ 1330

Monoglyceride Citrate (NF) ................... 2088

Morantel Tartrate (USP) ..................... 2017

Morphine Sulfate (USP) ..................... 1639

Myristic Acid (NF) ........................ 1666

Nabumetone Tablets (USP) .................... 2019

Nadolol and Bendroﬂumethiazide Tablets (USP) ....... 132

Nalidixic Acid (USP) ....................... 132

Nalidixic Acid Oral Suspension (USP) ............. 415

Naltrexone Hydrochloride (USP) ................ 2019

Naproxen (USP) .......................... 904

Naproxen Delayed-Release Tablets (USP) ........... 1264

Naproxen Oral Suspension (USP) ................ 133

Narasin Granular (USP erratum) ................. 33

Naratriptan Hydrochloride (USP) ................ 1266

Naratriptan Tablets (USP) ..................... 1268

Neomycin Sulfate and Flurandrenolide Lotion (USP) ..... 516

Neomycin Sulfate and Flurandrenolide Topical Emulsion

(USP)

............................... 516

Neomycin Sulfate and Hydrocortisone Acetate Cream

(USP)

...............................891, 2011

Neomycin Sulfate and Hydrocortisone Acetate Lotion

(USP)

............................... 517

Neomycin Sulfate and Hydrocortisone Acetate Ointment

(USP)

............................... 518

Neomycin Sulfate and Hydrocortisone Acetate Ophthalmic

Ointment (USP)

......................... 518

Neomycin Sulfate and Hydrocortisone Acetate Topical Emulsion

(USP)

............................... 518

Neomycin and Polymyxin B Sulfates, Bacitracin, and

Hydrocortisone Acetate Ointment (USP)

........... 519

Neomycin and Polymyxin B Sulfates, Bacitracin, and

Hydrocortisone Acetate Ophthalmic Ointment (USP)

.... 519

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and

Hydrocortisone Acetate Ophthalmic Ointment (USP)

.... 519

Neomycin and Polymyxin B Sulfates, Gramicidin, and

Hydrocortisone Acetate Cream (USP)

............. 520

Pharmacopeial Forum

Vol. 30(6) [Nov.–Dec. 2004]

INDEX 2323

Index

Neomycin and Polymyxin B Sulfates and Hydrocortisone

Acetate Cream (USP)

...................... 520

Neomycin Sulfate Oral Solution (USP) ............. 133

Neostigmine Bromide Tablets (USP) .............. 133

Netilmicin Sulfate (USP) ..................... 134

Netilmicin Sulfate Injection (USP) ............... 136

Nevirapine (USP) ......................... 136

Niacinamide Tablets (USP) .................... 139

Nifedipine Extended-Release Tablets (USP) .......... 1269

Nitrofurantoin Oral Suspension (USP) ............. 520

Nitrofurantoin Capsules (USP) .................. 139

Nitrogen (NF) ........................... 604

Nitrogen 97 Percent (NF) ..................... 605

Nitroglycerin Sublingual Tablets (USP) ............. 1272

Nitroglycerin Tablets (USP) ................... 1272

Nitrous Oxide (USP) ....................... 521

Nystatin (USP) ........................... 141

Nystatin Lotion (USP) ...................... 522

Nystatin Topical Emulsion (USP) ................ 522

Nystatin, Neomycin Sulfate, Thiostrepton, and Triamcinolone

Acetonide Ointment (USP)

................... 2020

Nystatin for Oral Suspension (USP) ............... 143

Octisalate (USP) .......................... 904

Octocrylene (USP) ......................... 905

Octocrylene (USP erratum) .................... 1566

Oﬂoxacin (USP) .......................... 1274

Oleoyl Polyoxylglycerides (NF) ................. 1330

Omeprazole (USP) ......................... 522

Omeprazole Delayed-Release Capsules (USP) ......... 143

Ondansetron (USP) ........................ 2021

Ondansetron Oral Solution (USP) ................ 905

Ondansetron Orally Disintegrating Tablets (USP) ....... 2024

Opium (USP) ............................ 907

Orphenadrine Citrate (USP) ................... 523

Orphenadrine Citrate Injection (USP) .............. 524

Oxandrolone (USP) ........................ 148

Oxybutynin Chloride (USP) ................... 908

Oxybutynin Chloride Extended-Release Tablets (USP) ....525, 1276

Oxycodone Hydrochloride (USP) ................ 2027

Oxycodone Hydrochloride Oral Solution (USP) ........ 150

Oxycodone and Acetaminophen Capsules (USP) ....... 151

Oxycodone and Acetaminophen Tablets (USP) ........ 151

Oxycodone and Aspirin Tablets (USP) ............. 152

Oxytocin Injection (USP) ..................... 153

Paclitaxel (USP) .......................... 1279

Padimate O Lotion (USP) ..................... 527

Padimate O Topical Emulsion (USP) .............. 527

Palmitic Acid (NF) ........................ 987

Paroxetine Hydrochloride (USP) .................911, 1282

Paroxetine Tablets (USP) .....................919, 1150

Penicillamine Capsules (USP) .................. 153

Penicillin G Procaine, Neomycin and Polymyxin B Sulfates, and

Hydrocortisone Acetate Topical Suspension (USP)

..... 528

Penicillin G Potassium for Injection (USP) ........... 154

Penicillin G Sodium for Injection (USP) ............ 154

Pentobarbital (USP) ........................ 154

Pentobarbital Sodium (USP) ................... 157

Pepsin (USP) ............................ 349

Perﬂutren Protein-Type A Microspheres for Injection

(USP)

............................... 1639

Perﬂutren Protein-Type A Microspheres Injectable Suspension

(USP)

............................... 1640

Camphorated Phenol Topical Solution (USP) ......... 922

Phenolsulfonphthalein (NF) ................... 988

2-Phenoxyethanol (NF) ...................... 207

Phentermine Hydrochloride Capsules (USP) .......... 159

Phentermine Hydrochloride Tablets (USP) ........... 160

Phenylephrine Bitartrate (USP) .................923, 2028

Phenylethyl Alcohol (USP) .................... 1290

Phenylpropanolamine Hydrochloride Capsules (USP) ..... 161

Phenylpropanolamine Hydrochloride Oral Solution (USP) .. 161

Phenylpropanolamine Hydrochloride Tablets (USP) ...... 162

Phenyltoloxamine Citrate (USP) .................162, 1291

Phenytoin Oral Suspension (USP) ................ 528

Phenytoin Sodium (USP) ..................... 2030

Physostigmine Salicylate Injection (USP) ............ 2031

Pimozide Tablets (USP) ...................... 164

Pindolol Tablets (USP) ...................... 165

Piperazine Citrate Tablets (USP) ................. 165

Platelets (USP) ........................... 166

Polydecene (NF) .......................... 1331

Polyisobutylene (NF) .......................990, 1564, 2089

Polyoxyl 35 Castor Oil (NF) ................... 1668

Polyoxyl Stearyl Ether (NF) ................... 605

Potassium Chloride in Dextrose Injection (USP) ........ 1640

Potassium Chloride in Dextrose and Sodium Chloride Injection

(USP)

............................... 1641

Potassium Chloride Extended-Release Tablets

(USP erratum)

.......................... 33

Povidone (USP) .......................... 1292

Prednisolone (USP) ........................ 1641

Prednisolone Acetate (USP) ................... 1642

Prednisone Oral Solution (USP) ................. 169

Prilocaine (USP) .......................... 1643

Procainamide Hydrochloride (USP erratum) .......... 787

Procyclidine Hydrochloride Tablets (USP) ........... 169

Propantheline Bromide Tablets (USP) .............. 170

Propofol (USP) ........................... 1645

Propoxycaine Hydrochloride (USP) ............... 2032

Propoxyphene Hydrochloride (USP) .............. 529, 925

Propoxyphene Napsylate (USP) ................. 927

Propoxyphene Hydrochloride and Acetaminophen Tablets

(USP)

............................... 170

Propoxyphene Napsylate Oral Suspension (USP) ....... 171

Propylparaben (NF) ........................ 1448

Pseudoephedrine Hydrochloride Oral Solution (USP) ..... 171

Pseudoephedrine Hydrochloride Syrup (USP) ......... 172

Pseudoephedrine Hydrochloride Tablets (USP) ........ 172

Pseudoephedrine Hydrochloride, Carbinoxamine Maleate, and

Dextromethorphan Hydrobromide Oral Solution (USP)

... 173

Psyllium Hemicellulose (USP) .................. 173

Psyllium Husk (USP) ....................... 2077

Pygeum (USP) ........................... 954

Pygeum Extract (USP) ...................... 956

Pygeum Capsules (USP) ..................... 959

Pyridoxine Hydrochloride Injection (USP) ........... 583

Pyridoxine Hydrochloride Tablets (USP) ............ 177

Pyrilamine Maleate Tablets (USP) ................ 177

Pyrimethamine Tablets (USP) .................. 929

Quazepam Tablets (USP) ..................... 531

Quinidine Gluconate Extended-Release Tablets (USP) .... 31

Ramipril (USP) .......................... 2032

Ranitidine Hydrochloride (USP) ................. 2033

Ranitidine Oral Solution (USP) ................. 2036

Oral Rehydration Salts (USP) .................. 1646

Resorcinol and Sulfur Lotion (USP) ............... 531

Resorcinol and Sulfur Topical Suspension (USP) ....... 531

Riboﬂavin (USP) ......................... 929

Rifampin and Isoniazid Capsules (USP) ............ 533

Rifampin, Isoniazid, and Pyrazinamide Tablets (USP) .... 534

Rifampin, Isoniazid, Pyrazinamide, and Ethambutol

Hydrochloride Tablets (USP)

.................. 535

Ringer’s and Dextrose Injection (USP) .............1293, 1647

Ropivacaine Hydrochloride (USP) ................ 2039

Saccharin (NF) ........................... 1450

Saccharin Calcium (USP) ..................... 1423

Saccharin Sodium (USP) ..................... 1427

Saccharin Sodium Tablets (USP) ................ 536

Powdered St. John’s Wort Extract (USP) ............ 584

Sargramostin (USP) ........................ 2044

Selenium Sulﬁde Lotion (USP) ................. 537

Selenium Sulﬁde Topical Suspension (USP) .......... 537

Pharmacopeial Forum

2324

INDEX Vol. 30(6) [Nov.–Dec. 2004]

Index

Sesame Oil (NF) ..........................608, 1668

Sevoﬂurane (USP) ......................... 178

Simethicone (USP) ........................184, 1293

Simethicone Capsules (USP) ................... 1294

Simethicone Emulsion (USP) ..................184, 1294

Simethicone Oral Suspension (USP) .............. 1294

Simethicone Tablets (USP) .................... 1295

Simethicone Emulsion (USP) ..................184, 1294

Simvastatin (USP) ......................... 1647

Sodium Caprylate (NF) ...................... 990

Sodium Cetostearyl Sulfate (NF) ................992, 1564

Sodium Cetostearyl Sulfate (NF erratum) ............ 1566

Sodium Chloride (USP) ...................... 685

Sodium Chloride and Dextrose Tablets (USP) ......... 1647

Tribasic Sodium Phosphate (NF) ................992, 1564

Sodium Starch Glycolate (NF) .................. 1454

Sodium Stearyl Fumarate (NF) .................. 609

Sodium Sulﬁte (NF) ........................ 609

Sodium Tartrate (NF) ....................... 611

Somatropin (USP) ......................... 1295

Somatropin for Injection (USP) ................. 1299

Sorbitol (NF) ............................992, 1564

Sorbitol Solution (USP) ......................929, 1563

Anhydrized Liquid Sorbitol (NF) ................993, 1669

Noncrystallizing Sorbitol Solution (NF) ............995, 1564

Sotalol Hydrochloride (USP) ...................33, 2044

Soybean Oil (USP) ........................ 1648

Hydrogenated Soybean Oil (NF) .................995, 1564

Spironolactone Oral Suspension (USP) ............. 929

Spironolactone and Hydrochlorothiazide Oral Suspension

(USP)

............................... 930

Starch (NF) ............................. 714

Modiﬁed Starch (NF) .......................995, 1334

Pregelatinized Starch (NF) .................... 997

Corn Starch (NF) .........................715, 1457, 1862

Potato Starch (NF) .........................718, 1460, 1865

Rice Starch (NF) .......................... 721

Tapioca Starch (NF) ........................998, 1336, 1672

Wheat Starch (NF) .........................723, 1462, 1868

Stavudine (USP) .......................... 932

Stavudine Capsules (USP) .................... 934

Stavudine for Oral Solution (USP) ............... 937

Stearoyl Polyoxylglycerides (NF) ................ 1336

Succinic Acid (NF) ........................ 612

Sufentanil Citrate Injection (USP) ................ 2045

Sulﬁsoxazole (USP) ........................ 1301

Sumatriptan (USP) ......................... 184

Sumatriptan Nasal Spray (USP) ................. 2045

Tagatose (NF) ........................... 1672

Talc (USP) ............................. 1857

Terbutaline Sulfate Tablets (USP) ................ 188

Testosterone Enanthate (USP) .................. 1648

Tetracaine Hydrochloride in Dextrose Injection (USP) .... 1648

Theophylline in Dextrose Injection (USP) ........... 1649

Theophylline, Ephedrine Hydrochloride, and Phenobarbital

Tablets (USP)

.......................... 189

Thiamine Hydrochloride Tablets (USP) ............. 190

Thioguanine (USP) ........................ 2049

Tiagabine Hydrochloride (USP) ................. 1649

Tiamulin Fumarate (USP) ..................... 190, 938

Tiamulin Fumarate (USP erratum) ................ 33

Timolol Maleate Tablets (USP) ................. 191

Titanium Dioxide (USP) ..................... 1301

Titanium Dioxide (USP) ..................... 1304

Tolcapone (USP) ..........................939, 2051

Tolcapone Tablets (USP) ..................... 943

Tomato Extract Containing Lycopene Capsules (USP) .... 734

Topiramate (USP) ......................... 1307

Triamcinolone Acetonide (USP) ................. 945

Triamcinolone Acetonide Lotion (USP) ............. 538

Triamcinolone Acetonide Topical Emulsion (USP) ...... 538

Tributyl Citrate (NF) ....................... 2091

Triclosan (USP) .......................... 2054

Triethyl Citrate (NF) ........................ 2091

Medium Chain Triglycerides (NF) ................ 998

Tripelennamine Hydrochloride (USP) .............. 1312

Triprolidine and Pseudoephedrine Hydrochlorides Tablets

(USP)

............................... 192

Trolamine Salicylate (USP) .................... 1312

Ubidecarenone Capsules (USP) ................. 202

Ursodiol (USP) ........................... 1313

Valrubicin (USP) .......................... 946

Vancomycin Hydrochloride (USP) ................ 2055

Vancomycin Hydrochloride for Oral Solution (USP) ..... 193

Vecuronium Bromide (USP) ...................193, 2057

Verteporﬁn (USP) ......................... 947

Vinorelbine Injection (USP) ................... 1314

Vitamin A (USP) ......................... 415

Oil- and Water-Soluble Vitamins Tablets (USP) ........ 585

Oil- and Water-Soluble Vitamins with Minerals Oral Solution

(USP)

............................... 585

Oil- and Water-Soluble Vitamins with Minerals Tablets

(USP)

............................... 585

Water-Soluble Vitamins Tablets (USP) ............. 587

Water-Soluble Vitamins with Minerals Tablets (USP) ..... 587

Water for Injection (USP) ..................... 1650

Bacteriostatic Water for Injection (USP) ............ 1315

Sterile Water for Inhalation (USP) ................ 1316

Sterile Water for Injection (USP) ................ 1316

Pure Steam (USP) ......................... 1651

Puriﬁed Water (USP) ....................... 1316

Sterile Puriﬁed Water (USP) ...................947, 1317

Water for Hemodialysis (USP) .................. 1317

Water for Hemodialysis (USP erratum) ............. 1566

White Lotion (USP) ........................ 538

Small Intestinal Submucosa Wound Matrix (USP) ......538, 1652

Zileuton (USP) ........................... 948

Zinc Sulﬁde Topical Suspension (USP) ............. 546

EXCIPIENTS

Excipients, USP and NF Excipients, Listed

by Category (NF)

........................587, 961, 1317, 1659, 2062

GENERAL CHAPTERS

Acid-neutralizing Capacity h301i (USP) ............ 1006

Aerosols, Metered Dose Inhalers, and Dry Powder Inhalers h601i

(USP)

............................... 1342

Alcohol Determination h611i (USP) ...............617, 1378

Analytical Data—Interpretation and Treatment h1010i

(USP)

............................... 236

Ancillary Materials for Cell, Gene, and Tissue-Engineered

Products h1043i (USP)

..................... 629

Antibiotics—Microbial Assays h81i (USP) ........... 1002

Antimicrobial Agents—Content h341i (USP) ......... 1678

Application of Water Activity Determination to Nonsterile

Pharmaceutical Products h1112i (USP)

............ 1709

Biological Indicators—Resistance Performance Tests h55i

(USP)

............................... 212

Chromatography h621i (USP) ..................228, 618, 1007, 1687, 2094

Cleaning Glass Apparatus h1051i (USP) ............ 264

Disinfectants and Antiseptics h1072i (USP) .......... 2108

Dissolution h711i (USP) ..................... 234

The Dissolution Procedure: Development and Validation h1092i

(USP)

............................... 351

Effusivity h1073i (USP) ..................... 1489

Elastomeric Closures for Injections h381i (USP) ....... 220

Emergency Medical Services Vehicles and Ambulances—

Storage of Preparations h1070i (USP)

............ 1706

Environmentally Sensitive Preparations h386i (USP) ..... 1680

Genotoxicity Testing h1082i (USP) ............... 264

Globule Size Distribution in Lipid Injectable Emulsions h729i

(USP)

............................... 2235

Pharmacopeial Forum

Vol. 30(6) [Nov.–Dec. 2004]

INDEX 2325

Index

Good Packaging Practices h1177i (USP) ............ 2152

Good Repackaging Practices h1178i (USP) .......... 2156

Good Storage and Shipping Practices h1079i (USP) ..... 2118

Heavy Metals h231i (USP) ....................217, 614, 1004

Impurities in Ofﬁcial Articles h1086i (USP erratum) ..... 787

Inductively-Coupled Plasma h730i (USP) ........... 1022

Instrumentation for Analysis of High Purity Pharmaceutical

Waters h1232i (USP)

......................303, 1806

Insulin Assays h121i (USP) ................... 1675

Intrinsic Dissolution h1087i (USP) ............... 2130

Medicine Dropper h1101i (USP) ................. 2137

Microbial Enumeration Tests—Nutritional and Dietary

Supplements h2021i (USP erratum)

.............. 1566

Microbiological Attributes of Nonsterile Nutritional and Dietary

Supplements h2023i (USP)

................... 1818

Microbiological Best Laboratory Practices h1117i (USP) ... 1713

Near-Infrared Spectrophotometry h1119i (USP) ........ 2137

Optical Microscopy h776i (USP) ................2209, 2212

Optical Rotation h781i (USP erratum) ............. 787

Osmolality and Osmolarity h785i (USP) ............ 1702

Packaging—Unit of Use h1136i (USP) ............. 1722

Particle Size Distribution Estimation by Analytical Sieving h786i

(USP)

...............................2216, 2219

Pharmacopeial Harmonization h1196i (USP) .......... 1151

Powder Fineness h811i (USP erratum) ............. 417

Powder Flow h1174i (USP) ...................2226, 2226

Raman Spectrophotometry h1120i (USP) ............ 2139

Sensitization Testing h1184i (USP) ............... 289

Speciﬁc Surface Area h846i (USP) ............... 1465

Spectrophotometry and Light-Scattering h851i (USP) ..... 1703

Sterility Testing—Validation of Isolator Systems h1208i

(USP)

............................... 2162

Sterilization and Sterility Assurance of Compendial Articles

h1211i (USP)

........................... 1729

Tablet Friability h1216i (USP) .................. 1740

Terminally Sterilized Pharmaceutical Products—Parametric

Release h1222i (USP)

...................... 1741

Total Organic Carbon h643i (USP) ............... 1700

Uniformity of Dosage Units h905i (USP) ........... 1474

USP Reference Standards h11i (USP) .............. 31, 211,

416, 613, 785, 998, 1150, 1338, 1565, 1674, 1969, 2092

USP Reference Standards h11i (USP erratum) ......... 33

Validation of Compendial Methods h1225i (USP) ....... 1380

Vitamin A Assay h571i (USP) .................. 1340

Water Conductivity h645i (USP) .................233, 1379

Water for Health Applications h1230i (USP) .......... 1387

Water for Pharmaceutical Purposes h1231i (USP) ....... 1744

Weights and Balances h41i (USP) ................ 999

Written Prescription Drug Information—Guidelines h1265i

(USP)

............................... 999

REAGENTS, INDIC ATORS, AND SOLUTIONS

Reagent Speciﬁcations

Acetal (USP)

.......................... 644

Ammonium Hydroxide, 6N (USP) .............. 1388

Ammonium pyrrolidinedithiocarbamate (USP) ....... 1043

Anion-exchange Resin, Styrene-Divinylbenzene (USP) .. 1043

Bacterial Alkaline Protease Preparation (USP) ....... 644

Benzamidine Hydrochloride Hydrate (USP) ........ 644

Bromoﬂuoromethane (USP) .................. 1388

Calf Thymus DNA (USP) ................... 1389

Cation-exchange Resin, Styrene-Divinylbenzene (USP) .. 1043

4-Chlorophenol (USP) .....................1044, 2168

p-Chlorophenol (USP) ..................... 1045

Chromotrope 2R (USP) .................... 1389

Citric Acid (USP) ....................... 1044

Citric Acid, Anhydrous (USP) ................ 1044

Collagen (USP) ......................... 1389

Collagenase (USP) ....................... 1389

Bovine Collagen (USP) .................... 644

Rat Tail Collagen (USP) .................... 644

Cyclohexylmethanol (USP) .................. 644

2,8-Dichlorodibenzo-p-dioxin (USP) ............. 2168

2,8-Dichlorodibenzofuran (USP) ............... 2168

2,4-Dichlorophenol (USP) ................... 2168

Dicyclohexyl (USP) ...................... 645

1,5-Dimethyl-1,5-diazaundecamethylene Polymethobromide

(USP)

............................. 315

1,9-Dimethyl-Methylene Blue (USP) ............ 645

Dimethyl Sulfoxide (USP) ................... 1045

Direct Red 80 (USP) ...................... 1390

3-(Dodecyldimethylammonio)propanesulfonate (USP) ... 645

Ether, Peroxide-Free (USP) .................. 1390

Ethylbenzene (USP) ...................... 645

Fast Green FCF (USP) ..................... 1390

Fibroblast Growth Factor-2 (USP) .............. 645

Heptakis-(2,6-di-O-methyl)--cyclodextrin (USP) ..... 2169

Hexanes (USP) ......................... 1046

Hexane, Solvent (USP) .................... 1045

Hexane, Solvent, Chromatographic (USP) .......... 1046

2’-(4-Hydroxyphenyl)-5-(4-methyl-1-piperazinyl)-2,5’-bi-1H-

benzimidazole trihydrochloride pentahydrate (USP)

... 1388

Iodine (USP) .......................... 1390

Isovaleric Acid (USP) ..................... 1046

Lauryl Dimethyl Amine Oxide (USP) ............ 645

Methanol, Aldehyde-Free (USP) ............... 646

Methoxyphenylacetic Acid (USP) .............. 1046

Methylbenzothiazolone Hydrazone Hydrochloride

(USP)

............................. 646

Methyl Carbamate (USP erratum) .............. 33

Methylene Blue (USP) ..................... 1390

Methyl Iodide (USP) ...................... 1046

4-Methylpentan-2-ol (USP) .................. 646

Methyl Sulfoxide (USP) .................... 1047

Nonionic Wetting Agent (USP) ................ 1047

Octoxynol 9 (USP) ....................... 1391

Oxygen-Helium Certiﬁed Standard (USP) .......... 646

Phenylmethylsulfonyl Fluoride (USP) ............ 647

Piperazine (USP) ........................ 1821

Propionaldehyde (USP) .................... 647

Rhodamine 6G (USP) ..................... 1391

Sodium 1-Heptanesulfonate (USP) ..............315, 1047

Sodium 1-Heptanesulfonate Monohydrate (USP) ...... 647

Sodium 1-Hexanesulfonate (USP) ..............315, 1048

Sodium Phosphate, Monobasic (USP) ............ 1391

Thyroglobulin (USP) ...................... 316

1,3,7-Trichlorodibenzo-p-dioxin (USP) ...........1388, 2169

2,4,8-Trichlorodibenzofuran (USP) .............. 2169

Tritirachium Album Proteinase K (USP) ........... 647

Tropic Acid (USP) ....................... 1048

Tropine (USP) ......................... 647

Vinyl Acetate (USP) ...................... 2169

Wright’s Stain (USP) ...................... 316

Reagents, Indicators, and Solutions (USP erratum) ...... 417

Test Solutions (USP) .......................316, 1391

Cupric Citrate TS ........................316, 1391

Ferroin TS ............................316, 1391

Folin-Ciocalteu Phenol TS ..................316, 1391

Hydroxylamine HydrochlorIde TS ..............316, 1391

Methyl Yellow TS .......................316, 1391

Nickel Standard Solution TS .................316, 1391

Perchloric Acid TS .......................316, 1391

Volumetric Solutions .......................1392, 2170

Ammonium Thiocyanate, Tenth-Normal (0.1 N) (USP) ..1393, 2170

Bromine, Tenth-Normal (0.1 N) (USP) ...........1393, 2170

Ceric Ammonium Nitrate, Twentieth-Normal (0.05 N)

(USP)

.............................1394, 2170

Ceric Sulfate, Tenth-Normal (0.1 N) (USP) .........1394, 2170

Cupric Nitrate, Tenth Normal (0.1 N) (USP) ........1394, 2171

Standard Dichlorophenol-Indophenol Solution (USP) ...1394, 2171

Pharmacopeial Forum

2326

INDEX Vol. 30(6) [Nov.–Dec. 2004]

Index

Edetate Disodium, Twentieth-Molar (0.05 M) (USP) ...1395, 2171

Ferric Ammonium Sulfate, Tenth-Normal (0.1 N)

(USP)

.............................1395, 2172

Ferrous Ammonium Sulfate, Tenth-Normal (0.1 N)

(USP)

.............................1395, 2172

Hydrochloric Acid, Normal (1 N) (USP) ..........1395, 2172

Hydrochloric Acid, Half-Normal (0.5 N) (USP) ......1395, 2172

Hydrochloric Acid, Half-Normal (0.5 N) in Methanol

(USP)

.............................1396, 2172

Hydrochloric Acid, Alcoholic, Tenth-Molar (0.1 M)

(USP)

.............................1396, 2173

Iodine, Tenth-Normal (0.1 N) (USP) .............1396, 2173

Iodine, Hundredth-Normal (0.01 N) (USP) .........1396, 2173

Lead Perchlorate, Tenth-Molar (0.1 M) (USP) .......1048, 1396, 2173

Lead Perchlorate, Hundredth-Molar (0.01 M) (USP) ....1397, 2173

Lithium Methoxide, Fiftieth-Normal (0.02 N) in Methanol

(USP)

.............................1397, 2174

Lithium Methoxide, Tenth-Normal (0.1 N) in Toluene

(USP)

.............................1397, 2174

Lithium Methoxide, Tenth-Normal (0.1 N) in Chlorobenzene

(USP)

.............................1397, 2174

Mercuric Nitrate, Tenth-Molar (0.1 M) (USP) .......1398, 2174

Morpholine, Half-Normal (0.5 N) in Methanol (USP) ...1398, 2174

Oxalic Acid, Tenth-Normal (0.1 N) (USP) .........1398, 2174

Perchloric Acid, Tenth-Normal (0.1 N) (in Glacial Acetic

Acid) (USP)

.........................1398, 2175

Perchloric Acid, Tenth-Normal (0.1 N) in Dioxane

(USP)

.............................1398, 2175

Potassium Bromate, Tenth-Normal (0.1 N) (USP) .....1399, 2175

Potassium Bromide-Bromate, Tenth-Normal (0.1 N)

(USP)

.............................1399, 2175

Potassium Dichromate, Tenth-Normal (0.1 N) (USP) ...1399, 2176

Potassium Ferricyanide, Twentieth-Molar (0.05 M)

(USP)

.............................1399, 2176

Potassium Hydroxide, Normal (1 N) (USP) .........1399, 2176

Potassium Hydroxide, Alcoholic, Half-Normal (0.5 N)

(USP)

.............................1399, 2176

Potassium Hydroxide, Alcoholic, Tenth-Molar (0.1 M)

(USP)

.............................1400, 2176

Potassium Hydroxide, Methanolic, Tenth-Normal (0.1 N)

(USP)

.............................1400, 2176

Potassium Permanganate, Tenth-Normal (0.1 N)

(USP)

.............................1400, 2177

Silver Nitrate, Tenth-Normal (0.1 N) (USP) .........1400, 2177

Sodium Hydroxide, Normal (1 N) (USP) ..........1400, 2177

Sodium Hydroxide, Alcoholic, Tenth-Normal (0.1 N)

(USP)

.............................1401, 2177

Sodium Methoxide, Tenth-Normal (0.1 N) (in Toluene)

(USP)

.............................1401, 2178

Sodium Methoxide, Half-Normal (0.5 N) in Methanol

(USP)

.............................1401, 2178

Sodium Nitrite, Tenth-Molar (0.1 M) (USP) ........1401, 2178

Sodium Tetraphenylboron, Fiftieth-Molar (0.02 M)

(USP)

.............................1402, 2178

Sodium Thiosulfate, Tenth-Normal (0.1 N) (USP) .....1402, 2179

Sulfuric Acid, Half-Normal (0.5 N) in Alcohol (USP) ...1402, 2179

Tetrabutylammonium Hydroxide, Tenth-Normal (0.1 N)

(USP)

.............................1402, 2179

Tetrabutylammonium Hydroxide in Methanol/Isopropyl

Alcohol, 0.1 N (USP)

....................1403, 2179

Tetramethylammonium Bromide, Tenth-Molar (0.1 M)

(USP)

.............................1403, 2180

Tetramethylammonium Chloride, Tenth-Molar (0.1 M)

(USP)

.............................1403, 2180

Titanium Trichloride, Tenth-Normal (0.1 N) (USP) ....1403, 2180

Zinc Sulfate, Twentieth-Molar (0.05 M) (USP) .......1403, 2180

Reagent Footnotes ........................ 316, 647

REFERENCE TABLES

Alcoholmetric Table (USP erratum) ............... 33

Container Speciﬁcations for Capsules and Tablets

(USP)

...............................648, 1403, 1821, 2181

Description and Relative Solubility of USP and NF Articles

(USP)

...............................317, 650, 1050, 1404, 1822, 2183

Description and Relative Solubility of USP and NF Articles

(USP erratum)

.......................... 33

GENERAL SUBJECTS

Canceled Revision Proposals ...................331, 665, 1064, 1419, 1836, 2201

Chromatographic Reagents Now

Available

.............................21, 403, 778, 1135, 1553, 1960

Dietary Supplements–Monographs ...............197, 546, 950, 1664, 2068

Errata List for USP 27–NF 22

Alclometasone Dipropionate Ointment

........... 787

Alcoholometric Table ..................... 33

Bethanechol Chloride ..................... 1155

Bisoprolol Fumarate ...................... 417

Bisoprolol Fumarate and Hydrochlorothiazide Tablets ... 1155

Calcium Carbonate, Magnesia, and Simethicone Tablets . 787

Cefonicid Sodium ....................... 787

Cefuroxime Axetil for Oral Suspension ........... 417

Powdered Cellulose ...................... 787

Ciproﬂoxacin .......................... 33

Description and Relative Solubility of USP and

NF Articles

.......................... 33

Multiple Electrolytes and Dextrose Injection Type 2 .... 1566

Erythromycin Ethylsuccinate Tablets ............. 787

Famotidine ........................... 1566

Impurities in Ofﬁcial Articles h1086i ............ 787

Metrifonate ........................... 1155

Microbial Enumeration Tests—Nutritional and Dietary

Supplements h2021i

..................... 1566

Mitoxantrone Injection ..................... 1155

Narasin Granular ........................ 33

Octocrylene ........................... 1566

Optical Rotation h781i .................... 787

Potassium Chloride Extended-Release Tablets ....... 33

Powder Fineness h811i .................... 417

Procainamide Hydrochloride ................. 787

Reagent Speciﬁcations ..................... 33

Reagents, Indicators, and Solutions ............. 417

Sodium Cetostearyl Sulfate .................. 1566

Sotalol Hydrochloride ..................... 33

Tiamulin Fumarate ....................... 33

USP Reference Standards h11i ................ 33

Water for Hemodialysis .................... 1566

Fifth Interim Revision Announcement ............. 1559

First Interim Revision Announcement .............. 25

Fourth Interim Revision Announcement ............ 1141

Harmonization

Alcohol (USP)

.........................669, 1843

Dehydrated Alcohol (USP) ..................673, 1847

Benzyl Alcohol (NF) ...................... 690

Butylparaben (NF) ....................... 1431

Carboxymethylcellulose Calcium (NF) ........... 695

Cellacefate (NF) ........................ 697

Cellulose Acetate (NF) ..................... 699

Microcrystalline Cellulose (NF) ............... 1433

Powdered Cellulose (NF) ................... 1437

Citric Acid (USP) ....................... 677

Anhydrous Citric Acid (USP) .................677, 1851

Citric Acid Monohydrate (USP) ...............681, 1854

Croscarmellose Sodium (NF) .................702, 1439

Ethylcellulose (NF) ....................... 706

Ethylparaben (NF) ....................... 1443

Hydroxyethyl Cellulose (NF) ................. 709

Hydroxypropyl Cellulose (NF) ................ 335

Low-Substituted Hydroxypropyl Cellulose (NF) ...... 338

Pharmacopeial Forum

Vol. 30(6) [Nov.–Dec. 2004]

INDEX 2327

Index

Magnesium Stearate (NF) ................... 340

Methylparaben (NF) ...................... 1445

Optical Microscopy h776i (USP) ............... 2209

Particle Size Distribution Estimation by Analytical Sieving

h786i (USP)

.........................2216, 2219

Powder Flow h1174i (USP) .................. 2226

Propylparaben (NF) ...................... 1448

Saccharin (NF) ......................... 1450

Saccharin Calcium (USP) ................... 1423

Saccharin Sodium (USP) ................... 1427

Sodium Chloride (USP) .................... 685

Sodium Starch Glycolate (NF) ................ 1454

Speciﬁc Surface Area h846i (USP) .............. 1465

Starch (NF) ........................... 714

Corn Starch (NF) ........................715, 1457, 1862

Potato Starch (USP) ......................718, 1460, 1865

Rice Starch (NF) ........................ 721

Wheat Starch (USP) ......................723, 1462, 1868

Talc (USP) ........................... 1857

Uniformity of Dosage Units h905i (USP) .......... 1474

How to Submit Comments ....................21, 404, 778, 1136, 1553, 1960

How to Use PF ...........................11, 393, 767, 1125, 1543, 1949

In-Process Revision ........................35, 419, 789, 1157, 1567, 1971

Interim Revision Announcement

First

............................... 25

Second .............................. 407

Third ............................... 783

Fourth .............................. 1141

Fifth ............................... 1559

Sixth ............................... 1965

International Correspondence ...................21, 404, 778, 1135, 1553, 1960

Nomenclature ...........................370, 741, 1097, 1514, 1923, 2305

Notice of Revision Pertaining to the Packaging and Storage

Statements for Excipient Articles

............... 402, 776

Pharmacopeial Education

Courses

..............................20, 402, 777, 1134, 1552, 1959

Pharmacopeial Previews .....................347, 729, 1069, 1487, 1871, 2233

Plasma Spectrochemistry ..................... 776

Policies and Announcements

Chromatographic Reagents Now

Available

...........................21, 403, 778, 1135, 1553, 1960

How to Submit Comments ..................21, 404, 778, 1136, 1553, 1960

In Memoriam—Leonard C. Bailey, Ph.D. .......... 1958

International Correspondence .................21, 404, 778, 1135, 1553, 1960

Notice of Revision Pertaining to the Packaging and Storage

Statements for Excipient Articles

............. 402, 776

Pharmacopeial Education

Courses

............................20, 402, 777, 1134, 1552, 1959

Plasma Spectrochemistry ................... 776

USAN Council Secretariat Revises USAN Fee-for-Service

Charges

............................776, 1134, 1552, 1959

USP Guideline for Submitting Requests for Revision to the

USP–NF

...........................20, 402, 777, 1134, 1552, 1959

USP–NF Available in Three

Electronic Formats

.....................21, 403, 778, 1135, 1553, 1959

USP to Hold First Annual Scientiﬁc Meeting ........776, 1134, 1552

Visit the USP Web Site at

hhttp://www.usp.orgi

....................21, 403, 778, 1135, 1553, 1959

Previous PF Proposals Still

Pending

..............................319, 652, 1052, 1407, 1824, 2189

Second Interim Revision Announcement ............ 407

Sixth Interim Revision Announcement ............. 1963

Standards Development ......................7, 389, 763, 1121, 1539, 1945

Stimuli to the Revision Process

Changes to USP Heavy Metals h231i, Geary, John T.

... 1876

Determination of the Hydroxypropoxy Content in

Hydroxypropyl Cellulose by

H NMR, Andersson, T.;

Erickson, M. and Richardson, S.

............. 1498

Development of a New Ofﬁcial Compendium, Separate from

USP–NF, for Articles Not Legally Marketed in the U.S.,

Council of Experts Executive Committee, Ad Hoc Council

of Experts, and USP Staff

................. 1877

Examination of Selection of Light-Scattering and Light-

Obscuration Acceptance Criteria for Lipid Injectable

Emulsions, Driscoll, David F.

............... 2244

The FDA Process Analytical Technology (PAT)

Initiative—An Alternative Pharmaceutical manufacturing

Practice (aPMP), Walter Dziki, Zhijun Jiang, David A.

Radspinner, Michael Miller, Roger Deschenes, Paul

Newby, Jeanne Moldenhauer, Claude Anger, Scott Sutton,

Tony Cundell, Patrick McCarthy, Amy McDaniel, Stacy

Montgomery, Claudio Denoya, Emil W. Ciurczak, and

Gary E. Ritchie

....................... 2254

The Impact of Multiple-Unit Desiccating Containers for

Prescription Packaging, Peter Sagona, Jon Freedman,

William Spano, and Robert Pangborn, Ph.D

....... 2265

Improving Sensitivity and Robustness of Chromatographic

Assays for Netilmicin, Cao, Yaqi; Cheng, Jun; Jandik, Petr

and Mou, Shifen

....................... 1501

Inductively Coupled Plasma–Optical Emission Spectroscopy

as an Alternative to the Heavy Metals Test,

Schenkenberger, Martha and Lewen, Nancy

....... 2271

Instructions to Authors .....................367, 739, 1083, 1497, 1875, 2243

Manufacturer’s Market Containers and Closures Study II;

Proposed Revisions to h671i Containers—Permeation,

Taborsky, C. Jeanne

..................... 1508

Microbial Identiﬁcation in the Pharmaceutical Industry,

Cundell, Anthony M. and Sutton, Scott V.W.

...... 1884

Particulate Contaminents of Intravenous Medication and the

Limits Set by USP General Chapter h788i, Nrapendra Nath,

Elizabeth McNeal, Donald Obenhuber, Branda Pillari, Lisa

Shelton, Marla Stevens-Riley, and Neal Sweeney,

Microbiology Team, Ofﬁce of Generic Drugs, U.S. Food

and Drug Administration

.................. 2272

Pepsin and Pancreatin Performance in the Dissolution of

Crosslinked Gelatin Capsules from pH 1 to 8, Gallery, Jean;

Han, Jian-Hwa and Abraham, Chiramel

......... 1084

A Rapid and Simple Stability-Indicating HPLC Method for

the Analysis of Valproic Acid in Divalproex Sodium

Formulations, Yat, Patrick N.; Odidi, Isa; Odidi, Amina;

Varatharajan, Raman; Zhang, Shicheng; Pourhadi, Fariba;

and Fayaiz, Ahmed

..................... 2281

Signiﬁcant Digits and Rounding, L. Torbeck ........ 1090

Veterinary Application of In Vitro Dissolution Data and the

Biopharmaceutics Classiﬁcation System, Marilyn N.

Martinez, Mark G. Papich, and Jim E. Riviere

...... 2295

Pharmacopeial Forum

2328

INDEX Vol. 30(6) [Nov.–Dec. 2004]

Index

[Note—This index covers Vol. 31 No. 1, pp. 1–288, Vol. 31,

No. 2, pp. 289–669, Vol. 31, No. 3, pp. 671–980, Vol. 31,

No. 4, pp. 981–1287, Vol. 31, No. 5, pp. 1289–1556, Vol. 31,

No. 6, pp. 1557-1773]

GENERAL NOTICES AND REQUIREMENTS

Tests and Assays (USP) ...................... 718

Preservation, Packaging, Storage, and Labeling (USP) .... 721

MONOGRAPHS

Acesulfame Potassium (NF) ................... 87, 811

Acetaminophen (USP) ...................... 1024

Acetazolamide Oral Suspension (USP) ............. 917

Acetylcysteine (USP) ....................... 726

Ademetionine Disulfate Tosylate (USP) ............ 469

Adipic Acid (NF) ......................... 87

Medical Air (USP) ......................... 1024

Albumin Human (USP) ...................... 1338

Albuterol Tablets (USP) ...................... 40, 726

Alendronate Sodium (USP) .................... 1344

Alprazolam Oral Suspension (USP) ............... 918

Amantadine Hydrochloride (USP) ................ 1344

Amiloride Hydrochloride and Hydrochlorothiazide Tablets

(USP)

............................... 1025

Aminocaproic Acid (USP erratum) ...............373, 1333

Amino Methacrylate Copolymer (NF) ............. 1137

Amitriptyline Hydrochloride (USP) ............... 1606

Ammonio Methacrylate Copolymer Dispersion (NF) ..... 483

Amoxicillin and Clavulanate Potassium for Oral Suspension

(USP)

............................... 1026

Amphetamine Sulfate (USP) ................... 381

Anticoagulant Citrate Dextrose Solution (USP) ........ 727

Anticoagulant Citrate Phosphate Dextrose Solution (USP) .. 730

Anticoagulant Citrate Phosphate Dextrose Adenine Solution

(USP)

............................... 728

Anticoagulant Sodium Citrate Solution (USP) ......... 731

Aprotinin (USP) .......................... 732

Aprotinin Injection (USP) .................... 736

Asparagine (NF) .......................... 87

Aspartic Acid (USP) ........................ 1345

Aspirin Boluses (USP) ...................... 1026

Aspirin Delayed-Release Capsules (USP) ............ 140, 319

Aspirin Delayed-Release Tablets (USP) ............. 141, 319

Aspirin Extended-Release Tablets (USP) ............ 141, 319

Atenolol (USP) ........................... 1345

Azathioprine Oral Suspension (USP) .............. 920

Azithromycin (USP erratum) ................... 1333

Aztreonam for Injection (USP) .................. 737

Baclofen Oral Solution (USP) .................. 921

Benazepril Hydrochloride (USP) ................. 1027

Puriﬁed Bentonite (NF) ...................... 483

Betamethasone Acetate (USP) .................. 381

Betamethasone Oral Solution (USP) ............... 1032

Bethanechol Chloride Oral Suspension (USP) ......... 923

Bicalutamide (USP) ........................ 738

Biphasic Isophane Insulin Human Suspension (USP) ..... 1032

Bismuth Subsalicylate Oral Suspension (USP) ......... 1035

Bismuth Subsalicylate Tablets (USP) .............. 741

Bisoprolol Fumarate Tablets (USP) ............... 30

Bisoprolol Fumarate Tablets (USP erratum) .......... 1601

Bromocriptine Mesylate (USP) .................. 1346

Bupropion Hydrochloride (USP) ................. 381

Bupropion Hydrochloride Extended-Release Tablets

(USP)

...............................142, 319, 384

Bupropion Hydrochloride Extended-Release Tablets

(USP erratum)

.......................... 373

Buspirone Hydrochloride (USP) ................. 742

Butabarbital Sodium Tablets (USP) ............... 41, 709

Butorphanol Tartrate Nasal Solution (USP) ........... 1346

Butylparaben (NF) ......................... 190

Calcitonin Salmon (USP) .....................385, 1036

Calcium Lactate (USP) ...................... 1608

Calcium Lactate Tablets (USP) .................. 1609

Calcium Silicate (NF) ....................... 1417

Camphor (USP) .......................... 742

Canola Oil (NF) .......................... 1675

Captopril Oral Suspension (USP) ................ 924

Carbamazepine Tablets (USP) ..................143, 320, 1044

Carbamazepine Extended-Release Tablets (USP) ....... 143, 321

Carbomer 934 (NF) ........................ 484

Carbomer 934P (NF) ....................... 484

Carbomer 940 (NF) ........................ 485

Carbomer 941 (NF) ........................ 485

Carbomer 1342 (NF) ....................... 485

Carbomer Copolymer (NF) .................... 486

Carbomer Homopolymer (NF) .................. 488

Carbomer Interpolymer (NF) ................... 493

Carbon Dioxide (USP) ...................... 1045

Carboxymethylcellulose Calcium (NF) ............. 1420

Carboxymethylcellulose Sodium (USP) ............. 1349

Carboxymethylcellulose Sodium 12 (NF) ............1139, 1420

Carboxymethylcellulose Sodium Paste (USP) ......... 1349

Cefaclor Extended-Release Tablets (USP) ...........42, 144, 321

Cefadroxil for Oral Suspension (USP) ............. 1045

Ceftazidime for Injection (USP erratum) ............ 373

Cellaburate (NF) .......................... 1420

Microcrystalline Cellulose (NF) .................1139, 1421

Powdered Cellulose (NF) ..................... 1421

Cetostearyl Alcohol (NF) ..................... 494

Cetyl Alcohol (NF) ........................ 494

Chlorpheniramine Maleate Extended-Release Capsules

(USP)

............................... 144, 321

Chlorpheniramine Maleate and Phenylpropanolamine

Hydrochloride Extended-Release Capsules (USP)

...... 145, 322

Chlorpheniramine Maleate and Phenylpropanolamine

Hydrochloride Extended-Release Tablets (USP)

....... 145, 322

Chlorpheniramine Maleate and Pseudoephedrine

Hydrochloride Extended-Release Capsules (USP)

...... 145, 322

Cholecalciferol Solution (USP erratum) ............. 35

Cholestyramine Resin (USP erratum) .............. 373

Choline Chloride (USP) ...................... 84

Chondroitin Sulfate Sodium Tablets (USP) ........... 85, 709

Ciproﬂoxacin (USP) ........................ 393

Ciproﬂoxacin Injection (USP) .................. 42, 393

Ciproﬂoxacin Oral Solution (USP) ............... 925

Citalopram Hydrobromide (USP) ................ 742

Citalopram Tablets (USP) .....................745, 1046

Anhydrous Citric Acid (USP) ..................607, 749, 1016

Citric Acid Monohydrate (USP) .................607, 750, 1016

Citric Acid, Magnesium Oxide, and Sodium Carbonate

Irrigation (USP)

......................... 394

Cladribine (USP) ..........................395, 1609

Clarithromycin Extended-Release Tablets (USP) ....... 1016

Clavulanate Potassium (USP erratum) .............. 373

Clindamycin Hydrochloride Oral Solution (USP) ....... 1350

Clonazepam Oral Suspension (USP) .............. 927

Clonidine Transdermal System (USP) .............. 146, 323

Clonidine Transdermal System (USP erratum) ......... 373

Clotrimazole Lozenges (USP) .................. 398

Cloxacillin Benzathine (USP) .................. 1050

Cloxacillin Benzathine Intramammary Infusion (USP) .... 1051

Cyanocobalamin (USP) ...................... 1350

Cyclomethicone (NF) ....................... 1140

Cyclopropane (USP) ........................ 1052

Dapsone (USP) ........................... 750

Desmopressin Acetate (USP) ................... 1052

Desmopressin Injection (USP) .................. 1057

Desmopressin Nasal Spray Solution (USP) ........... 1059

Diazepam Extended-Release Capsules (USP) ......... 147, 323

Dibucaine (USP) .......................... 399

Dibucaine Cream (USP) ..................... 399

Pharmacopeial Forum

1766

INDEX Vol. 31(6) [Nov.–Dec. 2005]

Index

Dibucaine Ointment (USP) .................... 400

Dibucaine Hydrochloride (USP) ................. 400

Dibucaine Hydrochloride Injection (USP) ........... 401

Dibutyl Sebacate (NF) ...................... 1140

Diclofenac Potassium (USP) ................... 1350

Diclofenac Potassium Tablets (USP) .............. 1352

Diclofenac Sodium Delayed-Release Tablets (USP) ......148, 324, 751

Diclofenac Sodium Delayed-Release Tablets

(USP erratum)

.......................... 1601

Didanosine (USP) ......................... 1355

Didanosine for Oral Solution (USP) ............... 1357

Didanosine Tablets (USP) .................... 1359

Diethanolamine (NF) ....................... 1422

Digitalis (USP erratum) ...................... 373

Digoxin Oral Solution (USP) ................... 1361

Diisopropanolamine (NF) ..................... 1140

Diltiazem Hydrochloride Extended-Release Capsules

(USP)

............................... 148, 324

Diltiazem Hydrochloride Oral Suspension (USP) ....... 928

Diphenoxylate Hydrochloride and Atropine Sulfate Oral

Solution (USP)

.......................... 1612

Diphenoxylate Hydrochloride and Atropine Sulfate Tablets

(USP)

............................... 1614

Diphtheria Toxin for Schick Test (USP) ............ 1616

Dipyridamole Oral Suspension (USP) .............. 930

Dirithromycin Delayed-Release Tablets (USP) ......... 151, 327

Disopyramide Phosphate Extended-Release Capsules

(USP)

............................... 152, 327

Divalproex Sodium (USP) .................... 1362

Divalproex Sodium Delayed-Release Tablets (USP) ..... 153, 328

Docusate Calcium (USP) ..................... 752

Docusate Potassium (USP) .................... 753

Docusate Sodium (USP) ..................... 753

Dolasetron Mesylate Oral Suspension (USP) .......... 931

Dorzolamide Hydrochloride (USP) ............... 401

Doxycycline Hyclate Delayed-Release Capsules (USP) .... 154, 328

Drospirenone (USP) ........................ 754

Dyclonine Hydrochloride (USP) ................. 42

Egg Phospholipids (USP) ..................... 757

Multiple Electrolytes Injection Type 2 (USP) ......... 759

Multiple Electrolytes and Dextrose Injection Type 2

(USP)

............................... 760

Trace Elements Injection (USP erratum) ............ 373

Enoxaparin Sodium Injection (USP) ............... 761

Ensulizole (USP) ..........................1363, 1617

Epinephrine Injection (USP) ................... 43

Erythritol (NF) ........................... 1422

Erythromycin Delayed-Release Capsules (USP) ........ 154, 328

Erythromycin Delayed-Release Tablets (USP) ......... 154, 329

Erythromycin Ointment (USP erratum) ............. 373

Estradiol and Norethindrone Acetate Tablets (USP) ...... 1364

Estradiol Transdermal System (USP) .............. 1063

Estradiol Vaginal Tablets (USP) ................. 1617

Synthetic Conjugated Estrogens (USP) ............. 1620

Conjugated Estrogens Tablets (USP) .............. 155, 329

Ethinyl Estradiol Tablets (USP) .................402, 1067

Ethyl Acrylate and Methyl Methacrylate Copolymer

Dispersion (NF)

......................... 1141

Ethylcellulose Aqueous Dispersion (NF) ............811, 1676

Ethyl Chloride (USP) ....................... 1368

Ethylparaben (NF) ......................... 812

Etidronate Disodium (USP) .................... 1625

Etodolac Extended-Release Tablets (USP) ...........1068, 1330

Felodipine Extended-Release Tablets (USP) .......... 156, 330

Fenoﬁbrate (USP) ......................... 763

Fentanyl (USP) ........................... 1626

Ferric Oxide (NF) ......................... 88, 710

Ferrous Fumarate and Docusate Sodium Extended-Release

Tablets (USP)

.......................... 158, 332

Fexofenadine Hydrochloride (USP) ............... 703

Fexofenadine Hydrochloride Capsules (USP) ......... 705

Fexofenadine Hydrochloride and Pseudoephedrine

Hydrochloride Extended-Release Tablets (USP)

....... 403

Fish Oil Rich in Omega-3 Acids (USP) ............. 474

Fish Oil Rich in Omega-3 Acids Capsules (USP) ....... 481

Fluconazole (USP) .........................408, 1368

Flucytosine Oral Suspension (USP) ............... 933

Flumazenil (USP) ......................... 1628

Fluorometholone Acetate (USP) ................. 1371

Flurazepam Hydrochloride (USP) ................ 766

Flurbiprofen (USP) ........................ 1069

Fluticasone Propionate (USP) .................. 1070

Fluticasone Propionate Nasal Spray (USP) ........... 1071

Fluvastatin Capsules (USP) .................... 47

Fluvastatin Sodium (USP) .................... 43

Gabapentin (USP) ......................... 50

Gadoteridol Injection (USP erratum) .............. 1333

Galactose (NF) ........................... 88

Gamma Cyclodextrin (NF) .................... 812

Ganciclovir Oral Solution (USP) ................. 934

Garlic Delayed-Release Tablets (USP) ............. 159, 332

Gemcitabine for Injection (USP) ................. 1630

Glipizide and Metformin Hydrochloride Tablets (USP) .... 1631

Glucagon (USP) .......................... 30, 1635

Glucosamine and Chondroitin Sulfate Sodium Tablets

(USP)

............................... 85, 709

Glutaral Concentrate (USP) .................... 766

Glyburide and Metformin Hydrochloride Tablets (USP) ... 766

Glyceryl Monostearate (NF) ...................495, 1677

Glycopyrrolate Tablets (USP) .................. 1077

Goserelin Acetate (USP) .....................410, 1637

Helium (USP) ...........................707, 1014, 1077

Hepatitis B Virus Vaccine Inactivated (USP) .......... 1641

Puriﬁed Honey (NF) ........................ 496

Hydroxypropyl Cellulose (NF) .................. 1425

Hydroxyzine Hydrochloride Tablets (USP) ........... 159, 332

Hyoscyamine Sulfate Elixir (USP) ................ 1372

Hyoscyamine Sulfate Injection (USP) .............. 1373

Hyoscyamine Sulfate Oral Solution (USP) ........... 1373

Hyoscyamine Sulfate Tablets (USP) ............... 1374

Hyoscyamine Sulfate (USP) ................... 1078

Hypromellose Ophthalmic Solution (USP) ........... 771

Ibuprofen Tablets (USP) ..................... 1374

Indomethacin Extended-Release Capsules (USP) .......159, 332

Insulin (USP) ............................ 1375

Insulin Human (USP) ....................... 1375

Sodium Iodide I 123 Capsules (USP) .............. 1642

Sodium Iodide I 123 Solution (USP) .............. 1642

Sodium Iodide I 131 Solution (USP) .............. 1643

Iodixanol (USP) .......................... 54

Irbesartan Tablets (USP) ..................... 1080

Isobutane (NF) ........................... 1425

Isomalt (NF) ............................ 88

Isopropyl Alcohol (USP) ..................... 1375

Isosorbide Dinitrate Extended-Release Capsules (USP) .... 160, 333

Isosorbide Dinitrate Tablets (USP) ................ 1375

Isosorbide Dinitrate Chewable Tablets (USP) ......... 1376

Isosorbide Dinitrate Extended-Release Tablets

(USP)

...............................161, 333, 1376

Isosorbide Dinitrate Sublingual Tablets (USP) ......... 1377

Diluted Isosorbide Mononitrate (USP) .............1060, 1643

Isosorbide Mononitrate Extended-Release Tablets (USP) ... 1082

Isradipine Oral Solution (USP) .................. 936

Ivermectin (USP) ......................... 1645

Ketoprofen (USP) ......................... 772

Ketoprofen Extended-Release Capsules (USP) ......... 1378

Labetalol Hydrochloride Oral Suspension (USP) ....... 937

Lactitol (NF) ............................ 1143

Lansoprazole Delayed-Release Capsules (USP) ........ 161, 334

Lauroyl Polyoxylglycerides (NF) ................ 92

Leﬂunomide (USP) ........................ 1380

Leﬂunomide Tablets (USP) .................... 1383

Pharmacopeial Forum

Vol. 31(6) [Nov.–Dec. 2005]

INDEX 1767

Index

Levocabastine Hydrochloride (USP) .............. 1647

Levothyroxine Sodium Oral Solution (USP) .......... 938

Levothyroxine Sodium Tablets (USP) ..............55, 413, 709

Lidocaine Hydrochloride (USP) ................. 415

Lidocaine Hydrochloride and Epinephrine Injection (USP) .. 415

Lidocaine and Prilocaine Cream (USP) ............. 1087

Lindane (USP) ........................... 1648

Liothyronine Sodium Tablets (USP) ............... 162, 334

Lipid Injectable Emulsion (USP) ................ 416

Lisinopril Tablets (USP) ..................... 1090

Lithium Carbonate Extended-Release Tablets

(USP)

...............................162, 335, 1385

Loratadine Oral Solution (USP) ................. 56

Lutein (USP) ............................ 1133

Lutein Preparation (USP) ..................... 1134

Magnesium Salicylate Tablets (USP erratum) ......... 1019

Magnesium Carbonate and Citric Acid for Oral Solution

(USP)

............................... 419

Magnesium Carbonate, Citric Acid, and Potassium Citrate

for Oral Solution (USP)

..................... 1386

Magnesium Chloride (USP) ................... 420

Magnesium Citrate Oral Solution (USP) ............ 420

Magnesium Citrate for Oral Solution (USP) .......... 421

Magnesium Oxide (USP) ..................... 1091

Maleic Acid (NF) ......................... 815

Maltitol (NF) ............................ 1143

Maltol (NF) ............................. 1425

Maltose (NF) ............................ 815

Mangafodipir Trisodium (USP) ................. 1650

Mecamylamine Hydrochloride (USP erratum) ......... 373

Meﬂoquine Hydrochloride (USP) ................422, 1091

Megestrol Acetate Oral Suspension (USP) ...........335, 1387

Meloxicam (USP) ......................... 57

Meperidine Hydrochloride (USP) ................ 62

Meropenem (USP erratum) .................... 35

Mesalamine (USP) ......................... 424

Mesalamine Extended-Release Capsules (USP) ........ 163, 336

Mesalamine Delayed-Release Tablets (USP) .......... 164, 337

Metformin Hydrochloride (USP) ................. 62, 1092

Metformin Hydrochloride Tablets (USP) ............ 1093

Metformin Hydrochloride Extended Release Tablets

(USP)

............................... 772

Methacrylic Acid Copolymer (NF) ............... 93

Methadone Hydrochloride Oral Solution (USP erratum) ... 1333

Methenamine Hippurate Tablets (USP) ............. 63

Methoxyﬂurane (USP) ...................... 1388

Methscopolamine Bromide (USP) ................ 425

Methscopolamine Bromide Tablets (USP) ........... 427

Methylcellulose Ophthalmic Solution (USP) .......... 780

Methylcellulose Oral Solution (USP) .............. 780

Methylcellulose Tablets (USP) .................. 780

Methylphenidate Hydrochloride Extended-Release Tablets

(USP)

............................... 164, 337

Metolazone Oral Suspension (USP) ............... 940

Metolazone Tablets (USP erratum) ............... 1333

Metoprolol Succinate Extended-Release Tablets (USP) .... 165, 337

Metoprolol Tartrate Oral Suspension (USP) .......... 941

Metronidazole Benzoate (USP) ................. 781

Miconazole Nitrate Vaginal Suppositories (USP) ....... 1389

Mirtazapine (USP) ......................... 1650

Monoethanolamine (NF) ..................... 1425

Morphine Sulfate Extended-Release Capsules (USP) ..... 165, 338

Mupirocin Calcium (USP) .................... 430

Mupirocin Cream (USP) ..................... 432

Nabumetone (USP) ........................ 63

Naphazoline Hydrochloride (USP) ................ 1093

Nefazodone Hydrochloride (USP) ................ 1094

Nefazodone Hydrochloride Tablets (USP) ........... 1096

Neotame (NF) ........................... 497

Nicotine Transdermal System (USP) .............. 166, 338

Nifedipine Extended-Release Tablets (USP) .......... 168, 340

Nitrofurantoin Capsules (USP) .................. 170, 342

Nitrogen (NF) ...........................708, 1015, 1145

Nitrogen 97 Percent (NF) .....................708, 1015, 1146

Nitrous Oxide (USP) .......................707, 1014, 1099

Norﬂoxacin Oral Suspension (USP) ............... 943

Norgestimate (USP) ........................ 1390

Oleyl Oleate (NF) ......................... 1678

Olive Oil (NF) ........................... 815

Omeprazole (USP) ......................... 1100

Omeprazole Delayed-Release Capsules (USP) .........171, 343, 1392

Ondansetron Hydrochloride Oral Suspension (USP) ..... 944

Ondansetron Injection (USP) ................... 1651

Ondansetron Orally Disintegrating Tablets (USP) ....... 1101

Orphenadrine Citrate Injection (USP) .............. 1651

Oxandrolone (USP) ........................ 64

Oxandrolone Tablets (USP) ....................67, 344, 781, 1330

Oxprenolol Hydrochloride Extended-Release Tablets

(USP)

............................... 173, 345

Oxtriphylline Extended-Release Tablets (USP) ........ 174, 345

Oxybutynin Chloride Extended-Release Tablets (USP) .... 1652

Oxycodone Hydrochloride Extended-Release Tablets

(USP)

............................... 1104

Oxygen (USP) ........................... 1107

Oxygen 93 Percent (USP) .................... 1107

Pamidronate Disodium (USP) .................. 1108

Pamidronate Disodium for Injection (USP) ........... 1111

Parafﬁn (NF) ............................ 1426

Paroxetine Hydrochloride (USP) ................. 69, 1112

Paroxetine Tablets (USP) ..................... 435

Pectin (USP) ............................ 783

Penicillamine Capsules (USP) .................. 436

Pentobarbital (USP) ........................ 72

Pentobarbital Sodium (USP) ................... 73

Pentoxifylline Extended-Release Tablets (USP) ........ 174, 345

Phenolsulfonphthalein (NF) ................... 94

Phenoxyethanol (NF) ....................... 94, 816

Phenylephrine Bitartrate (USP) ................. 783

Phenylpropanolamine Hydrochloride Extended-Release

Capsules (USP)

......................... 176, 347

Phenylpropanolamine Hydrochloride Extended-Release

Tablets (USP)

.......................... 177, 347

Pilocarpine Ocular System (USP) ................177, 348

Piperacillin and Tazobactam Injection (USP) .......... 437

Piperacillin and Tazobactam for Injection (USP) ........ 439

Polacrilin Potassium (NF) .................... 1679

Polyethylene Glycol (NF) ..................... 897

PEG 3350 and Electrolytes for Oral Solution (USP) ..... 1393

Polyethylene Oxide (NF) ..................... 95

Polyoxyl 10 Oleyl Ether (NF) .................. 816

Polyoxyl 20 Cetostearyl Ether (NF) ............... 817

Polyoxyl 35 Castor Oil (NF) ................... 1679

Potassium Alginate (NF) ..................... 1426

Potassium and Sodium Bicarbonates and Citric Acid

Effervescent Tablets for Oral Solution (USP)

........ 440

Potassium Bitartrate (USP) .................... 786

Potassium Bromide (USP) .................... 441

Potassium Citrate Extended-Release Tablets (USP) ...... 443

Potassium Citrate and Citric Acid Oral Solution (USP) .... 444

Potassium Iodide Oral Solution (USP) ............. 786

Potassium Sodium Tartrate (USP) ................ 787

Pravastatin Sodium (USP) .................... 1394

Prednicarbate (USP) ........................ 1398

Prednicarbate Cream (USP) ................... 1655

Prednicarbate Ointment (USP) .................. 1657

Procainamide Hydrochloride Extended-Release Tablets

(USP)

............................... 178, 348

Progesterone Intrauterine Contraceptive System (USP) .... 179, 349

Propofol (USP erratum) ...................... 1601

Propranolol Hydrochloride Extended-Release Capsules

(USP)

............................... 180, 350

Pharmacopeial Forum

1768

INDEX Vol. 31(6) [Nov.–Dec. 2005]

Index

Propranolol Hydrochloride and Hydrochlorothiazide

Extended-Release Capsules (USP)

...............181, 350

Propylene Glycol Dilaurate (NF) ................ 500

Propylene Glycol Monolaurate (NF) .............. 501

Pseudoephedrine Hydrochloride Extended-Release Capsules

(USP)

............................... 181, 351

Pseudoephedrine Hydrochloride Extended-Release Tablets

(USP)

............................... 182, 351

Quinidine Gluconate Extended-Release Tablets (USP) .... 183, 352

Quinidine Sulfate Oral Suspension (USP) ........... 946

Quinidine Sulfate Extended-Release Tablets (USP) ...... 184, 353

Ramipril (USP) .......................... 787

Oral Rehydration Salts (USP) ..................445, 1399

Risperidone (USP) ......................... 1659

Ritonavir (USP) .......................... 788

Rubella and Mumps Virus Vaccine Live (USP) ........ 1662

Saccharin (NF) ........................... 616

Saccharin Calcium (USP) ..................... 607

Saccharin Sodium (USP) .....................612, 1225

Saquinavir Mesylate (USP) .................... 1400

Schick Test Control (USP) .................... 1662

Scopolamine Hydrobromide (USP) ............... 73

Selenomethionine (USP) ..................... 482

Silicon Dioxide (NF) ....................... 1229

Colloidal Silicon Dioxide (NF) ................. 1232

Simvastatin (USP) ......................... 792

Sodium Benzoate (NF) ...................... 818

Sodium Bicarbonate (USP) .................... 795

Sodium Bicarbonate Injection (USP) .............. 1401

Sodium Bromide (USP) ...................... 446

Sodium Chloride (USP) ......................795, 1401

Sodium Citrate and Citric Acid Oral Solution (USP) ..... 797

Sodium Lactate Injection (USP) ................. 1402

Sodium Phosphates Rectal Solution (USP) ........... 1403

Sodium Polystyrene Sulfonate Suspension (USP) .......1115, 1331

Sodium Salicylate Tablets (USP) ................ 1116

Sodium Starch Glycolate (USP erratum) ............ 1019

Sodium Starch Glycolate (NF) .................. 1523

Sodium Sulﬁte (NF) ........................ 1146

Sodium Tartrate (NF) ....................... 95

Anhydrized Liquid Sorbitol (NF) ................ 1679

Spironolactone Tablets (USP) .................. 74

Pregelatinized Starch (NF erratum) ............... 373

Stavudine Capsules (USP) .................... 1403

Succinic Acid (NF) ........................ 95

Succinylcholine Chloride (USP) ................. 74, 1404

Sucralose (NF) ........................... 1146

Sucrose (NF) ............................ 902

Compressible Sugar (NF) ..................... 1147

Confectioner’s Sugar (NF) .................... 1147

Sugar Spheres (NF) ........................ 819

Sulfamethazine Granulated (USP) ................ 797

Sulfasalazine Delayed-Release Tablets (USP) .........185, 353

Sumatriptan Succinate Oral Suspension (USP) ......... 947

Sunﬂower Oil (NF) ........................ 95

Tagatose (NF) ........................... 819

Talc (USP) ............................. 1662

Tazobactam (USP) ......................... 1116

Technetium

99m

Tc Fanolesomab Injection (USP) ........448, 1405

Terazosin Hydrochloride (USP erratum) ............ 1019

Terbutaline Sulfate (USP) ..................... 75

Terbulatine Sulfate Inhalation Aerosol (USP) ......... 450

Terbutaline Sulfate Tablets (USP) ................ 76

Tetracaine Hydrochloride (USP) ................. 451

Tetraﬂuoroethane (NF) ...................... 1672

Thalidomide (USP) ........................ 452

Theophylline Extended-Release Capsules (USP) ....... 185, 354

Thioridazine Hydrochloride (USP) ............... 798

Thymol (NF) ............................ 821

Tiamulin (USP) .......................... 77

Tilmicosin (USP) ......................... 798

Tizanidine Hydrochloride (USP) ................. 452

Tizanidine Tablets (USP) ..................... 456

Tolazamide (USP) ......................... 1118

Tramadol Hydrochloride (USP) ................. 458

Tramadol Hydrochloride Tablets (USP) ............. 462

Travoprost (USP) ......................... 1119

Travoprost Ophthalmic Solution (USP) ............. 1121

Triamcinolone Acetonide (USP) ................. 800

Tricitrates Oral Solution (USP) ................. 465

Triclosan (USP) .......................... 1408

Medium-Chain Triglycerides (NF) ................ 98

Trihexyphenidyl Hydrochloride Extended-Release Capsules

(USP)

............................... 187, 355

Trimethoprim (USP) ........................ 1409

Trolamine (NF) .......................... 1427

Tryptophan (USP) ......................... 1410

Tylosin Tartrate (USP) ...................... 1410

Ubidecarenone (USP) ....................... 86

Ubidecarenone Capsules (USP) ................. 86

Ursodiol Capsules (USP) ..................... 79, 800

Valproic Acid Injection (USP) ..................801, 1412

Valsartan and Hydrochlorothiazide Tablets (USP) ....... 1123

Vasopressin (USP) ......................... 1127

Verapamil Hydrochloride Oral Suspension (USP) ....... 949

Verapamil Hydrochloride Extended-Release Tablets (USP) .. 188, 356

Vinorelbine Injection (USP) ...................1326, 1592

Water for Injection (USP) ..................... 466

Sterile Water for Inhalation (USP) ................ 802

Sterile Water for Injection (USP) ................ 803

Sterile Water for Irrigation (USP) ................ 804

Sterile Puriﬁed Water (USP) ................... 804

Puriﬁed Water (USP) ....................... 467

Pure Steam (USP) ......................... 467

Water for Hemodialysis (USP) .................. 468

Xanthan Gum (NF) ........................ 821

Xylitol (NF) ............................ 1147

Zinc Oxide (USP) ......................... 80

Zinc Oxide Neutral (USP) .................... 80

Zinc Sulfate Oral Solution (USP) ................ 468

Zinc Sulfate Tablets (USP) .................... 82

EXCIPIENTS

Excipients, USP and NF Excipients, Listed by Category

(NF)

................................805, 1128, 1414, 1672

GENERAL CHAPTERS

Alcohol Determination h611i (USP) ............... 823

Analytical Instrument Qualiﬁcation h1058i (USP) .......233, 1157, 1453

Assay for Citric Acid/Citrate and Phosphate h345i (USP) .. 514

Biotechnology-Derived Articles—Tests h1047i

(USP erratum)

.......................... 1333

Bulk Density and Tapped Density h616i (USP) ........ 909

Bulk Pharmaceutical Excipients—Certiﬁcate of Analysis

h1080i (USP)

........................... 1167

Chromatography h621i (USP) ..................825, 1681

Conductivity h644i (USP) .................... 841

Density of Solids h699i (USP) .................. 912

Disintegration h701i (USP) .................... 194, 358

Dissolution h711i (USP) .....................198, 360, 1691

The Dissolution Procedure: Development and Validation

h1092i (USP)

........................... 1463

Drug Product Interchangeability h1090i (USP) ........ 243

Drug Release h724i (USP) .................... 213, 367

Fats and Fixed Oils h401i (USP) ................ 1157

Globule Size Distribution in Lipid Injectable Emulsions

h729i (USP)

........................... 1448

Good Compounding Practices h1075i (USP) .......... 101

Heavy Metals h231i (USP) .................... 1435

Injections h1i (USP) ........................192, 504, 1149, 1328, 1428, 1599

Ion Chromatography h1065i (USP) ............... 519

Pharmacopeial Forum

Vol. 31(6) [Nov.–Dec. 2005]

INDEX 1769

Index

Light Diffraction Measurement of Particle Size

h429i (USP)

........................... 1234

Mass Spectrometry h736i (USP erratum) ............ 373

Microbiological Evaluation of Clean Rooms and Other

Controlled Environments h1116i (USP)

............ 524

Organic Volatile Impurities h467i (USP) ............ 1435

Osmolality and Osmolarity h785i (USP) ............ 845

Particulate Matter in Injections h788i (USP erratum) ..... 1601

Pharmaceutical Calculations in Prescription Compounding

h1160i (USP)

........................... 847

Pharmaceutical Calculations in Prescription Compounding

h1160i (USP erratum)

...................... 373

Porosimetry by Mercury Intrusion h267i (USP) ........ 905

Powder Fineness h811i (USP) .................. 228

Residue on Ignition h281i (USP) ................ 1526

Signiﬁcant Change Guide for Bulk Pharmaceutical Excipients

h1195i (USP)

........................... 1180

Speciﬁc Gravity h841i (USP) .................. 515

Supplemental Information for Articles of Botanical Origin

h2030i (USP)

........................... 559

Tablet Breaking Force h1217i (USP) .............. 1695

Tablet Friability h1216i (USP) .................. 1735

Uniformity of Dosage Units h905i (USP) ........... 1593

Uniformity of Dosage Units h905i (USP erratum) ....... 1601

USP Reference Standards h11i

(USP)

...............................33, 99, 357, 507, 710, 822, 1017, 1154, 1433, 1680

USP Reference Standards h11i (USP erratum) ......... 1019

Validation of Alternative Microbiological Methods h1223i

(USP)

............................... 1475

Validation of Compendial Methods h1225i (USP) ....... 549

Veriﬁcation of Compendial Procedures h1226i (USP) ..... 555

Water Determination h921i (USP) ................ 517

Water for Health Applications h1230i (USP) .......... 1486

Weights and Balances h41i (USP) ................ 508

X-Ray Diffraction h941i (USP) ................. 1241

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Speciﬁcations

Acetanilide (USP)

....................... 572

Acetyl Chloride (USP) ..................... 573

Acetylcholine Chloride (USP) ................ 573

4-Amino-6-chloro-1,3-benzenedisulfonamide (USP) .... 573

2-Aminophenol (USP) ..................... 1487

3-Aminopropionic Acid (USP) ................ 1189

3-Aminosalicylic Acid (USP) ................. 1487

Amyl Acetate (USP) ...................... 574

tert-Amyl Alcohol (USP) ................... 574

Anion-Exchange Resin, Strong, Lightly Cross-Linked,

in the Chloride Form (USP)

................ 858

L-Arabinitol (USP) ....................... 1487

L-Asparagine (USP) ...................... 574

Benzaldehyde (USP) ...................... 574

Benzphetamine Hydrochloride (USP) ............ 575

Benzyltrimethylammonium Chloride (USP) ......... 575

Biphenyl (USP) ......................... 575

N-Bromosuccinimide (USP) .................. 575

1-Butaneboronic Acid (USP) ................. 1189

2,3-Butanedione (USP) .................... 576

n-Butyl Chloride (USP) .................... 576

Butyl Methacrylate (USP) ................... 1189

n-Butylboronic Acid (USP) .................. 1189

Cadmium Acetate (USP) ................... 576

Calcium Citrate (USP) ..................... 577

Calcium Lactate (USP) .................... 577

Casein (USP) .......................... 578

Charcoal, Activated (USP) .................. 578

Chlorobenzene (USP) ..................... 578

Congo Red (USP) ....................... 578

Cyclohexanol (USP) ...................... 579

o-Dichlorobenzene (USP) ................... 579

Dicyclohexyl (USP) ...................... 858

Dicyclohexylamine (USP) ................... 579

Diidoﬂuorescein (USP) .................... 579

1,2-Dimethoxyethane (USP) ................. 580

2-Dimethylaminoethyl Methacrylate (USP) ......... 1190

Docusate Sodium (USP) .................... 1190

Dodecyltrimethylammonium Bromide (USP) ........ 859

Erythritol (USP) ........................ 1487

Ethyl Cyanoacetate (USP) ................... 580

Ethylene Glycol (USP) .................... 580

Ethylene Oxide in Methylene Chloride (50 mg/mL)

(USP)

............................. 859

Ferric Ammonium Citrate (USP) ............... 581

Furfural (USP) ......................... 1190

Galactitol (USP) ........................ 1488

Geneticin (USP) ........................ 1700

Guaiacol (USP) ......................... 581

n-Heptane, Chromatographic (USP) ............. 581

Hexamethyldisilazane (USP) ................. 581

Hexane, Solvent (USP) .................... 582

Hydroxypropyl-beta-cyclodextrin (USP) ........... 1701

Inositol (USP) .......................... 582

Isopropylamine (USP) ..................... 582

Isopropyl Iodide (USP) .................... 1701

Lead Standard Solution (USP) ................ 1488

Magnesium Matrix Modiﬁer (USP) ............. 1488

Maleic Acid (USP) ....................... 583

Methyl Acetate (USP) ..................... 583

Methyl Red (USP) ....................... 108

1-Naphthol (USP) ....................... 583

2-Naphthol (USP) ....................... 583

Nitric Acid, 65 Percent (USP) ................ 1488

5-Nitro-1,10-phenanthroline (USP) .............. 584

Nonylphenoxypoly(ethyleneoxy)ethanol (USP) ....... 584

Palladium Matrix Modiﬁer (USP) .............. 1488

Para-aminobenzoic Acid (USP) ............... 584

Paraformaldehyde (USP) ................... 584

Propionic Anhydride (USP) .................. 585

Pyrrole (USP) .......................... 585

Rose Bengal Sodium (USP) .................. 585

Silver Oxide (USP) ....................... 585

Sodium Arsenite (USP) .................... 586

Sodium Carbonate, Monohydrate (USP) ........... 1701

Sodium Chromate (USP) ................... 586

Sodium Glycocholate (USP) ................. 587

Sodium 1-hexanesulfonate, Monohydrate (USP) ...... 587

Tetramethylammonium Hydroxide (USP) .......... 587

Thioglycolic Acid (USP) ...................587, 1190

Thymol (USP) ......................... 588

n-Tricosane (USP) ....................... 588

Triethylamine (USP) ...................... 588

2,4,6-Trimethylpyridine (USP) ................ 588

1-Vinyl-2-pyrrolidinone (USP) ................108, 1701

Test Solutions

Phenol TS (USP)

........................859, 1489

Sodium Citrate TS, Alkaline (USP) .............859, 1489

Sodium Tetraphenylboron TS (USP) ............. 1489

Volumetric Solutions

Alcoholic Sodium Hydroxide (0.1 N) VS

.......... 1490

Iodine (0.01 N) VS ....................... 1489

Iodine, Hundredth-Normal (0.01 N) (USP erratum) .... 1333

Lithium Methoxide in Methanol (0.1 N) (USP) ......112, 1489

REFERENCE TABLES

Container Speciﬁcations for Capsules and Tablets

(USP)

...............................120, 589, 859, 1191, 1490, 1702

Description and Solubility

(USP)

...............................122, 591, 861, 1193, 1491, 1703

Pharmacopeial Forum

1770

INDEX Vol. 31(6) [Nov.–Dec. 2005]

Index

GENERAL SUBJECTS

Advance Notice of Upcoming Ofﬁcial Revisions to the

USP–NF

.............................21, 308, 692, 1005, 1318

Call for High Priority Monographs for Drug Substances and

Products, and Excipients

....................998, 1309, 1577

Canceled Revision Proposals ...................135, 604, 885, 1212, 1509, 1722

Chromatographic Reagents Now

Available

.............................22, 309, 694, 1006, 1319

Dietary Supplements—Monographs ............... 84, 469

Errata List for USP28–NF23

Aminocaproic Acid

.......................373, 1333

Azithromycin .......................... 1333

Biotechnology-Derived Articles—Tests h1047i ....... 1333

Bisoprolol Fumarate and HydrochlorothiazideTablets ... 712

Bisoprolol Fumarate Tablets ................. 1601

Buproprion Hydrochloride Extended-Release Tablets ... 373

Ceftazidime for Injection ................... 373

Cholecalciferol Solution .................... 35

Cholestyramine Resin ..................... 373

Clavulanate Potassium ..................... 373

Clonidine Transdermal System ................ 373

Diclofenac Sodium Delayed-Release Tablets ........ 1601

Digitalis ............................. 373

Dolasetron Mesylate ...................... 712

Trace Elements Injection ................... 373

Erythromycin Ointment .................... 373

Gadoteridol Injection ...................... 1333

Glimepiride ........................... 713

Glucagon ............................ 712

Iodine, Hundredth-Normal (0.01 N) ............. 1333

Magnesium Salicylate Tablets ................. 1019

Mass Spectrometry h736i ................... 373

Mecamylamine Hydrochloride ................ 373

Meropenem ........................... 35

Methadone Hydrochloride Oral Solution .......... 1333

Metolazone Tablets ....................... 1333

Papain .............................. 712

Particulate Matter in Injections h788i ............ 1601

Pharmaceutical Calculations in Prescription Compounding

h1160i

............................. 373

Phenyltoloxamine Citrate ................... 712

Pregelatinized Starch ...................... 373

Propofol ............................. 1601

Saccharin ............................ 713

Sodium Starch Glycolate ................... 1019

Terazosin Hydrochloride .................... 1019

Tilmicosin Injection ...................... 712

Uniformity of Dosage Units h905i ..............713, 1601

USP Reference Standards h11i ................ 1019

X-Ray Diffraction h941i .................... 713

Expert Committee Designations .................14, 302, 684, 992, 1300, 1568

Fifth Interim Revision ....................... 1323

First Interim Revision ....................... 27

Fourth Interim Revision ...................... 1009

Harmonization

h1i Injections (USP)

......................192, 504, 1149, 1328, 1428, 1599

h267i Porosimetry by Mercury Intrusion (USP) ...... 905

h281i Residue on Ignition (USP) ............... 1526

h429i Light Diffraction Measurement of Particle Size

(USP)

............................. 1234

h616i Bulk Density and Tapped Density (USP) ...... 909

h699i Density of Solids (USP) ................ 912

h701i Disintegration (USP) .................. 194, 358

h711i Dissolution (USP) ....................198, 360, 1691

h724i Drug Release (USP) .................. 213, 367

h811i Powder Fineness (USP) ................ 228

h941i X-Ray Diffraction (USP) ................ 1241

h1216i Tablet Friability (USP) ................ 1735

Anhydrous Citric Acid (USP) .................607, 749, 1016

Aspirin Delayed-Release Capsules (USP) .......... 140, 319

Aspirin Delayed-Release Tablets (USP) ........... 141, 319

Aspirin Extended-Release Tablets (USP) .......... 141, 319

Bupropion Hydrochloride Extended-Release Tablets

(USP)

.............................142, 319, 384

Butylparaben (NF) ....................... 190

Carbamazepine Tablets (USP) ................143, 320, 1044

Carbamazepine Extended-Release Tablets (USP) ...... 143, 321

Cefaclor Extended-Release Tablets (USP) ..........42, 144, 321

Chlorpheniramine Maleate Extended-Release Capsules

(USP)

............................. 144, 321

Chlorpheniramine Maleate and Phenylpropanolamine

Hydrochloride Extended-Release Capsules (USP)

.... 145, 322

Chlorpheniramine Maleate and Phenylpropanolamine

Hydrochloride Extended-Release Tablets (USP)

..... 145, 322

Chlorpheniramine Maleate and Pseudoephedrine

Hydrochloride Extended-Release Capsules (USP)

.... 145, 322

Citric Acid Monohydrate (USP) ...............607, 750, 1016

Clonidine Transdermal System (USP) ............ 146, 323

Diazepam Extended-Release Capsules (USP) ........ 147, 323

Diclofenac Sodium Delayed-Release Tablets

(USP)

.............................148, 324, 751

Diltiazem Hydrochloride Extended-Release Capsules

(USP)

............................. 148, 324

Dirithromycin Delayed-Release Tablets (USP) ....... 151, 327

Disopyramide Phosphate Extended-Release Capsules

(USP)

............................. 152, 327

Divalproex Sodium Delayed-Release Tablets (USP) .... 153, 328

Doxycycline Hyclate Delayed-Release Capsules (USP) .. 154, 328

Erythromycin Delayed-Release Capsules (USP) ...... 154, 328

Erythromycin Delayed-Release Tablets (USP) ....... 154, 329

Conjugated Estrogens Tablets (USP) ............. 155, 329

Felodipine Extended-Release Tablets (USP) ........ 156, 330

Ferrous Fumarate and Docusate Sodium Extended-Release

Tablets (USP)

........................ 158, 332

Garlic Delayed-Release Tablets (USP) ............ 159, 332

Hydroxyzine Hydrochloride Tablets (USP) ......... 159, 332

Indomethacin Extended-Release Capsules (USP) ...... 159, 332

Isosorbide Dinitrate Extended-Release Capsules (USP) .. 160, 333

Isosorbide Dinitrate Extended-Release Tablets

(USP)

.............................161, 333, 1376

Lansoprazole Delayed-Release Capsules (USP) ...... 161, 334

Liothyronine Sodium Tablets (USP) .............162, 334

Lithium Carbonate Extended-Release Tablets (USP) ....162, 335, 1385

Mesalamine Extended-Release Capsules (USP) ....... 163, 336

Mesalamine Delayed-Release Tablets (USP) ........ 164, 337

Methylphenidate Hydrochloride Extended-Release Tablets

(USP)

............................. 164, 337

Metoprolol Succinate Extended-Release Tablets (USP) .. 165, 337

Morphine Sulfate Extended-Release Capsules (USP) ... 165, 338

Nicotine Transdermal System (USP) ............. 166, 338

Nifedipine Extended-Release Tablets (USP) ........ 168, 340

Nitrofurantoin Capsules (USP) ................ 170, 342

Omeprazole Delayed-Release Capsules (USP) .......171, 343, 1392

Oxprenolol Hydrochloride Extended-Release Tablets

(USP)

............................. 173, 345

Oxtriphylline Extended-Release Tablets (USP) ....... 174, 345

Pentoxifylline Extended-Release Tablets (USP) ...... 174, 345

Phenylpropanolamine Hydrochloride Extended-Release

Capsules (USP)

....................... 176, 347

Phenylpropanolamine Hydrochloride Extended-Release

Tablets (USP)

........................ 177, 347

Pilocarpine Ocular System (USP) ..............177, 348

Polyethylene Glycol (NF) ................... 897

Procainamide Hydrochloride Extended-Release Tablets

(USP)

............................. 178, 348

Progesterone Intrauterine Contraceptive System (USP) .. 179, 349

Propranolol Hydrochloride Extended-Release Capsules

(USP)

............................. 180, 350

Propranolol Hydrochloride and Hydrochlorothiazide

Extended-Release Capsules (USP)

............ 181, 350

Pharmacopeial Forum

Vol. 31(6) [Nov.–Dec. 2005]

INDEX 1771

Index

Pseudoephedrine Hydrochloride Extended-Release Capsules

(USP)

............................. 181, 351

Pseudoephedrine Hydrochloride Extended-Release Tablets

(USP)

............................. 182, 351

Quinidine Gluconate Extended-Release Tablets (USP) ... 183, 352

Quinidine Sulfate Extended-Release Tablets (USP) .... 184, 353

Saccharin (NF) ......................... 616

Saccharin Calcium (USP) ................... 607

Saccharin Sodium (USP) ...................612, 1225

Silicon Dioxide (NF) ...................... 1229

Colloidal Silicon Dioxide (NF) ................ 1232

Sodium Starch Glycolate (NF) ................ 1523

Sucrose (NF) .......................... 902

Sulfasalazine Delayed-Release Tablets (USP) ........ 185, 353

Theophylline Extended-Release Capsules (USP) ...... 185, 354

Trihexyphenidyl Hydrochloride Extended-Release Capsules

(USP)

............................. 187, 355

Verapamil Hydrochloride Extended-Release Tablets

(USP)

............................. 188, 356

How to Submit Comments ....................22, 310, 694, 1006, 1320, 1585

How to Use PF ...........................14, 299, 681, 989, 1297, 1565

In Memoriam—Charles Barnstein, Ph.D. ............ 308

In-Process Revision ........................37, 377, 715, 1021, 1335, 1603

Interim Revision Announcements

First Interim Revision

..................... 27

Second Interim Revision .................... 316

Third Interim Revision ..................... 699

Fourth Interim Revision .................... 1009

Fifth Interim Revision ..................... 1323

Sixth Interim Revision ..................... 1589

International Correspondence ...................22, 309, 694, 1006, 1319, 1585

New Director Named for General Policies and

Requirements

........................... 20

New Director Named for Scientiﬁc Administration ...... 20

New Director Named for Volunteer and Organizational

Affairs

............................... 20

Nomenclature ...........................271, 663, 967, 1269, 1539, 1759

Pending Proposals .........................123, 592, 863, 1195, 1493, 1705

Pharmacopeial Education Courses ................21, 309, 693, 1005, 1318, 1585

Policies and Announcements

Advance Notice of Upcoming Ofﬁcial Revisions to the

USP–NF

...........................21, 308, 692, 1005, 1318

Call for High Priority Monographs for Drug Substances and

Products, and Excipients

..................998, 1309, 1577

Chromatographic Reagents Now

Available

...........................22, 309, 694, 1006, 1319

Correction ............................ 1309

How to Submit Comments ..................22, 310, 694, 1006, 1320, 1585

In Memoriam—Charles Barnstein, Ph.D. .......... 308

International Correspondence .................22, 309, 694, 1006, 1319, 1585

New Director Named for General Policies and

Requirements

......................... 20

New Director Named for Scientiﬁc Administration .... 20

New Director Named for Volunteer and Organizational

Affairs

............................ 20

Pharmacopeial Education

Courses

............................21, 309, 693, 1005, 1318, 1585

Pharmacopeial Forum Comment Period Extended ..... 1308

Policy Decisions of the Council of Experts Executive

Committee

.......................... 690

PQRI to Survey Current Excipient Control Practices ...691, 1309

Publication Schedule ......................24, 311, 695, 1008, 1320, 1586

USP Annual Scientiﬁc Meeting ................691, 1004, 1317

USP to Discontinue Posting Labeling Changes to h11i .. 1308

USP Guideline for Submitting Requests for Revision to the

USP–NF

...........................21, 308, 693, 1005, 1318

USP–NF Available in Print, Online, and

..............................22, 309, 693, 1006, 1319

USP Revision Cycle Change ................. 1308

USP Seeks Submission of Proposals for Stability Indicating

Assay Procedures for Steroids

............... 1576

Visit the USP Web Site at

hhttp://www.usp.orgi

....................22, 309, 693, 1006, 1319, 1585

Policy Decisions of the Council of Experts Executive

Committee

............................ 690

PQRI to Survey Current Exipient Control Practices ......691, 1309

Previews

h1058i Analytical Instrument Qualiﬁcation

(USP)

.............................233, 1157, 1453

h1090i Drug Product Interchangeability (USP) ....... 243

Acetazolamide Oral Suspension (USP) ........... 917

Alprazolam Oral Suspension (USP) ............. 918

Azathioprine Oral Suspension (USP) ............ 920

Baclofen Oral Solution (USP) ................ 921

Bethanechol Chloride Oral Suspension (USP) ....... 923

Captopril Oral Suspension (USP) ............... 924

Ciproﬂoxacin Oral Solution (USP) .............. 925

Clonazepam Oral Suspension (USP) ............. 927

Diltiazem Hydrochloride Oral Suspension (USP) ...... 928

Dipyridamole Oral Suspension (USP) ............ 930

Dolasetron Mesylate Oral Suspension (USP) ........ 931

Flucytosine Oral Suspension (USP) ............. 933

Ganciclovir Oral Solution (USP) ............... 934

Isradipine Oral Solution (USP) ................ 936

Labetalol Hydrochloride Oral Suspension (USP) ...... 937

Levothyroxine Sodium Oral Solution (USP) ........ 938

Metolazone Oral Suspension (USP) ............. 940

Metoprolol Tartrate Oral Suspension (USP) ......... 941

Norﬂoxacin Oral Suspension (USP) ............. 943

Ondansetron Hydrochloride Oral Suspension (USP) .... 944

Quinidine Sulfate Oral Suspension (USP) .......... 946

Sumatriptan Succinate Oral Suspension (USP) ....... 947

Verapamil Hydrochloride Oral Suspension (USP) ..... 949

Publication Schedule .......................24, 311, 695, 1008, 1320, 1586

Second Interim Revision ..................... 316

Section Descriptions ........................12, 300, 683

Sixth Interim Revision ...................... 1589

Staff Directory ...........................15, 303, 685, 994

Standards Development ......................7, 295, 677, 985, 1293, 1561

Stimuli to the Revision Process

Basis for Using Moisture Vapor Transmission Rate Per Unit

Product in the Evaluation of Moisture-Barrier Equivalence

of Primary Packages for Solid Oral Dosage Forms, J. Barry,

J. Bergum, Y. Chen, R. Chern, R. Hollander, D. Klein, H.

Lockhart, D. Malinowski, R. McManus, C. Moreton, A.

Mueller, L. Nottingham, C. Okeke, D. O’Reilly, K.

Rinesmith, and S. Shorts

.................. 262

Comments on ‘‘Compendial Calculations: Improving the

Calculations in USP–NF’’, USP Staff

........... 1756

Common Pharmacopeial Calculations in USP Monographs,

Behnam Davani, Karen A. Russo, Andrzej Wilk, and Lokesh

Bhattacharyya

........................ 626

Compendial Calculations: Improving Calculations in USP–

NF, Phillip Travis, Kerrie Heck, Deborah Teitz, Luciano

Virgili, and Mark Wiggins

................. 1749

Critical Quality and Performance Parameters for Modiﬁed-

Release Parenteral Dosage Forms, Diane J. Burgess,

Brian C. Clark, Mary Joan Hampson-Carlin,

and Pankaj Shah

....................... 1745

The Development of Chapter h1235i Vaccines and Vaccine

Test Methods, Barry D. Garﬁnkle, John D. Grabenstein,

and Joan C. May

...................... 1533

HPLC Column Classiﬁcation, Brian Bidlingmeyer, Chung

Chow Chan, Patrick Fastino, Richard Henry, Philip

Koerner, Anne T. Maule, Margareth R.C. Marques, Uwe

Neue, Linda Ng, Horacio Pappa, L1ane Sander, Carmen

Santasania, Lloyd Snyder, Timothy Wozniak

....... 637

Instructions to Authors .....................261, 625, 953, 1257, 1532, 1741

Pharmacopeial Forum

1772

INDEX Vol. 31(6) [Nov.–Dec. 2005]

Index

Isonicotinyl Hydrazone of Rifampicin and Isoniazid: Should It

Be Controlled as a Related Substance (or Impurity) in USP

Monographs for Anti-tuberculosis Combination Products?

T. T. Mariappan, Saranjit Singh, Rajesh Pandey, and

Anshika Sharma

....................... 646

Microbial Testing for Orally Inhaled and Nasal Drug Products,

Lex Adjei, Anton Amann, Jeff Blumenstein, Peter Byron,

Roger Dabbah, Roger Deschenes, Jeffrey Ferguson,

Edward Fitzgerald, Keith Horspool, Stephen Indelicato,

Angel Janney, Michael Korczynski, Bonnie Layton,

Svetlana Lyapustina, Richard Malcolmson, Deborah

Mentel, Julia Mottishaw, Bo Olsson, Guirag Poochikian,

David Porter, James Pfeiffer, Erwin Post, Bryan Riley, Dar

Rosario, Betsy Sawyer, Donald Singer, Terry Tougas,

Roberta Tracy, Patti Valan, and Paul Wright, Michael J.

Brubaker, Donald W. Buckmaster, Peter Byron, Harris

Cummings, Paul D. Curry, Jr., Michael T. Riebe, Charles

G. Thiel, and Caroline C. Vanneste

............ 1258

Process Characterization and Validation for Protein Products,

Janice T. Brown, Gregory C. Davis, John Geigert,

Wesley E. Workman, Lynn C. Yeoman, John Dougherty,

and Kurt Brorson

...................... 954

RSD and Other Variability Measures of the Lognormal

Distribution, Charles Y. Tan

................ 653

The Use of Relative Response Factors to Determine

Impurities, Lokesh Bhattacharyya, Horacio Pappa,

Karen A. Russo, Eric Sheinin, and Roger

L. Williams

.......................... 960

USP Advisory Panels on the USP Performance Test L. Shargel

and T. Foster

......................... 1742

USP International: Responses to Comments on Stimuli

Article, United States Pharmacopeia Staff

........ 1262

The USP Revision Process: Recommendations for

Enhancements, Raﬁk H. Bishara, Susan J. Schniepp,

Barbara Ferguson, Neil Schwarzwalder, Luciano Virgili,

Phyllis Walsh, Mark Wiggins, and Janeen Kincaid

... 656

Third Interim Revision ...................... 699

USP Annual Scientiﬁc Meeting .................691, 1004, 1317

USP Guideline for Submitting Requests for Revision to the

USP–NF

.............................21, 308, 693, 1005, 1318

USP–NF Available in Print, Online, and

.................................22, 309, 693, 1006, 1319

USP Seeks Submission of Proposals for Stability Indicating

Assay Procedures for Steroids

................. 1576

Visit the USP Web Site at

hhttp://www.usp.orgi

......................22, 309, 693, 1006, 1319, 1585

Pharmacopeial Forum

Vol. 31(6) [Nov.–Dec. 2005]

INDEX 1773

Index

[Note—This index covers Vol. 32 No. 1, pp. 1–224; Vol. 32 No.

2, pp. 225–704; Vol. 32 No. 3, pp. 705–987; Vol. 32 No. 4, pp.

989–1388; Vol. 32 No. 5, pp. 1389–1617; Vol. 32 No. 6, pp .

1619–1891]

GENERAL NOTICES AND REQUIREMENTS

Tests and Assays (USP) ........................ 1027

MONOGRAPHS

Acetaminophen, Chlorpheniramine, and Dextromethorphan Tablets

(USP)

................................. 1434

Acetaminophen Extended-Release Tablets (USP) ......... 1666

Tablets Containing at Least Three of the Following–Acetaminophen

and Salts of Chlorpheniramine, Dextromethorphan, and

Pseudoephedrine (USP)

....................... 1030

Acetazolamide Oral Solution (USP) ................. 43

Acetazolamide Oral Suspension (USP) ............... 44

Acetyltriethyl Citrate (NF) ...................... 178

Albendazole Oral Suspension (USP) ................ 46

Albuterol Sulfate (USP) ........................ 1436

Alendronic Acid Tablets (USP) ................... 1423

Alfadex (NF) .............................. 395

Allopurinol (USP) ........................... 302

Almond Oil (NF) ........................... 1147

Alpha Lipoic Acid Capsules (USP) ................. 1764

Alprazolam Oral Suspension (USP) ................. 46

Aluminum Sulfate and Calcium Acetate Powder for Topical

Solution (USP)

............................ 755

Amifostine (USP) ...........................756, 1424

Amifostine for Injection (USP) ....................757, 1424

Aminosalicylate Sodium Tablets (USP) ............... 1437

Aminosalicylic Acid (USP) ...................... 1438

Amlodipine Besylate (USP) ..................... 757

Ammonium Sulfate (NF errata) ................... 292

Amoxicillin Capsules (USP) ..................... 47, 743

Amoxicillin Tablets (USP) ......................305, 1030

Apomorphine Hydrochloride (USP) ................. 1438

Atracurium Besylate (USP) ...................... 305

Azathioprine Oral Suspension (USP) ................ 48

Azithromycin (USP) .......................... 306

Baclofen Oral Solution (USP) .................... 49

Baclofen Oral Suspension (USP) .................. 51

Bemotrizinol (USP) .......................... 1044

Benazepril Hydrochloride (USP) ................... 1438

Benazepril Hydrochloride Tablets (USP) .............. 52

Benzonatate Capsules (USP) ..................... 55

Bethanechol Chloride Oral Solution (USP) ............. 55

Bethanechol Chloride Oral Suspension (USP) ........... 57

Bismuth Subsalicylate Tablets (USP) ................ 1440

Bisoctrizole (USP) ........................... 309

Bisoprolol Fumarate and Hydrochlorothiazide Tablets (USP

erratum)

................................ 291

Bisoprolol Fumarate Tablets (USP) ................. 1666

Bromocriptine Mesylate Capsules (USP) .............. 58

Bupropion Hydrochloride Extended-Release Tablets (USP) ...312, 1047

Butorphanol Tartrate Nasal Solution (USP) ............. 1049

Calcitonin Salmon (USP) ....................... 760

Calcitonin Salmon Nasal Solution (USP) .............. 767

Calcitriol (USP) ............................ 58

Calcitriol Injection (USP) ....................... 61

Calcium Glycerophosphate (USP) .................. 1765

Calcium Pantothenate (USP) ..................... 62

Dibasic Calcium Phosphate Dihydrate (USP) ........... 1329

Anhydrous Dibasic Calcium Phosphate (USP) ........... 1332

Capecitabine (USP) .......................... 1052

Capecitabine Tablets (USP) ...................... 1054

Captopril Oral Solution (USP) .................... 63

Captopril Oral Suspension (USP) .................. 64

Carbamazepine (USP) ......................... 65

Carbomer Copolymer (NF) ...................... 1481

Carbomer Homopolymer (NF erratum) ............... 37

Carprofen (USP) ............................ 1667

Carprofen Tablets (USP) ....................... 1669

Carvedilol (USP) ............................ 1057

Cat’s Claw (USP) ........................... 1120

Powdered Cat’s Claw (USP) ..................... 1124

Powdered Cat’s Claw Extract (USP) ................1124, 1127

Cat’s Claw Capsules (USP) ...................... 1126

Cefaclor Tablets (USP) ........................ 314

Cefadroxil for Oral Suspension (USP) ............... 315

Cefepime Hydrochloride (USP) ................... 316

Cefonicid for Injection (USP) .................... 67

Ceftazidime (USP) ........................... 67

Ceftazidime for Injection (USP) ................... 68

Ceftazidime Injection (USP) ..................... 68

Cellacefate (NF) ............................ 179

Cetirizine Hydrochloride (USP) ................... 317

Chlorhexidine Gluconate Oral Rinse (USP) ............ 768

Chlorhexidine Gluconate Solution (USP) .............. 768

Chlorophyllin Copper Complex Sodium (USP) .......... 769

Chlorthalidone (USP) ......................... 68

Cholestyramine Resin (USP) ..................... 320

Cilostazol (USP) ............................69, 1441

Cimetidine (USP) ........................... 769

Cimetidine Tablets (USP) ....................... 72

Ciproﬂoxacin (USP) .......................... 320

Ciproﬂoxacin and Dexamethasone Otic Suspension (USP) .... 321

Ciproﬂoxacin Hydrochloride (USP) ................. 325

Ciproﬂoxacin Injection (USP) ....................326, 1059

Citalopram Hydrobromide (USP) .................. 1060

Citalopram Tablets (USP) ....................... 770

Cladribine (USP) ............................774, 1425

Clarithromycin Extended-Release Tablets (USP) .........775, 1425

Clarithromycin Extended-Release Tablets (USP erratum) ..... 748

Clonazepam Oral Suspension (USP) ................ 73

Clopidogrel Bisulfate (USP) ..................... 74

Clopidogrel Tablets (USP) ...................... 76, 743

Clotrimazole Lozenges (USP) .................... 78

Coconut Oil (NF) ........................... 397

Cod Liver Oil (USP) ......................... 1443

Black Cohosh (USP) ......................... 1128

Powdered Black Cohosh (USP) ................... 1132

Powdered Black Cohosh Extract (USP) ............... 1133

Black Cohosh Fluidextract (USP) .................. 1134

Black Cohosh Tablets (USP) ..................... 1135

High Fructose Corn Syrup (NF) ................... 1151

Dantrolene Sodium (USP) ...................... 327

Dantrolene Sodium Capsules (USP) ................. 1063

Dantrolene Sodium for Injection (USP) ............... 779

Dextroamphetamine Sulfate Tablets (USP erratum) ........ 1035

Diazepam Extended-Release Capsules (USP) ........... 330

Didanosine (USP) ........................... 781

Didanosine Tablets (USP) ......................784, 1444

Diltiazem Hydrochloride Extended-Release Capsules (USP) ... 1673

Diltiazem Hydrochloride Oral Solution (USP) ........... 79

Diltiazem Hydrochloride Oral Suspension (USP) ......... 80

Dipyridamole Oral Suspension (USP) ................ 81

Divalproex Sodium (USP) ...................... 1675

Dolasetron Mesylate Oral Solution (USP) ............. 83

Dolasetron Mesylate Oral Suspension (USP) ............ 84

Doxazosin Mesylate (USP) ...................... 1066

Doxepin Hydrochloride (USP) .................... 330

Dronabinol (USP) ........................... 86

Dronabinol Capsules (USP erratum) ................. 1430

Drospirenone (USP) .......................... 787

Edetate Calcium Disodium (USP) .................. 1335

Edetate Disodium (USP) ....................... 1070

Edetate Disodium Injection (USP) .................. 1071

Ensulizole (USP) ............................ 1677

Esteriﬁed Estrogens (USP) ...................... 1678

Esteriﬁed Estrogens Tablets (USP) ................. 1680

Estradiol Vaginal Inserts (USP) ................... 1071

Conjugated Estrogens Tablets (USP) ................ 1074

Ethotoin Tablets (USP) ........................ 332

Famotidine Injection (USP) ...................... 333

Famotidine Tablets (USP) ...................... 1680

Felodipine Extended-Release Tablets (USP) ............ 89, 743

Fexofenadine Hydrochloride (USP) ................. 1447

Fexofenadine Hydrochloride Capsules (USP) ........... 1449

Finasteride Tablets (USP) ....................... 1681

Fluconazole (USP) ........................... 335

Pharmacopeial Forum

1882

INDEX Vol. 32(6) [Nov.–Dec. 2006]

Index

Flucytosine Oral Suspension (USP) ................. 92

Flumazenil (USP) ........................... 94

Fluoxetine Delayed-Release Capsules (USP) ............337, 1030

Fluticasone Propionate (USP) .................... 95, 337

Fluticasone Propionate Nasal Spray (USP) ............. 97, 339

Fluvastatin Capsules (USP) ...................... 105

Fluvastatin Sodium (USP) ......................103, 1682

Fluvoxamine Maleate (USP) .....................344, 1449

Fluvoxamine Maleate Tablets (USP) ................ 1684

Formoterol Fumarate (USP) .....................106, 1450

Fosinopril Sodium (USP) .......................110, 789, 1686

Gabapentin (USP) ........................... 1689

Gabapentin Capsules (USP) ..................... 1693

Gabapentin Tablets (USP) ...................... 1695

Ganciclovir Oral Suspension (USP) ................. 113

Gemcitabine Hydrochloride (USP) ................. 114

Ginger (USP) .............................. 160

Ginger Capsules (USP) ........................ 163

Powdered Ginger (USP) ....................... 162

Ginger Tincture (USP) ........................ 163

Ginkgo (USP) ............................. 164

Ginkgo Capsules (USP) ........................ 172

Powdered Ginkgo Extract (USP) ................... 166

Ginkgo Tablets (USP) ......................... 174

Glipizide (USP) ............................ 1453

Glipizide and Metformin Hydrochloride Tablets (USP) ...... 1076

Glucagon (USP) ............................ 266

Glucosamine, Chondroitin Sulfate Sodium and

Methylsulfonylmethane Tablets (USP)

.............. 1138

Glucosamine and Methylsulfonylmethane Tablets (USP) ..... 1137

Glucosamine Tablets (USP) ..................... 1137

Glutamine (USP erratum) ....................... 1430

Glyburide Tablets (USP) ....................... 1080

Glyceryl Monolinoleate (NF erratum) ................ 37

Goldenseal (USP) ........................... 35

Powdered Goldenseal (USP) ..................... 36

Powdered Goldenseal Extract (USP) ................ 36

Goserelin Acetate (USP) ....................... 792

Helium (USP erratum) ........................ 291

Hydrocortisone Tablets (USP) .................... 1083

Hydroxypropyl Betadex (NF) .................... 1481

Hydroxyzine Hydrochloride (USP) .................114, 1456

Hypromellose (USP) ......................... 1573

Hypromellose Ophthalmic Solution (USP) ............. 1084

Ibuprofen (USP) ............................ 796

Ibuprofen Oral Suspension (USP) .................. 796

Ibuprofen Tablets (USP) ....................... 798

Imipenem and Cilastatin for Injection (USP) ............ 1698

Imipenem and Cilastatin for Injectable Suspension (USP) .... 1698

Indinavir Sulfate (USP) ........................ 345

Indium In 111 Chloride Solution (USP) ............... 1698

Indocyanine Green (USP) ....................... 1427

Iodoform (USP) ............................ 115

Irbesartan (USP) ............................115, 799, 1084

Irbesartan Tablets (USP) ....................... 799

Isomalt (NF) .............................. 1154

Diluted Isosorbide Mononitrate (USP) ...............268, 1699

Isosorbide Mononitrate Tablets (USP) ................ 1700

Isosorbide Mononitrate Extended-Release Tablets (USP) ..... 1703

Labetalol Hydrochloride Oral Solution (USP) ........... 116

Labetalol Hydrochloride Oral Suspension (USP) ......... 117

Lactulose Concentrate (USP) ..................... 1709

Lamivudine (USP) ........................... 346

Lansoprazole (USP) .......................... 1710

Leﬂunomide Tablets (USP) ...................... 1712

Levodopa (USP) ............................ 1085

Levoﬂoxacin (USP) .......................... 347

Lipid Injectable Emulsion (USP) .................. 350

Lisinopril Tablets (USP) ....................... 1086

Lithium Carbonate Extended-Release Tablets (USP) ....... 35

Loperamide Hydrochloride Oral Solution (USP) .......... 353

Loratadine and Pseudoephedrine Sulfate Extended-Release Tablets

(USP)

................................. 1715

Lovastatin (USP) ............................ 118

Lovastatin Tablets (USP) ....................... 1458

Magnesium Carbonate (USP) .................... 1719

Magnesium Chloride (USP) ..................... 1720

Magnesium Hydroxide (USP) .................... 1087

Magnesium Hydroxide Paste (USP) ................. 1088

Magnesium Oxide (USP) ....................... 1720

Mannitol Injection (USP) ....................... 263

Maritime Pine (USP) ......................... 1140

Maritime Pine Extract (USP) ..................... 1142

Mebendazole Oral Suspension (USP) ................ 119

Meloxicam Oral Suspension (USP) ................. 1721

Meloxicam Tablets (USP) ...................... 1460

Meropenem for Injection (USP) ................... 1724

Metformin Hydrochloride Tablets (USP) .............. 1725

Metformin Hydrochloride Extended-Release Tablets (USP) ... 1726

Methyldopa Oral Suspension (USP) ................. 354

Methylprednisolone (USP) ...................... 354

Methylsulfonylmethane (USP) .................... 826

Methylsulfonylmethane Tablets (USP) ............... 827

Metolazone Oral Suspension (USP) ................. 119

Metoprolol Tartrate (USP) ...................... 1089

Metoprolol Tartrate Oral Solution (USP) .............. 121

Metoprolol Tartrate Oral Suspension (USP) ............ 122

Miconazole Nitrate Cream (USP) .................. 123

Milk of Magnesia (USP) ....................... 353

Minerals Capsules (USP) ....................... 1474

Minerals Tablets (USP) ........................ 1474

Mitoxantrone Injection (USP) .................... 355

Morantel Tartrate (USP) .......................355, 1735

Morphine Sulfate Extended-Release Capsules (USP) ....... 124

Naproxen Delayed-Release Tablets (USP) ............. 124

Narasin Granular (USP) ........................ 124

Narasin Premix (USP) ......................... 126

Naratriptan Hydrochloride (USP) .................. 1462

Nefazodone Hydrochloride (USP) ..................802, 1462

Netilmicin Sulfate (USP) ....................... 1089

Nevirapine Oral Suspension (USP) ................. 1090

Nevirapine Tablets (USP) ....................... 807

Nifedipine Extended-Release Tablets (USP) ............355, 1031

Nimodipine (USP) ........................... 360

Nitrofurantoin Capsules (USP) .................... 1428

Nitrogen (NF erratum) ........................ 293

Nitrogen 97 Percent (NF erratum) .................. 293

Nitrous Oxide (USP erratum) .................... 292

Norethindrone Tablets (USP) ..................... 1736

Norgestimate (USP) .......................... 1094

Oﬂoxacin Tablets (USP) ....................... 1737

Oil- and Water-Soluble Vitamins with Minerals Capsules (USP) 1474

Oil- and Water-Soluble Vitamins with Minerals Oral Solution

(USP)

................................. 1475

Oil- and Water-Soluble Vitamins with Minerals Tablets (USP) . 1476

Oleic Acid (NF) ............................ 1771

Ondansetron Hydrochloride (USP) ................. 126

Ondansetron Hydrochloride Oral Suspension (USP) ....... 127

Ondansetron Injection (USP) ..................... 1096

Ondansetron Orally Disintegrating Tablets (USP erratum) .... 1430

Ondansetron Orally Disintegrating Tablets (USP) ......... 1463

Ondansetron Oral Solution (USP) .................. 128

Orlistat Capsules (USP) ........................ 1739

Oxandrolone Tablets (USP) ...................... 1464

Oxaprozin (USP) ............................ 130

Oxaprozin Tablets (USP) ....................... 130

Oxybutynin Chloride (USP) ..................... 810

Oxybutynin Chloride Extended-Release Tablets (USP) ...... 1742

Oxycodone Hydrochloride Extended-Release Tablets (USP) ... 1745

Oxytocin Injection (USP) ....................... 1750

Paclitaxel (USP) ............................ 361

Palm Kernel Oil (NF) ......................... 1486

Pamidronate Disodium for Injection (USP) ............. 1465

Pancuronium Bromide (USP) .................... 130

Pancuronium Bromide Injection (USP) ............... 1097

Paricalcitol (USP) ........................... 132

Paroxetine Hydrochloride (USP) ................... 811

PEG 3350 and Electrolytes for Oral Solution (USP) ....... 1104

Pentobarbital Sodium Injection (USP) ............... 364

Permethrin (USP) ........................... 1100

Permethrin Cream (USP) ....................... 1102

Phenoxybenzamine Hydrochloride Capsules (USP) ........ 1750

Pharmacopeial Forum

Vol. 32(6) [Nov.–Dec. 2006]

INDEX 1883

Index

Piroxicam Cream (USP) ....................... 134

Polydextrose (NF) ........................... 1155

Polyethylene Oxide (NF) ....................... 398

Polyisobutylene (NF) ......................... 828

Polyoxyl 10 Oleyl Ether (NF) .................... 1488

Polyvinyl Acetate (NF) ........................ 400

Potassium Perchlorate (USP) ..................... 364

Pravastatin Sodium (USP) ...................... 813

Pravastatin Sodium Tablets (USP) .................. 817

Prednicarbate Cream (USP) ..................... 819

Prednicarbate Ointment (USP) .................... 822

Prednisolone Sodium Phosphate (USP) ............... 365

Prednisolone Tablets (USP erratum) ................. 1430

Promethazine Hydrochloride (USP) .................365, 1105

Promethazine Hydrochloride Tablets (USP) ............367, 1107

Pseudoephedrine Sulfate (USP) ................... 135

Pyrantel Pamoate (USP) ....................... 1465

Pyridoxine Hydrochloride Injection (USP) ............. 369

Quazepam Tablets (USP) ....................... 370

Quinidine Sulfate Oral Suspension (USP) ............. 136

Racepinephrine Hydrochloride (USP) ................ 1752

Ranitidine Hydrochloride (USP) ................... 1752

Ranitidine Injection (USP erratum) ................. 1660

Ranitidine Oral Solution (USP erratum) .............. 1660

Ranitidine in Sodium Chloride Injection (USP erratum) ..... 1661

Ranitidine Tablets (USP erratum) .................. 1661

Fully Hydrogenated Rapeseed Oil (NF) ............... 1771

Superglycerinated Fully Hydrogenated Rapeseed Oil (NF) .... 1773

Risperidone Tablets (USP) ...................... 1109

Ritonavir (USP) ............................370, 1113

Ropivacaine Hydrochloride Injection (USP) ............ 374

Saccharin Calcium (USP) ....................... 1114

Saccharin Sodium (USP erratum) .................. 1035

Saccharin Sodium (USP) ....................... 1114

Saquinavir Capsules (USP) ...................... 824

Senna (USP) .............................. 137

Senna Pods (USP) ........................... 140

Sennosides (USP) ........................... 141

Simvastatin (USP) ........................... 141

Sodium Bicarbonate (USP) ...................... 1465

Sodium Chloride (USP) ........................ 264

Sodium Fluoride (USP) ........................ 1466

Sodium Fluoride and Phosphoric Acid Topical Solution (USP) . 824

Sodium Fluoride Oral Solution (USP) ................ 1466

Sodium Salicylate Tablets (USP) .................. 825

Sodium Tartrate (NF) ......................... 1776

Sorbitol Sorbitan Solution (USP) .................. 270

Spironolactone and Hydrochlorothiazide Tablets (USP) ..... 376

Stearyl Alcohol (NF) ......................... 1777

Strawberry Syrup (NF) ........................ 179

Streptomycin Sulfate (USP) ..................... 1467

Succinic Acid (NF) .......................... 1777

Succinylcholine Chloride (USP) ................... 1754

Succinylcholine Chloride for Injection (USP erratum) ...... 1661

Sugar Spheres (NF) .......................... 1777

Sumatriptan Succinate Oral Suspension (USP) ........... 144

Tazobactam (USP) ........................... 1755

Temazepam (USP) ........................... 145

Thalidomide (USP) ..........................146, 1467

Thalidomide Capsules (USP) ..................... 1468

Thimerosal (USP) ........................... 147

Tiagabine Hydrochloride (USP) ................... 1468

Tiamulin Fumarate (USP erratum) .................. 37

Tiamulin Fumarate (USP) ....................... 1115

Tizanidine Hydrochloride (USP) ...................746, 1757

Tizanidine Tablets (USP) ....................... 147

Travoprost (USP) ........................... 1115

Travoprost Ophthalmic Solution (USP) ............... 1118

Triamcinolone Diacetate (USP) ................... 1120

Tribasic Sodium Phosphate (NF) .................. 402

Tributyl Citrate (NF) ......................... 179

Triclosan (USP) ............................ 377

Triethyl Citrate (NF) .......................... 180

Trimipramine Maleate (USP) ..................... 1759

Crystallized Trypsin (USP) ...................... 779

Tyrosine (USP) ............................. 1761

Compound Undecylenic Acid Ointment (USP erratum) ..... 1430

Valerian (USP) .............................394, 1034

Powdered Valerian (USP) .......................395, 1034

Valerian Tablets (USP) ........................ 395

Valganciclovir Hydrochloride (USP) ................ 379

Valganciclovir Tablets (USP) ..................... 384

Valproic Acid Injection (USP) .................... 387

Valsartan (USP) ............................ 150

Verapamil Hydrochloride (USP) ................... 389

Verapamil Hydrochloride Injection (USP) .............154, 1762

Verapamil Hydrochloride Oral Solution (USP) ........... 155

Verapamil Hydrochloride Oral Suspension (USP) ......... 156

Verapamil Hydrochloride Tablets (USP) ..............158, 1763

Vinblastine Sulfate (USP) ....................... 1470

Vinblastine Sulfate for Injection (USP) ............... 1470

Vincristine Sulfate (USP) ....................... 1470

Vincristine Sulfate for Injection (USP) ............... 1470

Vincristine Sulfate Injection (USP) ................. 1470

Vinorelbine Injection (USP) .....................825, 1471

Vinorelbine Tartrate (USP) ...................... 1471

Sterile Water for Inhalation (USP erratum) ............. 37

Sterile Water for Inhalation (USP) .................. 1033

Sterile Water for Injection (USP erratum) .............. 37

Sterile Water for Injection (USP) .................. 1033

Sterile Water for Irrigation (USP erratum) ............. 37

Sterile Water for Irrigation (USP) .................. 1033

Sterile Puriﬁed Water (USP erratum) ................ 37

Sterile Puriﬁed Water (USP) ..................... 1033

Water for Hemodialysis (USP erratum) ............... 37

Water for Hemodialysis (USP) .................... 1033

Water-Soluble Vitamins with Minerals Capsules (USP) ...... 1476

Water-Soluble Vitamins with Minerals Oral Solution (USP) ... 1477

Water-Soluble Vitamins with Minerals Tablets (USP) ....... 1477

Yohimbine Injection (USP erratum) ................. 748

Zidovudine Tablets (USP) ...................... 158

Zinc Chloride Injection (USP) .................... 1473

Zinc Sulfate Tablets (USP) ...................... 1034

EXCIPIENTS

Excipients, USP and NF Excipients, Listed by Category (NF) ..390, 1144, 1478, 1768

GENERAL CHAPTERS

Acoustic Emission h1005i (USP) .................. 1504

Alcohol Determination h611i (USP) ................. 830

Alginates Assay h311i (USP) .................... 516

Analytical Instrument Qualiﬁcation h1058i (USP) .........595, 1784

Biotechnology-Derived Articles—Amino Acid Analysis h1052i

(USP)

................................. 542

Biotechnology-Derived Articles—Capillary Electrophoresis h1053i

(USP)

................................. 559

Biotechnology-Derived Articles—Isoelectric Focusing h1054i

(USP)

................................. 568

Biotechnology-Derived Articles—Peptide Mapping h1055i (USP) 571

Biotechnology-Derived Articles—Polyacrylamide Gel

Electrophoresis h1056i (USP)

................... 580

Biotechnology-Derived Articles—Tests h1047i (USP) ...... 516

Biotechnology-Derived Articles—Total Protein Assay h1057i

(USP)

................................. 589

Chromatography h621i (USP) ....................265, 831, 1163

Containers—Glass h660i (USP) ................... 1171

Containers—Performance Testing h671i (USP) .......... 1193

Containers—Plastics h661i (USP) .................. 1176

Disintegration and Dissolution of Dietary Supplements h2040i

(USP)

.................................184, 1795

Dissolution h711i (USP) ....................... 286

Distilling Range h721i (USP) .................... 1200

Elastomeric Closures for Injections h381i (USP erratum) ..... 292

Emergency Medical Services Vehicles and Ambulances—Storage

of Preparations h1070i (USP)

................... 605

Fats and Fixed Oils h401i (USP) .................. 1492

Good Repackaging Practices h1178i (USP) ............ 1523

Good Storage and Shipping Practices h1079i (USP) ....... 1208

Heavy Metals h231i (USP) ......................182, 747

Impurities in Ofﬁcial Articles h1086i (USP) ............ 1509

Injections h1i (USP) .......................... 402

Insulin Assays h121i (USP erratum) ................ 1661

Pharmacopeial Forum

1884

INDEX Vol. 32(6) [Nov.–Dec. 2006]

Index

Ion Chromatography h1065i (USP) ................. 899

Monitoring Devices—Time, Temperature, and Humidity h1118i

(USP)

................................. 900

Nomenclature h1121i (USP) ..................... 1228

Ordinary Impurities h466i (USP) .................. 1493

Organic Volatile Impurities h467i (USP) .............. 270

Osmolality and Osmolarity h785i (USP) .............. 850

Pharmaceutical Compounding—Sterile Preparations h797i (USP) 852

Pharmaceutical Stability h1150i (USP) ............... 1232

Plasma Spectrochemistry h730i (USP) ............... 836

Quality Assurance in Pharmaceutical Compounding h1163i(USP) 1517

Raman Spectrophotometry h1120i (USP) .............. 1211

Repackaging into Single-Unit Containers and Unit-Dose Containers

for Nonsterile Solids and Liquid Dosage Forms h681i (USP)

. 1197

Residual Solvents h467i (USP) ...................277, 1494

Tablet Friability h1216i (USP) .................... 289

Uniformity of Dosage Units h905i (USP) .............1201, 1653

USP Reference Standards h11i (USP) ................1491, 1779

Veriﬁcation of Compendial Procedures h1226i (USP) ....... 1232

Volumetric Apparatus h31i (USP) .................. 1780

Water for Pharmaceutical Purposes h1231i (USP) ......... 1528

Weights and Balances h41i (USP) ..................514, 1781

REAGENTS, INDICATORS, AND SOLUTIONS

Chromatographic Reagents (USP) ................. 1293

Reagent Speciﬁcations

Acetaldehyde (USP)

........................ 607

Acetanilide (USP) ......................... 608

Acetic Acid, Glacial (USP) .................... 608

Acetic Anhydride (USP) ...................... 608

Acetone (USP) ........................... 608

Acetonitrile (USP) ......................... 608

Acetophenone (USP) ........................ 609

p-Acetotoluidide (USP) ...................... 609

Acetylacetone (USP) ........................ 609

Acetyl Chloride (USP) ....................... 609

Acetylcholine Chloride (USP) .................. 610

Acrylic Acid (USP) ........................ 610

Adipic Acid (USP) ......................... 610

Alprenolol Hydrochloride (USP) ................. 610

Alum (USP) ............................. 611

Alumina, Activated (USP) ..................... 611

Alumina, Anhydrous (USP) .................... 611

Aluminon (USP) .......................... 611

Aluminum (USP) .......................... 611

Aluminum Oxide, Acid-Washed (USP) ............. 611

Aluminum Potassium Sulfate (USP) ............... 612

Amaranth (USP) .......................... 612

Aminoacetic Acid (USP) ..................... 612

4-Aminoantipyrine (USP) ..................... 612

4-Amino-6-chloro-1,3-benzenedisulfonamide (USP) ...... 613

4-Amino-2-chlorobenzoic Acid (USP) .............. 613

2-Amino-5-chlorobenzophenone (USP) ............. 613

1-(2-Aminoethyl)piperazine (USP) ................ 613

Aminoguanidine Bicarbonate (USP) ............... 613

N-Aminohexamethyleneimine (USP) ............... 614

4-Amino-3-hydroxy-1-naphthalenesulfonic Acid (USP) .... 614

m-Aminophenol (USP) ....................... 614

p-Aminophenol (USP) ....................... 614

3-Amino-1-propanol (USP) .................... 614

Ammonia Water, 25 Percent (USP) ............... 615

Ammonia Water, Stronger (USP) ................. 615

Ammonium Acetate (USP) .................... 615

Ammonium Bisulfate (USP) ................... 615

Ammonium Bromide (USP) .................... 615

Ammonium Carbonate (USP) ................... 615

Ammonium Chloride (USP) .................... 616

Ammonium Citrate, Dibasic (USP) ............... 616

Ammonium Fluoride (USP) .................... 616

Ammonium Hydroxide (USP) .................. 616

Ammonium Molybdate (USP) .................. 616

Ammonium Nitrate (USP) ..................... 616

Ammonium Oxalate (USP) .................... 617

Ammonium Persulfate (USP) ................... 617

Ammonium Phosphate, Dibasic (USP) ............. 617

Ammonium Phosphate, Monobasic (USP) ........... 617

Ammonium Reineckate (USP) .................. 617

Ammonium Sulfamate (USP) ................... 617

Ammonium Sulfate (USP) ..................... 618

Ammonium Thiocyanate (USP) ................. 618

Ammonium Vanadate (USP) ................... 618

Amyl Acetate (USP) ........................ 618

Amyl Alcohol (USP) ........................ 618

tert-Amyl Alcohol (USP) ..................... 619

Aniline (USP) ............................ 619

Aniline Blue (USP) ........................ 619

Anisole (USP) ........................... 619

Anthracene (USP) ......................... 619

Anthrone (USP) ........................... 620

Antimony Pentachloride (USP) .................. 620

Antimony Trichloride (USP) ................... 620

Aprobarbital (USP) ......................... 620

Arsenazo III Acid (USP) ..................... 621

Arsenic Trioxide (USP) ...................... 621

L-Asparagine (USP) ........................ 621

Barium Chloride (USP) ...................... 621

Barium Chloride, Anhydrous (USP) ............... 622

Barium Hydroxide (USP) ..................... 622

Barium Nitrate (USP) ....................... 622

Benzaldehyde (USP) ........................ 622

Benzamidine Hydrochloride Hydrate (USP) .......... 622

Benzanilide (USP) ......................... 623

Benzene (USP) ........................... 623

Benzenesulfonamide (USP) .................... 623

Benzenesulfonyl Chloride (USP) ................. 623

Benzhydrol (USP) ......................... 623

Benzoic Acid (USP) ........................ 623

Benzophenone (USP) ....................... 624

p-Benzoquinone (USP) ...................... 624

3-Benzoylbenzoic Acid (USP) .................. 624

Benzoyl Chloride (USP) ...................... 624

Benzoylformic Acid (USP) .................... 624

Benzphetamine Hydrochloride (USP) .............. 624

2-Benzylaminopyridine (USP) .................. 625

1-Benzylimidazole (USP) ..................... 625

Benzyltrimethylammonium Chloride (USP) ........... 625

Bibenzyl (USP) ........................... 625

Biphenyl (USP) ........................... 625

2,2’-Bipyridine (USP) ....................... 626

4,4’-Bis(4-amino-1-naphthylazo)-2,2’-stilbenedisulfonic Acid

(USP)

............................... 626

Bis(2-ethylhexyl) Maleate (USP) ................. 626

Bis(2-ethylhexyl) Phthalate (USP) ................ 626

Bis(2-ethylhexyl) Sebacate (USP) ................ 626

Bis(2-ethylhexyl)phosphoric Acid (USP) ............ 627

Bis(trimethylsilyl)acetamide (USP) ................ 627

Bis(trimethylsilyl)triﬂuoroacetamide (USP) ........... 627

Bis(trimethylsilyl)triﬂuoroacetamide with Trimethylchlorosilane

(USP)

............................... 627

Blue Tetrazolium (USP) ...................... 627

Boric Acid (USP) .......................... 628

Boron Triﬂuoride (USP) ...................... 628

14% Boron Triﬂuoride–Methanol (USP) ............ 628

Brilliant Green (USP) ....................... 628

Bromine (USP) ........................... 629

p-Bromoaniline (USP) ....................... 629

N-Bromosuccinimide (USP) .................... 629

Brucine Sulfate (USP) ....................... 629

1,3-Butanediol (USP) ....................... 629

2,3-Butanedione (USP) ...................... 630

Butyl Acetate, Normal (USP) ................... 630

Butyl Alcohol (USP) ........................ 630

Butyl Alcohol, Secondary (USP) ................. 630

Butyl Alcohol, Tertiary (USP) .................. 630

Butyl Benzoate (USP) ....................... 631

n-Butyl Chloride (USP) ......................631, 1239

Butyl Ether (USP) ......................... 631

tert-Butyl Methyl Ether (USP) .................. 631

n-Butylamine (USP) ........................ 631

tert-Butylamine (USP) ....................... 632

n-Butyl Chloride (USP) ......................631, 1239

4-tert-Butylphenol (USP) ..................... 632

Pharmacopeial Forum

Vol. 32(6) [Nov.–Dec. 2006]

INDEX 1885

Index

Butyraldehyde (USP) ....................... 632

Butyric Acid (USP) ........................ 632

Butyrolactone (USP) ........................ 633

Cadmium Acetate (USP) ..................... 633

Cadmium Nitrate (USP) ...................... 633

Calcium Acetate (USP) ...................... 634

Calcium Carbonate (USP) ..................... 634

Calcium Carbonate, Chelometric Standard (USP) ....... 634

Calcium Chloride (USP) ...................... 634

Calcium Chloride, Anhydrous (USP) .............. 634

Calcium Citrate (USP) ....................... 634

Calcium Hydroxide (USP) .................... 635

Calcium Lactate (USP) ...................... 635

Calcium Nitrate (USP) ....................... 635

Calcium Sulfate (USP) ....................... 635

dl-10-CamphorsulfonicAcid (USP) ................ 636

Capric Acid (USP) ......................... 636

Carbazole (USP) .......................... 636

Carbon Disulﬁde, CS (USP) ................... 636

Carbon Tetrachloride (USP) .................... 636

Carboxymethoxylamine Hemihydrochloride (USP) ...... 637

Casein (USP) ............................ 637

Casein, Hammersten (USP) .................... 1239

Catechol (USP) ........................... 637

Cedar Oil (USP) .......................... 637

Ceric Sulfate (USP) ........................ 638

Chenodeoxycholic Acid (USP) .................. 638

Chloramine T (USP) ........................ 638

Chlorine (USP) ........................... 638

1-Chloroadamantane (USP) .................... 639

3-Chloroaniline (USP) ....................... 639

Chlorobenzene (USP) ....................... 639

m-Chlorobenzoic Acid (USP) ................... 639

4-Chlorobenzoic Acid (USP) ................... 639

4-Chlorobenzophenone (USP) .................. 640

Chloroform (USP) ......................... 640

Chlorogenic Acid (USP) ...................... 640

1-Chloronaphthalene (USP) .................... 640

2-Chloronicotinic Acid (USP) ................... 640

2-Chloro-4-nitroaniline, 99% (USP) ............... 641

Chloroplatinic Acid (USP) .................... 641

5-Chlorosalicylic Acid (USP) ................... 641

Chlorotrimethylsilane (USP) ................... 641

Cholestane (USP) .......................... 641

Cholesteryl Benzoate (USP) .................... 641

Choline Chloride (USP) ...................... 642

Chromium Trioxide (USP) .................... 642

Chromotropic Acid (USP) ..................... 642

Chromotropic Acid Disodium Salt (USP) ............ 642

Cinchonidine (USP) ........................ 642

Cinchonine (USP) ......................... 643

Citric Acid, Anhydrous (USP) .................. 643

Cobalt Chloride (USP) ....................... 643

Cobalt Nitrate (USP) ........................ 643

Cobaltous Acetate (USP) ..................... 643

Congo Red (USP) ......................... 643

Coomassie Brilliant Blue R-250 (USP) ............. 644

Copper (USP) ............................ 644

Cortisone (USP) .......................... 644

m-Cresol Purple (USP) ....................... 644

Cupric Acetate (USP) ....................... 644

Cupric Chloride (USP) ....................... 645

Cupric Citrate (USP) ........................ 645

Cupric Sulfate, Anhydrous (USP) ................ 645

Cyanoacetic Acid (USP) ...................... 645

Cyanogen Bromide (USP) ..................... 645

Cyclohexane (USP) ........................ 645

Cyclohexanol (USP) ........................ 646

L-Cystine (USP) .......................... 646

Decanol (USP) ........................... 646

Deuterium Oxide (USP) ...................... 646

Devarda’s Alloy (USP) ...................... 646

Dextran, High Molecular Weight (USP) .............186, 646

Dextrin (USP) ............................ 647

3,3’-Diaminobenzidine Hydrochloride (USP) .......... 647

2,3-Diaminonaphthalene (USP) .................. 647

Diatomaceous Earth, Flux-Calcined (USP) ........... 648

Diatomaceous Earth, Silanized (USP) .............. 648

Diatomaceous Silica, Calcined .................. 648

Diaveridine (USP) ......................... 1239

2,6-Dibromoquinone-chlorimide (USP) ............. 648

Dibutylamine (USP) ........................ 648

Dibutyl Phthalate (USP) ...................... 649

2,5-Dichloroaniline (USP) ..................... 649

2,6-Dichloroaniline (USP) ..................... 649

o-Dichlorobenzene (USP) ..................... 649

Dichloroﬂuorescein (USP) ..................... 650

Dichloroﬂuoromethane (USP) ................... 650

2,4-Dichloro-1-naphthol (USP) .................. 650

2,6-Dichlorophenol-indophenol Sodium (USP) ......... 650

2,6-Dichlorophenylacetic Acid (USP) .............. 650

Dicyclohexylamine (USP) .....................651, 1803

Diethylamine (USP) ........................ 651

N,N-Diethylaniline (USP) ..................... 651

Diethylene Glycol (USP) ..................... 651

Diethylene Glycol Succinate Polyester (USP) .......... 652

Diethylenetriamine (USP) ..................... 652

Di(2-ethylhexyl)phthalate (USP) ................. 652

Digitonin (USP) .......................... 652

Digoxigenin (USP) ......................... 1803

Digoxigenin Bisdigitoxoside (USP) ............... 1803

10,11-Dihydrocarbamazepine (USP) ............... 652

Dihydroquinidine Hydrochloride (USP) ............. 653

Dihydroquinine (USP) ....................... 653

2,5-Dihydroxybenzoic Acid (USP) ................ 653

Diiodoﬂuorescein (USP) ...................... 653

Diisodecyl Phthalate (USP) .................... 654

Diisopropyl Ether (USP) ......................654, 901

Diisopropylamine (USP) ...................... 654

Diisopropylethylamine (USP) ................... 654

2,5-Dimethoxybenzaldehyde (USP) ............... 654

1,2-Dimethoxyethane (USP) ................... 655

(3,4-Dimethoxyphenyl)-acetonitrile (USP) ........... 655

Dimethyl Phthalate (USP) ..................... 655

Dimethyl Sulfone (USP) ...................... 655

Dimethyl Sulfoxide, Spectrophotometric Grade (USP) .... 655

N,N-Dimethylacetamide (USP) ..................656, 1535

p-Dimethylaminobenzaldehyde (USP) .............. 656

2,6-Dimethylaniline (USP) .................... 656

N,N-Dimethylaniline (USP) .................... 656

3,4-Dimethylbenzophenone (USP) ................ 657

5,5-Dimethyl-1,3-cyclohexanedione (USP) ........... 657

Dimethylformamide (USP) .................... 657

N,N-Dimethylformamide Diethyl Acetal (USP) ......... 657

N,N-Dimethyl-1-naphthylamine (USP) .............. 657

N,N-Dimethyloctylamine (USP) ................. 658

2,6-Dimethylphenol (USP) .................... 658

N,N-Dimethyl-p-phenylenediamine Dihydrochloride (USP) .. 658

m-Dinitrobenzene (USP) ...................... 658

3,5-Dinitrobenzoyl Chloride (USP) ................ 659

2,4-Dinitrochlorobenzene (USP) ................. 659

2,4-Dinitrophenylhydrazine (USP) ................901, 1535

Dioxane (USP) ........................... 902

Diphenyl Ether (USP) ....................... 902

Diphenylamine (USP) ....................... 902

Diphenylcarbazide (USP) ..................... 902

Diphenylcarbazone (USP) ..................... 902

2,2-Diphenylglycine (USP) .................... 902

Dipropyl Phthalate (USP) ..................... 903

4,4’-Dipyridyl Dihydrochloride (USP) .............. 903

5,5’-Dithiobis(2-nitrobenzoic Acid) (USP) ........... 903

Dithiothreitol (USP) ........................ 903

Dithizone (USP) .......................... 903

1-Dodecanol (USP) ......................... 903

n-Eicosane (USP) .......................... 904

Eicosanol (USP) .......................... 904

Eosin Y (Eosin Yellowish Y) (USP) ............... 904

Epiandrosterone (USP) ....................... 904

Equilenin (USP) .......................... 904

Eriochrome Black T–Sodium Chloride Indicator (USP) .... 1239

Eriochrome Cyanine R (USP) ................... 904

Ethanesulfonic Acid (USP) .................... 905

Pharmacopeial Forum

1886

INDEX Vol. 32(6) [Nov.–Dec. 2006]

Index

2-Ethoxyethanol (USP) ...................... 905

Ethyl Acetate (USP) ........................ 905

Ethyl Acrylate (USP) ....................... 905

Ethyl Benzoate (USP) ....................... 905

Ethyl Cyanoacetate (USP) ..................... 906

Ethyl Ether (USP) ......................... 906

Ethyl Ether, Anhydrous (USP) .................. 906

Ethyl Salicylate (USP) ....................... 906

2-Ethylaminopropiophenone Hydrochloride (USP) ....... 906

4-Ethylbenzaldehyde (USP) .................... 906

Ethylbenzene (USP) ........................ 907

Ethylene Dichloride (USP) .................... 907

Ethylene Glycol (USP) ...................... 907

1-Ethylquinaldinium Iodide (USP) ................ 907

Fast Blue B Salt (USP) ...................... 907

Fast Blue BB Salt (USP) ..................... 908

Ferric Chloride (USP) ....................... 908

Ferric Nitrate (USP) ........................ 908

Ferric Sulfate (USP) ........................ 908

Ferrous Sulfate (USP) ....................... 909

Fluorene (USP) ........................... 909

9-Fluorenylmethyl Chloroformate (USP) ............ 909

Fluorescamine (USP) ........................ 909

4’-Fluoroacetophenone (USP) ................... 909

Formamide (USP) ......................... 909

Formic Acid (USP) ......................... 910

Formic Acid, 96 Percent (USP) .................. 910

Fuchsin, Basic (USP) ....................... 910

Gadolinium (Gd III) Acetate Hydrate (USP) .......... 910

Gitoxin (USP) ............................ 910

D-Gluconic Acid, 50 Percent in Water (USP) .......... 911

Glucose (USP) ........................... 911

D-Glucuronolactone (USP) .................... 911

Glycerin (USP) ........................... 911

Glycolic Acid (USP) ........................ 911

Gold Chloride (USP) ........................ 911

Guaiacol (USP) ........................... 912

Guanidine Hydrochloride (USP) .................912, 1803

Guanine Hydrochloride (USP) .................. 912

Hematein (USP) .......................... 912

Hematoxylin (USP) ........................ 912

n-Heptane,Chromatographic (USP) ................ 659

Hexadecyl Hexadecanoate (USP) ................. 913

Hexamethyldisilazane (USP) ................... 913

Hexamethyleneimine (USP) .................... 913

n-Hexane (USP) .......................... 913

Hexane, Solvent (USP) ...................... 913

Hexanitrodiphenylamine (USP) .................. 914

Hexanophenone (USP) ....................... 914

Hydrazine Hydrate, 85% in Water (USP) ............186, 914

Hydrazine Dihydrochloride (USP) ................ 914

Hydriodic Acid (USP) ....................... 914

Hydrochloric Acid (USP) ..................... 915

Hydrochloric Acid, Diluted (USP) ................ 915

Hydroﬂuoric Acid (USP) ..................... 915

Hydrogen Peroxide, 10 Percent (USP) .............. 1535

Hydrogen Peroxide, 30 Percent (USP) .............. 915

Hydrogen Sulﬁde (USP) ...................... 915

Hydroquinone (USP) ........................ 915

3’-Hydroxyacetophenone (USP) ................. 916

4’-Hydroxyacetophenone (USP) ................. 916

p-Hydroxybenzoic Acid (USP) .................. 916

4-Hydroxybenzoic Acid Isopropyl Ester (USP) ......... 916

1-Hydroxybenzotriazole Hydrate (USP) ............. 916

2-Hydroxybenzyl Alcohol (USP) ................. 916

4-Hydroxyisophthalic Acid (USP) ................917, 1536

Hydroxylamine Hydrochloride (USP) .............. 917

Hydroxy Naphthol Blue (USP) .................. 917

D-a-Hydroxyphenylglycine (USP) ................ 917

4-(4-Hydroxyphenyl)-2-butanone (USP) ............. 917

Hydroxypropyl--cyclodextrin (USP) .............. 1804

8-Hydroxyquinoline (USP) .................... 918

Hypophosphorous Acid, 50 Percent (USP) ........... 918

Imidazole (USP) .......................... 918

Iminostilbene (USP) ........................ 659

Indene (USP) ............................ 918

Inosine (USP) ............................ 918

Inositol (USP) ............................ 918

Iodic Acid (USP) .......................... 919

Iodine (USP) ............................ 919

Iodine Monobromide (USP) .................... 919

Iodine Monochloride (USP) .................... 919

Isobutyl Acetate (USP) ...................... 919

Isobutyl Alcohol (USP) ...................... 919

Isonicotinic Acid (USP) ...................... 920

Isopropyl Alcohol (USP) ..................... 920

Isopropyl Alcohol, Dehydrated (USP) .............. 920

Isopropyl Myristate (USP) ..................... 920

Isopropylamine (USP) ....................... 920

Kerosene (USP) ........................... 921

Lactose (USP) ........................... 921

Lanthanum Chloride (USP) .................... 921

Lead Acetate (USP) ........................ 921

Lead Monoxide (USP) ....................... 921

Lead Nitrate (USP) ......................... 922

Lithium Chloride (USP) ...................... 922

Lithium Hydroxide (USP) ..................... 922

Lithium Metaborate (USP) .................... 922

Lithium Nitrate (USP) ....................... 922

Lithium Percholate (USP) ..................... 922

Lithium Sulfate (USP) ....................... 922

Lithocholic Acid (USP) ...................... 923

Litmus (USP) ............................ 923

L-Lysine (USP) ........................... 923

Magnesium (USP) ......................... 923

Magnesium Acetate (USP) .................... 923

Magnesium Chloride (USP) .................... 923

Magnesium Nitrate (USP) ..................... 924

Magnesium Oxide (USP) ..................... 924

Magnesium Perchlorate, Anhydrous (USP) ........... 924

Magnesium Sulfate (USP) ..................... 924

Magnesium Sulfate, Anhydrous (USP) ............. 924

Maleic Acid (USP) ......................... 924

Manganese Dioxide, Activated (USP) .............. 925

Mercuric Acetate (USP) ...................... 925

Mercuric Bromide (USP) ..................... 925

Mercuric Chloride (USP) ..................... 925

Mercuric Iodide, Red (USP) ................... 925

Mercuric Nitrate (USP) ...................... 925

Mercuric Oxide, Yellow (USP) .................. 926

Mercuric Sulfate (USP) ...................... 926

Mercuric Thiocyanate (USP) ................... 926

Mercury (USP) ........................... 926

Mesityl Oxide (USP) ........................ 926

Metaphosphoric Acid (USP) ................... 926

Methacrylic Acid (USP) ...................... 927

Methanesulfonic Acid (USP) ................... 927

Methanol (USP) .......................... 927

Methoxyethanol (USP) ....................... 927

2-Methoxyethanol (USP) ..................... 927

5-Methoxy-2-methyl-3-indoleacetic Acid (USP) ........ 927

Methyl Acetate (USP) ....................... 927

Methyl 4-Aminobenzoate (USP) ................. 928

Methyl Arachidate (USP) ..................... 928

Methyl Behenate (USP) ...................... 928

Methyl Caprate (USP) ....................... 928

Methyl Caprylate (USP) ...................... 928

Methyl Carbamate (USP) ..................... 929

Methyl Chloroform (USP) ..................... 929

Methyl Erucate (USP) ....................... 929

Methyl Ethyl Ketone (USP) .................... 929

Methyl Green (USP) ........................ 1536

Methyl Heptadecanoate (USP) .................. 929

Methyl Iodide (USP) ........................929, 1536

Methyl Laurate (USP) ....................... 930

Methyl Lignocerate (USP) ..................... 930

Methyl Linoleate (USP) ...................... 930

Methyl Linolenate (USP) ..................... 930

Methyl Methacrylate (USP) .................... 931

Methyl Myristate (USP) ...................... 931

Methyl Oleate (USP) ........................ 931

Methyl Palmitate (USP) ...................... 931

Pharmacopeial Forum

Vol. 32(6) [Nov.–Dec. 2006]

INDEX 1887

Index

Methyl Stearate (USP) ....................... 931

Methyl Sulfoxide (USP) ...................... 932

Methylamine, 40 Percent in Water (USP) ............ 932

p-Methylaminophenol Sulfate (USP) ............... 932

Methylene Blue (USP) ....................... 932

Methylene Chloride (USP) .................... 932

5-5’-Methylenedisalicylic Acid (USP) .............. 932

4-Methyl-2-pentanone (USP) ................... 933

2-Methyl-2-propyl-1,3-propanediol (USP) ............ 933

N-Methylpyrrolidine (USP) .................... 659

Molybdic Acid (USP) ....................... 933

Monochloroacetic Acid (USP) .................. 933

Morpholine (USP) ......................... 933

Naphthalene (USP) ......................... 933

1,3-Naphthalenediol (USP) .................... 934

2,7-Naphthalenediol (USP) .................... 934

2-Naphthalenesulfonic Acid (USP) ................ 934

1-Naphthol (USP) .........................186, 934

2-Naphthol (USP) ......................... 934

p-Naphtholbenzein (USP) ..................... 935

Naphthoresorcinol (USP) ..................... 935

1-Naphthylamine Hydrochloride (USP) ............. 935

2-Napthyl Chloroformate (USP) ................. 935

N-(1-Naphthyl)ethylenediamine Dihydrochloride (USP) .... 935

Nickel (USP) ............................ 935

Nickel Sulfate (USP) ........................ 936

-Nicotinamide Adenine Dinucleotide (USP) .......... 936

Ninhydrin (USP) .......................... 936

Nitric Acid (USP) ......................... 936

Nitric Acid, Diluted (USP) .................... 936

Nitric Acid, Fuming (USP) .................... 936

Nitrilotriacetic Acid (USP) .................... 937

4’-Nitroacetophenone (USP) .................... 937

o-Nitroaniline (USP) ........................ 937

p-Nitroaniline (USP) ........................ 937

Nitrobenzene (USP) ........................ 937

p-Nitrobenzenediazonium Tetraﬂouroborate (USP) ....... 937

4-(p-Nitrobenzyl)pyridine (USP) ................. 938

Nitromethane (USP) ........................ 938

5-Nitro-1,10-phenanthroline (USP) ................ 938

1-Nitroso-2-naphthol (USP) .................... 938

Nitroso R Salt (USP) ........................ 939

Nitrous Oxide Certiﬁed Standard (USP) ............. 939

Nonadecane (USP) ......................... 939

Nonanoic Acid (USP) ....................... 939

1-Nonyl Alcohol (USP) ...................... 1239

n-Octadecane (USP) ........................ 1537

Octadecyl Silane (USP) ...................... 1240

1-Octanol (USP) .......................... 1804

Octanophenone (USP) ....................... 1240

Orange G (USP) .......................... 1240

Orcinol (USP) ............................ 1240

Osmium Tetroxide (USP) ..................... 1241

Oxalic Acid (USP) ......................... 1241

3,3’-Oxydipropionitrile (USP) ................... 1241

Oxygen-Helium Certiﬁed Standard (USP erratum) ....... 1430

Palladium Chloride (USP) ..................... 1241

Pancreatin (USP) .......................... 1241

Para-aminobenzoic Acid (USP) .................. 1241

Paraformaldehyde (USP) ..................... 1242

Pentadecane (USP) ......................... 1242

Pentane (USP) ........................... 1242

Pepsin (USP) ............................ 1242

Perchloric Acid (USP) ....................... 1242

Periodic Acid (USP) ........................ 1243

Phenacetin (USP) .......................... 1243

1,10-Phenanthroline (USP) .................... 1243

Phenol (USP) ............................ 1243

Phenoxybenzamine Hydrochloride (USP) ............ 1243

2-Phenoxyethanol (USP) ..................... 1243

dl-Phenylalanine (USP) ...................... 1244

Phenylhydrazine (USP) ...................... 1244

Phenylhydrazine Hydrochloride (USP) .............660, 1244

Phenyl Isocyanate (USP) ..................... 1244

3-Phenylphenol (USP) ....................... 1245

Phloroglucinol (USP) ....................... 1245

Phosphomolybdic Acid (USP) .................. 1245

Phosphoric Acid (USP) ...................... 1245

Phosphorous Pentoxide (USP) .................. 1245

Phthalazine (USP) ......................... 1245

Phthalic Acid (USP) ........................ 1246

Phthalic Anhydride (USP) ..................... 1246

Phthalimide (USP) ......................... 1246

2-Picoline (USP) .......................... 1246

Picric Acid (USP) ......................... 1246

Picrolonic Acid (USP) ....................... 1246

Pipemidic Acid (USP) ....................... 1247

Piperidine (USP) .......................... 1247

Platinic Chloride (USP) ...................... 1247

Polyethylene Glycol 600 (USP) ................. 1247

Polyethylene Glycol 20,000 (USP) ................ 1247

Polysaccharide Molecular Weight Standards (USP) ...... 1804

Polyvinyl Alcohol (USP) ..................... 1247

Potassium Acetate (USP) ..................... 1248

Potassium Bicarbonate (USP) ................... 1248

Potassium Biphthalate (USP) ................... 1248

Potassium Bisulfate (USP) .................... 1248

Potassium Bromate (USP) ..................... 1248

Potassium Bromide (USP) ..................... 1249

Potassium Carbonate, Anhydrous (USP) ............ 1249

Potassium Chlorate (USP) ..................... 1249

Potassium Chloride (USP) ..................... 1249

Potassium Chromate (USP) .................... 1249

Potassium Cyanide (USP) ..................... 1249

Potassium Dichromate (USP) ................... 1249

Potassium Ferricyanide (USP) .................. 1250

Potassium Ferrocyanide (USP) .................. 1250

Potassium Hydroxide (USP) ................... 1250

Potassium Iodate (USP) ...................... 1250

Potassium Iodide (USP) ...................... 1250

Potassium Nitrate (USP) ...................... 1250

Potassium Nitrite (USP) ...................... 1250

Potassium Perchlorate (USP) ................... 1251

Potassium Periodate (USP) .................... 1251

Potassium Permanganate (USP) ................. 1251

Potassium Persulfate (USP) .................... 1251

Potassium Phosphate, Dibasic (USP) ............... 1251

Potassium Phosphate, Monobasic (USP) ............ 1251

Potassium Phosphate, Tribasic (USP) .............. 1252

Potassium Pyroantimonate (USP) ................. 1252

Potassium Pyrophosphate (USP) ................. 1252

Potassium Pyrosulfate (USP) ................... 1252

Potassium Sodium Tartrate (USP) ................ 1252

Potassium Sulfate (USP) ...................... 1252

Potassium Tellurite (USP) ..................... 1253

Potassium Thiocyanate (USP) ................... 1253

Propionaldehyde (USP) ...................... 1253

Propionic Anhydride (USP) .................... 1253

n-Propyl Alcohol (USP) ...................... 1253

Pullulan Standards (USP) ..................... 1537

Purine (USP) ............................ 1253

Pyrazole (USP) ........................... 1254

Pyrene (USP) ............................ 1254

Pyridine (USP) ........................... 1254

Pyridine, Dried (USP) ....................... 1254

Pyridoxal Hydrochloride (USP) .................. 1254

Pyridoxal 5-Phosphate (USP) ................... 1254

Pyridoxamine Dihydrochloride (USP) .............. 1255

1-(2-Pyridylazo)-2-naphthol (USP) ................ 1255

Pyrogallol (USP) .......................... 1255

Pyrrole (USP) ............................ 1255

Pyruvic Acid (USP) ........................ 1255

Quinhydrone (USP) ........................ 1256

Resazurin (Sodium) (USP) .................... 1256

Rhodamine B (USP) ........................ 1256

Rose Bengal Sodium (USP) .................... 1256

Ruthenium Red (USP) ....................... 1257

Safranin O (USP) .......................... 1257

Salicylaldehyde (USP) ....................... 1257

Selenious Acid (USP) ....................... 1257

Selenium (USP) ........................... 1258

Selenomethionine (USP) ...................... 1258

Pharmacopeial Forum

1888

INDEX Vol. 32(6) [Nov.–Dec. 2006]

Index

Silica Gel, Octadecylsilanized Chromatographic (USP) .... 660

Silicic Acid (USP) ......................... 1258

Silicon Carbide (USP) ....................... 1259

Silicotungstic Acid, n-Hydrate (USP) .............. 1259

Silver Diethyldithiocarbamate (USP) ............... 1259

Silver Nitrate (USP) ........................ 1259

Silver Oxide (USP) ......................... 1259

Sodium (USP) ........................... 1260

Sodium Acetate (USP) ....................... 1260

Sodium Acetate, Anhydrous (USP) ............... 1260

Sodium Arsenite (USP) ...................... 1260

Sodium Azide (USP) ........................ 1260

Sodium Bicarbonate (USP) .................... 1261

Sodium Bisulﬁte (USP) ...................... 1261

Sodium Bitartrate (USP) ...................... 1261

Sodium Borate (USP) ....................... 1261

Sodium Borohydride (USP) .................... 1261

Sodium Bromide (USP) ...................... 1262

Sodium Carbonate, Anhydrous (USP) .............. 1262

Sodium Chloride (USP) ...................... 1262

Sodium Chromate (USP) ..................... 1262

Sodium Citrate Dihydrate (USP) ................. 1537

Sodium Cobaltinitrite (USP) ................... 1262

Sodium Cyanide (USP) ...................... 1263

Sodium 1-Decanesulfonate (USP) ................ 1263

Sodium Dichromate (USP) .................... 1263

Sodium Diethyldithiocarbamate (USP) ............. 1263

Sodium Dodecyl Sulfate (USP) .................. 1263

Sodium Ferrocyanide (USP) ................... 1263

Sodium Fluoride (USP) ...................... 1264

Sodium Glycocholate (USP) ................... 1264

Sodium 1-Heptanesulfonate (USP) ................ 1264

Sodium 1-Hexanesulfonate (USP) ................ 1264

Sodium Hydrosulﬁte (USP) .................... 1264

Sodium Hydroxide (USP) ..................... 1265

Sodium Hypochlorite Solution (USP) .............. 1265

Sodium Metabisulﬁte (USP) ................... 1265

Sodium Metaperiodate (USP) ................... 1265

Sodium Methoxide (USP) ..................... 1265

Sodium Molybdate (USP) ..................... 1266

Sodium Nitrate (USP) ....................... 1266

Sodium Nitrite (USP) ....................... 1266

Sodium Nitroferricyanide (USP) ................. 1266

Sodium 1-Octanesulfonate (USP) ................. 1266

Sodium Oxalate (USP) ....................... 1266

Sodium (tri) Pentacyanoamino Ferrate (USP) .......... 1267

Sodium 1-Pentanesulfonate (USP) ................ 1267

Sodium Perchlorate (USP) ..................... 1267

Sodium Peroxide (USP) ...................... 1267

Sodium Phosphate, Dibasic (USP) ................ 1267

Sodium Phosphate, Dibasic, Anhydrous (USP) ......... 1268

Sodium Phosphate, Dibasic, Dodecahydrate (USP) ...... 1268

Sodium Phosphate, Monobasic (USP) .............. 1268

Sodium Phosphate, Tribasic (USP) ................ 1268

Sodium Pyrophosphate (USP) .................. 1268

Sodium Pyruvate (USP) ...................... 1268

Sodium Salicylate (USP) ..................... 1269

Sodium Selenite (USP) ...................... 1269

Sodium Sulfate (USP) ....................... 1269

Sodium Sulfate, Anhydrous (USP) ................ 1269

Sodium Sulﬁde (USP) ....................... 1270

Sodium Sulﬁte, Anhydrous (USP) ................ 1270

Sodium Tartrate (USP) ....................... 1270

Sodium Tetraphenylborate (USP) ................. 1270

Sodium Thioglycolate (USP) ................... 1270

Sodium Thiosulfate (USP) ..................... 1270

Sodium Tungstate (USP) ..................... 1271

Stachyose Tetrahydrate (USP) .................. 1537

Stannous Chloride (USP) ..................... 1271

Starch, Soluble (USP) ....................... 1271

Stearic Acid (USP) ......................... 1271

Stearyl Alcohol (USP) ....................... 1271

Strontium Acetate (USP) ..................... 1271

Strontium Hydroxide (USP) .................... 1272

Strychnine Sulfate (USP) ..................... 1272

Sudan III (USP) .......................... 1273

Sudan IV (USP) .......................... 1273

Sulfamic Acid (USP) ........................ 1273

Sulfanilamide (USP) ........................ 1273

Sulfanilic Acid (USP) ....................... 1273

Sulfosalicylic Acid (USP) ..................... 1273

Sulfuric Acid (USP) ........................ 1274

Sulfuric Acid, Fuming (USP) ................... 1274

Sulfurous Acid (USP) ....................... 1274

Tannic Acid (USP) ......................... 1274

Tetrabutylammonium Bromide (USP) .............. 1274

Tetrabutylammonium Hydrogen Sulfate (USP) ......... 1274

Tetrabutylammonium Hydroxide, 1.0 M in Methanol (USP) . 1275

Tetrabutylammonium Hydroxide, 40 Percent in Water (USP) . 1275

Tetrabutylammonium Iodide (USP) ...............1275, 1804

Tetrabutylammonium Phosphate (USP) ............. 1275

Tetracosane (USP) ......................... 1275

Tetradecane (USP) ......................... 1275

Tetraethylene Glycol (USP) .................... 1276

Tetraethylenepentamine (USP) .................. 1276

Tetraheptylammonium Bromide (USP) ............. 1276

Tetrahydrofuran (USP) ....................... 1276

Tetrahydro-2-furnancarboxylic Acid (USP) ........... 1276

1,2,3,4-Tetrahydronaphthalene (USP) .............. 1277

Tetramethylammonium Bromide (USP) ............. 1277

Tetramethylammonium Chloride (USP) ............. 1277

Tetramethylammonium Hydroxide (USP) ............ 1277

Tetramethylammonium Hydroxide, Pentahydrate (USP) .... 1277

Tetramethylammonium Hydroxide Solution in Methanol (USP) 1278

Tetramethylammonium Nitrate (USP) .............. 1278

4-4’-Tetramethyldiaminodiphenylmethane (USP) ........ 1278

Tetramethylsilane (USP) ...................... 1278

Theobromine (USP) ........................ 1278

Thiazole Yellow (USP) ...................... 1278

Thioacetamide (USP) ....................... 1279

2-Thiobarbituric Acid (USP) ................... 1279

2,2’-Thiodiethanol (USP) ..................... 1279

Thiourea (USP) ........................... 1279

Thorium Nitrate (USP) ....................... 1279

Thromboplastin (USP) ....................... 1279

Thymol (USP) ........................... 1280

Tin (USP) .............................. 1280

Titanium Tetrachloride (USP) ................... 1280

Titanium Trichloride (USP) .................... 1280

o-Tolidine (USP) .......................... 1280

Tolualdehyde (USP) ........................ 1281

p-Tolualdehyde (USP) ....................... 1281

Toluene (USP) ........................... 1281

p-Toluenesulfonic Acid (USP) .................. 1281

p-Toluenesulfonyl-L-arginine Methyl Ester Hydrochloride

(USP)

............................... 186

p-Toluic Acid (USP) ........................ 1281

o-Toluidine (USP) ......................... 1282

p-Toluidine (USP) ......................... 1282

n-Triacontane (USP) ........................ 1282

Tributyl Phosphate (USP) ..................... 1282

Tributyrin (USP) .......................... 1282

Trichloroacetic Acid (USP) .................... 1282

Trichloroﬂuoromethane (USP) .................. 1283

n-Tricosane (USP) ......................... 1283

Triethylamine (USP) ........................ 1283

Triethylamine Hydrochloride (USP) ............... 1283

Triethylene Glycol (USP) ..................... 1284

Triﬂuoroacetic Acid (USP) .................... 1284

Triﬂuoroacetic Anhydride (USP) ................. 1284

2,2,2-Triﬂuoroethanol (USP) ................... 1284

5-(Triﬂuoromethyl)uracil (USP) ................. 1285

Trimethylacethydrazide Ammonium Chloride (USP) ..... 1285

2,2,4-Trimethylpentane (USP) .................. 1285

2,4,6-Trimethylpyridine (USP) .................. 1285

N-(Trimethylsilyl)-imidazole (USP) ............... 1285

2,4,6-Trinitrobenzenesulfonic Acid (USP) ............ 1285

Trioctylphosphine Oxide (USP) ................. 1286

1,3,5-Triphenylbenzene (USP) .................. 1286

Triphenylmethane (USP) ..................... 1286

Triphenylmethanol (USP) ..................... 1286

Triphenyltetrazolium Chloride (USP) .............. 1286

Pharmacopeial Forum

Vol. 32(6) [Nov.–Dec. 2006]

INDEX 1889

Index

Tris(2-aminoethyl)amine (USP) .................. 1287

Tris(hydroxymethyl)aminomethane (USP) ............ 1287

Tropaeolin OO (USP) ....................... 1287

L-Tryptophane (USP) ........................ 1287

Tubocurarine Chloride (USP) ................... 1287

Tungstic Acid (USP) ........................ 1538

Uracil (USP) ............................ 1288

Uranyl Acetate (USP) ....................... 1288

Urea (USP) ............................. 1288

Urethane (USP) ........................... 1288

Uridine (USP) ............................ 1288

Valeric Acid (USP) ......................... 1288

Valerophenone (USP) ....................... 1289

Vanadium Pentoxide (USP) .................... 1289

Vanadyl Sulfate (USP) ....................... 1289

Vinyl Acetate (USP) ........................ 1289

1-Vinyl-2-pyrrolidone (USP) ................... 1290

Wright’s Stain (USP) ........................ 1290

Xanthine (USP) ........................... 1290

Xanthydrol (USP) ......................... 1290

Xylene (USP) ............................ 1290

o-Xylene (USP) ........................... 1291

p-Xylene (USP) ........................... 1291

Xylene Cyanole FF (USP) ..................... 1291

Xylose (USP) ............................ 1291

Zinc (USP) ............................. 1291

Zinc Acetate (USP) ......................... 1291

Zirconyl Nitrate (USP) ....................... 1292

Indicators and Indicator Test Papers

Methyl Green-Iodomercurate Paper (USP)

........... 1538

Test Solutions

Acetic Acid, Strong, TS (USP)

.................. 1538

Ammonium Pyrrolidinedithiocarbamate, Saturated, TS (USP) 1538

Dicyclohexylamine Acetate (USP) ................ 1805

Volumetric Solutions

Bismuth Nitrate, 0.01 mol/L

................... 1292

Magnesium Chloride, 0.01 M ................... 1292

Mercuric Nitrate, Tenth Molar (0.1 M) (USP) ......... 1805

Potassium Hydroxide, Normal (1 N) (USP) ...........660, 940

Sodium Hydroxide, Normal (1 N) (USP) ............ 940

Sodium Tetraphenylboron, Fiftieth Molar (0.02 M) (USP) .. 1807

Sodium Thiosulfate, Tenth-Normal (0.1 N) (USP) ....... 940

REFERENCE TABLES

Container Speciﬁcations .......................187, 661, 941, 1299, 1539, 1809

Description and Solubility (USP) ..................188, 662, 942, 1301, 1541, 1811

GENERAL SUBJECTS

Alendronic Acid Tablets: Notice of Postponement ........ 1406

Amifostine for Injection: Notice of Revision ............ 1407

Call for High Priority Monographs for Drug Substances and

Products, and Excipients

......................20, 249, 730, 1014, 1410, 1640

Canceled Revision Proposals .....................204, 678, 962, 1323, 1567, 1837

Catalog to be Removed from Pharmacopeial Forum Print

Publication

..............................1407, 1638

Changes Adopted for the Rules and Procedures of the 2005–2010

Council of Experts

..........................730, 1014, 1410, 1640

Comments on Residual Solvents due June 1, 2006 ........ 727

Coordination of Ofﬁcial New Monographs, Revisions, and USP

Reference Standards

......................... 727

Coordination of PF Submissions and New USP Reference

Standards

...............................1010, 1406

Dietary Supplements—Monographs ................. 160

Errata for Spanish Edition of USP–NF to Appear on Website .. 1637

Errata List for USP29–NF24

Ammonium Sulfate

......................... 1035

Bisoprolol Fumarate and Hydrochlorothiazide Tablets ..... 291

Carbomer Homopolymer ..................... 37

Clarithromycin Extended-Release Tablets ............ 748

Dextroamphetamine Sulfate Tablets ............... 1035

Dronabinol Capsules ........................ 1430

Elastomeric Closures for Injections h381i ............ 292

Glutamine .............................. 1430

Glyceryl Monolinoleate ...................... 37

Helium ................................ 291

Insulin Assays h121i ........................ 1661

Metformin Hydrochloride Tablets ................ 1430

Nitrogen ............................... 293

Nitrogen 97 Percent ........................ 293

Nitrous Oxide ............................ 292

Ondansetron Orally Disintegrating Tablets ........... 1430

Oxygen-Helium Certiﬁed Standard ................ 1430

Prednisolone Tablets ........................ 1430

Ranitidine Injection ........................ 1660

Ranitidine Oral Solution ...................... 1660

Ranitidine in Sodium Chloride Injection ............. 1661

Ranitidine Tablets ......................... 1661

Saccharin Sodium ......................... 1035

Succinylcholine Chloride for Injection .............. 1661

Tiamulin Fumarate ......................... 37

Compound Undecylenic Acid Ointment ............. 1430

Sterile Water for Inhalation .................... 37

Sterile Water for Injection ..................... 37

Sterile Water for Irrigation ..................... 37

Sterile Puriﬁed Water ....................... 37

Yohimbine Injection ........................ 748

Expert Committee Designations ...................12, 240, 720, 1004, 1400, 1630

Expert Committee Summaries Available on the USP

Web Site

...............................18, 246, 727

Fifth Interim Revision ......................... 1419

First Interim Revision ......................... 33

Fourth Interim Revision ........................ 1023

General Chapter h1i and h905i Postponements—Clariﬁcation .. 18, 246

Harmonization .............................207, 681, 965, 1327, 1571

Anhydrous Dibasic Calcium Phosphate (USP) ......... 1332

Copovidone (NF) .......................... 1843

Dibasic Calcium Phosphate Dihydrate (USP) .......... 1329

Edetate Calcium Disodium (USP) ................ 1335

Hypromellose (USP) ........................ 1573

Anhydrous Lactose (NF) ..................... 1847

How to Submit Comments ......................28, 248, 729, 1013, 1409, 1639

How to Use PF .............................9, 237, 717, 1001, 1397, 1627

Immediate IRA Commentary: Indocyanine Green ......... 1407

Immediate IRA Commentary: Nitrofurantoin Capsules ...... 1407

Immediate IRA Commentary Residual Solvents: General Notices

and General Chapter h467i—Implementation Date Delayed

.. 1011

Immediate IRA for Nitrofurantoin Capsules ............ 1011

Immediate IRA for Tablets Containing at Least Three of the

Following—Acetaminophen and Salts of Chlorpheniramine,

Dextromethorphan, and Pseudoephedrine

............. 1011

Immediate IRA for Zinc Sulfate Tablets .............. 1011

Implementation Period for Upcoming Ofﬁcial Revisions to

the USP–NF Extended

.......................1010, 1406, 1637

In Memoriam .............................. 1636

In-Process Revision ..........................749, 1037, 1491, 1663, 1779

Interim Revision Announcements

First Interim Revision

....................... 33

Second Interim Revision ...................... 259

Third Interim Revision ....................... 739

Fourth Interim Revision ...................... 1023

Fifth Interim Revision ....................... 1419

Sixth Interim Revision ....................... 1649

International Correspondence .....................28, 248, 729, 1013, 1408, 1639

New Pharmacopeial Forum Public Review and Comment Period

Deadlines

...............................29, 248, 729, 1013, 1409, 1639

Nomenclature .............................215, 695, 973, 1371, 1597, 1870

Notice of Correction to Helium, Nitrous Oxide, Nitrogen, and

Nitrogen 97 Percent Monographs

................. 246

Pending Proposals ...........................190, 663, 943, 1302, 1542, 1812

PF Online Launches New ‘‘My PF’’ Product Enhancement ... 246

Pharmacopeial Education Courses ..................28, 247, 727, 1012, 1408, 1638

Pharmacopeial Forum Public Review and Comment Period

Deadlines

............................... 1013

Policies and Announcements

Alendronic Acid Tablets: Notice of Postponement

....... 1406

Amifostine for Injection: Notice of Revision .......... 1407

Call for High Priority Monographs for Drug Substances and

Products, and Excipients

....................20, 249, 730, 1014, 1410, 1640

Catalog to be Removed from Pharmacopeial Forum Print

Publication

............................1407, 1638

Pharmacopeial Forum

1890

INDEX Vol. 32(6) [Nov.–Dec. 2006]

Index

Changes Adopted for the Rules and Procedures of the 2005–2010

Council of Experts

.......................730, 1014, 1410, 1640

Comments on Residual Solvents due June 1, 2006 ....... 727

Coordination of Ofﬁcial New Monographs, Revisions, and USP

Reference Standards

....................... 727

Coordination of PF Submissions and New USP Reference

Standards

.............................1010, 1406

Errata for Spanish Edition of USP–NF to Appear on Website 1637

Expert Committee Summaries Available on the USP

Web Site

.............................18, 246, 727

General Chapter h1i and h905i Postponements—Clariﬁcation 18, 246

How to Submit Comments ....................28, 248, 729, 1013, 1409, 1639

Immediate IRA Commentary: Indocyanine Green ....... 1407

Immediate IRA Commentary: Nitrofurantoin Capsules .... 1407

Immediate IRA Commentary Residual Solvents: General Notices

and General Chapter h467i—Implementation Date Delayed

1011

Immediate IRA for Nitrofurantoin Capsules .......... 1011

Immediate IRA for Tablets Containing at Least Three of the

Following—Acetaminophen and Salts of Chlorpheniramine,

Dextromethorphan, and Pseudoephedrine

.......... 1011

Immediate IRA for Zinc Sulfate Tablets ............. 1011

Implementation Period for Upcoming Ofﬁcial Revisions to the

USP–NF Extended

.......................1010, 1406, 1637

In Memoriam ............................ 1636

International Correspondence ...................28, 248, 729, 1013, 1408, 1639

New Pharmacopeial Forum Public Review and Comment Period

Deadlines

.............................29, 248, 729, 1013, 1409, 1639

Notice of Correction to Helium, Nitrous Oxide, Nitrogen, and

Nitrogen 97 Percent Monographs

............... 246

PF Online Launches New ‘‘My PF’’ Product Enhancement .. 246

Pharmacopeial Education Courses ................28, 247, 727, 1012, 1408, 1638

Pharmacopeial Forum Public Review and Comment Period

Deadlines

............................. 1013

Priority New Monograph Items ..................730, 1014, 1410, 1640

Publications and Comment Schedule ...............29, 249, 1014

Publication Schedules .......................30, 249, 730, 1014

Revision Bulletins ......................... 1406

Revisions to Goldenseal Monographs .............. 18

Staff Promotions Announced ................... 726

Standards Divison Reorganized .................. 726

Stimuli Articles to Be Posted on USP’s Website ........ 1638

USP30–NF25 to be Printed as a Three-Volume Set ...... 1406

USP Announces the Chairs of the Information Expert

Committees

............................ 18

USP Annual Scientiﬁc Meeting 2006 ..............1011, 1407

USP Director of Executive Secretariat Named ......... 18

USP Discontinues Use of Intent to Comment Form ...... 1637

USP Information Expert Committee Members Elected .... 1011

USP Issues Notice of Retraction for Residual Solvents .... 18, 246

USP Issues Interim Revision Announcement for General Chapter

h231i Heavy Metals

....................... 727

USP Opens Facility in India ................... 727

USP Partners With the Indian Pharmacopoeia ......... 1636

USP Rules and Procedures of the Council of Experts Revised,

Reﬂecting Changes to the Standards-Setting Process

.... 1637

USP Seeks Submission of Proposals for Stability Indicating

Assay Procedures for Steroids

................. 19, 247

USP to Publish Food Chemicals Codex ............. 1636

Visit the USP Web Site at hhttp://www.usp.orgi ........28, 248, 729, 1013, 1408, 1639

Previews ................................209, 683, 967, 1339

Pending Proposals ...........................190, 663, 943, 1302, 1542, 1812

Priority New Monograph Items ...................730, 1014, 1410, 1640

Publications and Comment Schedule ................29, 249, 1014

Publication Schedules .........................30, 249, 730, 1014

Revision Bulletins ........................... 1406

Revisions to Goldenseal Monographs ................ 18

Second Interim Revision ....................... 259

Section Descriptions ..........................10, 238, 718, 1398

Sixth Interim Revision ........................ 1649

Staff Directory .............................14, 241, 721, 1005, 1402, 1632

Staff Promotions Announced ..................... 726

Standards Development ........................5, 233, 713, 997, 1393, 1623

Standards Divison Reorganized ................... 726

Stimuli to the Revision Process

Bioassay Glossary, Robert Singer, David M. Lansky, and Walter

W. Hauck

............................. 1359

Comparative Study of the Chromatographic and Bioassay

Procedure for the Determination of Vasopressin Potency

.. 1856

Correction Formula for the Boiling Point Temperatures in USP

General Chapter Distilling Range h721i,

.......... 1353

Determination of Signal-to-Noise Ratio in the Establishment of

Quantitation Limit Requirements for Chromatographic

Methods in USP Monographs—Approaches for Calculation

and Implementation

....................... 1862

Instructions to Authors .......................213, 687, 971, 1343, 1583

In Vitro Release: Collaborative Study Using the Vertical

Diffusion Cell,

......................... 1590

Monograph Redesign Proposal .................. 1865

Performance Test for Topical and Transdermal Dosage Forms, 1586

Preparations for Nebulization: Characterization, ........ 1348

Proposed Monograph for Piroxicam Topical Cream 3%, ... 1344

Proposed Revisions to USP Standards for Containers—Glass, 1366

The Role of Container–Closure Systems in Stability Testing for

Climate Zone IV,

........................ 688

USP Advisory Panel on the USP Performance Test for Topical

and Transdermal Dosage Forms,

............... 1584

Stimuli Articles to Be Posted on USP’s Website .......... 1638

Third Interim Revision ........................ 739

USP30–NF25 to be Printed as a Three-Volume Set ........ 1406

USP Announces the Chairs of the Information Expert Committees 18

USP Annual Scientiﬁc Meeting 2006 ................1011, 1407

USP Director of Executive Secretariat Named ........... 18

USP Discontinues Use of Intent to Comment Form ........ 1637

USP Information Expert Committee Members Elected ...... 1011

USP Issues Notice of Retraction for Residual Solvents ...... 18, 246

USP Issues Interim Revision Announcement for General Chapter

h231i Heavy Metals

......................... 727

USP Opens Facility in India ..................... 727

USP Partners With the Indian Pharmacopoeia ........... 1636

USP Rules and Procedures of the Council of Experts Revised,

Reﬂecting Changes to the Standards-Setting Process

...... 1637

USP Seeks Submission of Proposals for Stability Indicating Assay

Procedures for Steroids

....................... 19, 247

USP to Publish Food Chemicals Codex ............... 1636

Visit the USP Web Site at hhttp://www.usp.orgi ..........28, 248, 729, 1013, 1408, 1639

Pharmacopeial Forum

Vol. 32(6) [Nov.–Dec. 2006]

INDEX 1891

Index

[Note—This index covers Vol. 33 No. 1, pp. 1–151; Vol. 33 No.

2 pp. 151–339; Vol. 33 No. 3 pp. 341–590; Vol. 33 No. 4 pp.

591–822; Vol. 33 No. 5 pp. 823–1110; Vol. 33 No. 6 pp. 1111–

1340]

GENERAL NOTICES AND REQUIREMENTS

Tests and Assays (USP) ........................ 857

MONOGRAPHS

Acarbose ................................ 388

Acellular Dermal Matrix (USP) ................... 898

Acetaminophen Extended-Release Tablets (USP) ......... 183

Acitretin (USP) ............................. 390

Acitretin Capsules (USP) ....................... 392

Agar (NF) ................................ 702

Alprazolam (USP) ........................... 868

Alprazolam Tablets .......................... 41

Alumina, Magnesia, Calcium Carbonate, and Simethicone Tablets

(USP)

................................. 870

Alumina, Magnesia, Calcium Carbonate, and Simethicone

Chewable Tablets (USP)

...................... 871

Alumina, Magnesia, and Simethicone Oral Suspension (USP) .. 871

Alumina, Magnesia, and Simethicone Tablets (USP) ....... 871

Alumina, Magnesia, and Simethicone Chewable Tablets (USP) . 871

Amiloride Hydrochloride and Hydrochlorothiazide Tablets (USP) 636

Arginine Capsules (USP) ....................... 1160

Arginine Tablets (USP) ........................ 1161

Atovaquone (USP) ........................... 637

Avobenzone (USP) .......................... 872

Azithromycin (USP) .......................... 1145

Aztreonam (USP) ........................... 872

Bacitracin (USP) ............................ 873

Bacitracin Zinc (USP) ......................... 875

Baclofen (USP) ............................ 211

Benazepril Hydrochloride Tablets (USP) ..............637, 1145

Benzonatate Capsules (USP) ..................... 394

Bicalutamide (USP) .......................... 876

Bismuth Subsalicylate Magma (USP) ................ 638

Bismuth Subsalicylate Oral Suspension (USP) ........... 41

Bisoprolol Fumarate Tablets (USP) ................. 183

Bupropion Hydrochloride (USP) ...................211, 638

Bupropion Hydrochloride Extended-Release Tablets

(USP)

.................................42, 184, 639, 1145

Bupropion Hydrochloride Tablets (USP) .............. 211

Calcitonin Salmon (USP) ....................... 878

Calcitriol (USP) ............................ 44

Calcium Carbonate and Magnesia Chewable Tablets (USP) ... 212

Calcium Carbonate and Magnesia Tablets (USP) ......... 211

Calcium Carbonate, Magnesia, and Simethicone Tablets (USP) . 888

Calcium Carbonate, Magnesia, and Simethicone Chewable Tablets

(USP)

................................. 888

Calcium Silicate (NF) ......................... 484

Calcium Silicate (NF erratum) .................... 863

Carbachol (USP) ............................ 213

Carbachol Intraocular Solution (USP) ................ 213

Carbachol Ophthalmic Solution (USP) ............... 214

Carmellose (USP) ........................... 537

Carvedilol Tablets (USP) ....................... 888

Cefaclor Chewable Tablets (USP) .................. 641

Cefdinir (USP) ............................. 1162

Chamomile (USP) ........................... 688

Ciclopirox (USP) ........................... 642

Ciclopirox Olamine (USP) ...................... 643

Cilostazol Tablets (USP) ....................... 395

Citalopram Hydrobromide (USP) .................. 214

Citalopram Hydrobromide (USP erratum) ............. 1155

Citalopram Tablets (USP) ....................... 46

Citalopram Tablets (USP erratum) .................. 864

Cladribine (USP) ............................ 49

Climbazole (USP) ........................... 891

Clonidine Transdermal System (USP erratum) ........... 863

Clopidogrel Tablets (USP) ...................... 50

Clorazepate Dipotassium Tablets (USP erratum) .......... 382

Clozapine (USP) ............................ 893

Black Cohosh (USP) ......................... 954

Black Cohosh Fluidextract (USP) .................. 958

Powdered Black Cohosh (USP) ................... 959

Powdered Black Cohosh Extract (USP) ............... 960

Black Cohosh Tablets (USP) ..................... 961

Colchicine (USP) ........................... 396

Colestipol Hydrochloride (USP) ................... 895

Colestipol Hydrochloride for Oral Suspension (USP) ....... 896

Colestipol Hydrochloride Tablets (USP) .............. 896

Corn Syrup (NF) ............................ 1240

Cupric Sulfate (USP) ......................... 898

Curcuminoids (USP) ......................... 1215

Curcuminoids Capsules (USP) .................... 1217

Curcuminoids Tablets (USP) ..................... 1218

Cyromazine (USP) ........................... 644

Cytarabine for Injection (USP) .................... 51

Dantrolene Sodium Capsules (USP) ................. 645

Dantrolene Sodium for Injection (USP erratum) .......... 631

DehydroaceticAcid (NF) ....................... 703

Desmopressin Acetate Injection (USP Erratum) .......... 631

Diclofenac Sodium Extended-Release Tablets (USP) ....... 218

Didanosine Tablets for Oral Suspension (USP) .......... 903

Diethylstilbestrol Diphosphate (USP) ................ 1165

Diethylstilbestrol Diphosphate Injection (USP) .......... 1167

Dihydrocodeine Bitartate (USP) ................... 396

Diltiazem Hydrochloride (USP) ................... 907

Diltiazem Hydrochloride Extended-Release Capsules (USP) ... 184

Dimenhydrinate (USP) ........................ 907

Dimenhydrinate Injection (USP) ................... 907

Dimethyl Sulfoxide Gel (USP) .................... 52

Dinoprost Tromethamine Injection (USP) ............. 908

Doxazosin Tablets (USP erratum) .................. 864

Doxepin Hydrochloride (USP erratum) ............... 1154

Dronabinol Capsules (USP erratum) ................. 631

Dyclonine Hydrochloride (USP) ................... 1167

Egg Phospholipids (NF) ....................... 703

Enalapril Maleate and Hydrochlorothiazide Tablets (USP) .... 220

Enoxaparin Sodium (USP) ...................... 52

Enoxaparin Sodium Injection (USP) ................. 58

Eprinomectin (USP) .......................... 60

Erythorbic Acid (NF) ......................... 1246

Esomeprazole Magenesium (USP) .................. 397

Estradiol (USP) ............................ 1167

Estradiol and Norethindrone Acetate Tablets (USP) ........ 220

Estradiol Benzoate (USP) ....................... 229

Estradiol Transdermal System (USP) ................ 225

Conjugated Estrogens Tablets (USP) ................ 35

Ethionamide (USP) .......................... 648

Ethyl Acrylate and Methyl Methacrylate Copolymer Dispersion

(NF)

.................................. 1247

Etidronate Disodium (USP) ......................648, 1146

Eucatropine Hydrochloride (USP) .................. 1168

Eucatropine Hydrochloride Ophthalmic Solution (USP) ..... 1168

FamotidineTablets (USP) ....................... 649

Fenoﬁbrate Capsules (USP) ..................... 1169

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Extended-Release Tablets (USP erratum)

............. 1155

Fexofenadine Hydrochloride Capsules (USP) ........... 1147

Fexofenadine Hydrochloride Tablets (USP) ............ 1147

Fish Oil Containing Omega-3 Acids (USP) ............ 471

Fish Oil Containing Omega-3 Acids Capsules (USP) ....... 477

Flavoxate Hydrochloride (USP) ................... 1172

Flavoxate Hydrochloride Tablets (USP) ............... 1174

Fluconazole (USP) ........................... 400

Fludarabine Phosphate Injection (USP) ............... 232

Flumazenil Injection (USP) ...................... 234

Fludeoxyglucose F 18 Injection (USP) ............... 1176

Fluvastatin Sodium (USP) ...................... 64

Fluvastatin Sodium (USP erratum) ................. 631

Formaldehyde Solution (USP) .................... 650

Formoterol Fumarate (USP) ..................... 402

Fosinopril Sodium Tablets (USP) .................. 405

Fosinopril Sodium and Hydrochlorothiazide Tablets (USP) ... 66

Fulvestrant (USP) ........................... 909

Galantamine Hydrobomide (USP) .................. 234

Galantamine Tablets (USP) ...................... 407

Gamma Cyclodextrin (NF) ...................... 707

Pharmacopeial Forum

1330

INDEX Vol. 33(6) [Nov.–Dec. 2007]

Index

Ginger (USP) .............................. 478

Ginkgo (USP erratum) ........................ 37

Glimepiride Tablets (USP) ...................... 411

Glucosamine Hydrochloride (USP) ................. 691

Glucosamine Sulfate Potassium Chloride (USP) .......... 692

Glucosamine Sulfate Sodium Chloride (USP) ........... 692

Liquid Glucose (NF) ......................... 1248

Glyburide Tablets (USP) ....................... 651

Glyceryl Monooleate (NF) ...................... 1249

Granisetron Hydrochloride (USP) .................. 1176

Powdered Decaffeinated Green Tea Extract (USP) ........693, 1220

Heparin Sodium (USP) ........................ 238

Hydrocodone Bitartrate and Homatropine Methylbromide Tablets

(USP)

................................. 654

Hydrocortisone Tablets (USP) .................... 72

Hydrogenated Polydecene (NF) ................... 485

Hydrogenated Starch Hydrolysate (NF) ............... 488

Hyoscyamine Sulfate (USP) ..................... 659

Hyoscyamine Sulfate (USP Erratum) ................ 382

Indomethacin for Injection (USP) .................. 861

Inositol (NF) .............................. 711

Human Insulin Isophane Suspension and Human Insulin Injection

(USP)

................................. 861

Iopamidol (USP) ............................ 1179

Iopamidol Injection (USP) ...................... 1182

Ipratropium Bromide (USP) ..................... 241

Isopropyl Alcohol (USP) ....................... 1182

Isosorbide Mononitrate Extended-Release Tablets (USP) ..... 659

Isosorbide Dinitrate Extended-Release Tablets (USP) ....... 73, 373

Isosorbide Mononitrate Tablets (USP) ................ 413

Isotretinoin Capsules (USP) ..................... 666

Ivermectin (USP) ........................... 912

Ivermectin Injection (USP) ...................... 913

Ivermectin Paste (USP) ........................ 914

Ivermectin Topical Solution (USP) ................. 916

Ivermectin Tablets (USP) ....................... 918

Ivermectin and Clorsulon Injection (USP) ............. 921

Lecithin (NF) .............................. 1249

Letrozole Tablets (USP) ........................ 244

Levalbuterol Hydrochloride (USP) ................. 75, 416

Levalbuterol Inhalation Solution (USP) ............... 79, 420

Levothyroxine Sodium (USP) .................... 422

Liothyronine Sodium (USP) ..................... 426

Lisinopril and Hydrochlorothiazide Tablets (USP) ......... 1182

Lorazepam (USP) ........................... 427

Lorazepam Tablets (USP) ....................... 429

Lutein (USP) .............................. 255

Lutein Preparation (USP) ....................... 255

Magaldrate and Simethicone Oral Suspension (USP) ....... 923

Magaldrate and Simethicone Tablets (USP) ............ 923

Magaldrate and Simethicone Chewable Tablets (USP) ...... 924

Magnesium Chloride (USP) ..................... 37

Meclizine Hydrochloride (USP) ...................244, 1186

Meclizine Hydrochloride Tablets (USP) ..............245, 1186

Meﬂoquine Hydrochloride (USP) .................. 667

Metformin Hydrochloride Tablets (USP) .............. 187

Methacrylic Acid Copolymer (NF) ................. 1251

Methacrylic Acid Copolymer Dispersion (NF) ........... 1254

Methdilazine Hydrochloride Oral Solution (USP erratum) .... 37

Methylphenidate Hydrochloride Tablets (USP) .......... 246

Methylphenidate Hydrochloride Extended-Release Tablets (USP) 667, 1148

Methylprednisolone (USP) ...................... 1189

Mineral Oil (USP) ........................... 962

Mineral Oil, Rectal (USP) ...................... 964

Light Mineral Oil (NF) ........................ 972

Topical Light Mineral Oil (USP) ................... 964

Mirtazapine (USP) ...........................431, 861

Mirtazapine Orally Disintegrating Tablets (USP) ......... 1189

Modiﬁed Starch (USP erratum) ................... 863

Mycophenolate Mofetil (USP) .................... 924

Naphazoline Hydrochloride Ophthalmic Solution (USP) ..... 926

Naproxen Delayed-Release Tablets (USP) ............. 1192

Nicotine Transdermal System (USP) ................ 927

Nitrofurantoin Capsules (USP) ....................669, 1149

Norethindrone Acetate and Ethinyl Estradiol Tablets (USP) ... 81, 432

Norethindrone Tablets (USP) .....................432, 1193

Norethindrone and Ethinyl Estradiol Tablets (USP) ........ 1194

Norgestimate and Ethinyl Estradiol Tablets ............. 1154

Octinoxate (USP) ........................... 246

Octocrylene (USP) ........................... 929

Oﬂoxacin Tablets (USP) ....................... 434

Omeprazole Magnesium (USP) ................... 436

Ondansetron Orally Disintegrating Tablets (USP) ......... 439

Oxandrolone (USP) .......................... 247

Oxandrolone Tablets (USP) ......................440, 625, 929

Oxybutynin Chloride (USP) ..................... 932

Oxybutynin Chloride Extended-Release Tablets (USP) ......671, 1150

Oxymetazoline Hydrochloride Nasal Solution (USP) ....... 932

Paclitaxel (USP) ............................ 250

Pamidronate Disodium for Injection (USP) ............. 81, 374

Pantoprazole Sodium (USP) ..................... 1194

Pantoprazole Sodium Delayed-Release Tablets (USP) ...... 1197

Parafﬁn (NF) .............................. 972

Paricalcitol (USP) ........................... 252

Paroxetine Tablets (USP) ....................... 672

Paroxetine Hydrochloride (USP) ................... 932

Pentazocine Hydrochloride and Acetaminophen Tablets (USP) . 1200

Phenylbutazone Boluses (USP) ................... 82

Phenylbutazone Tablets (USP) .................... 82

Piperazine Adipate (USP) ....................... 1201

Piperazine Dihydrochloride (USP) .................. 1202

Piperazine Phosphate (USP) ..................... 1204

Poloxamer (NF) ............................ 714

Polyethylene Glycol 3350 and Electrolytes for Oral Solution

(USP)

................................. 1205

Polysorbate 80 ............................. 1075

Polyvinyl Alcohol (USP) ....................... 1206

Potassium Bromide Oral Solution, Veterinary (USP) ....... 936

Povidone-Iodine (USP) ........................ 937

Powdered Bilberry Extract (USP) .................. 685

Powdered Green Tea Extract (USP) .................693, 1220

Powdered Ginger (USP) ....................... 479

Pregelatinized Modiﬁed Starch (USP erratum) ........... 863

Primaquine Phosphate (USP) ..................... 937

Primaquine Phosphate Tablets (USP) ................ 938

Progesterone Vaginal Suppositories (USP) ............. 82

Propofol Injectable Emulsion (USP) ................. 1208

Propylene Glycol (USP) ....................... 317

Propylene Glycol Dicaprylate/Dicaprate (NF) ........... 974

Propylene Glycol Monocaprylate (NF) ............... 261

Protein A (USP) ............................ 442

rProtein A (USP) ........................... 446

rProtein A, B4, C-Cys (USP) ..................... 452

rProtein A, C-Cys (USP) ....................... 444

Pullulan (NF) .............................. 975

Pygeum Extract (USP erratum) ................... 37

Pyrimethamine (USP) ......................... 939

Raloxifene Hydrochloride (USP) .................. 673

Raloxifene Hydrochloride Tablets (USP) .............. 676

Ramipril (USP erratum) ........................ 37

Ranitidine Injection (USP erratum) ................. 382

Ranitidine in Sodium Chloride Injection (USP erratum) ..... 383

Ranitidine Oral Solution (USP erratum) .............. 382

Ranitidine Tablets (USP erratum) .................. 383

Reserpine Tablets (USP) ....................... 453

Ritonavir (USP) ............................ 679

Salicylic Acid (USP) ......................... 83

Salsalate Tablets (USP) ........................ 1211

Saquinavir Mesylate (USP) ...................... 940

Sevoﬂurane (USP) ........................... 940

Hydrophobic Colloidal Silica (NF) ................. 976

Simethicone Capsules (USP) ..................... 948

Simethicone Oral Suspension (USP) ................ 948

Simethicone Tablets (USP) ...................... 948

Simvastatin (USP) ........................... 948

Sodium Bromide Injection, Veterinary (USP) ........... 949

Sodium Bromide Oral Solution, Veterinary (USP) ......... 950

Sodium Caprylate (NF) ........................ 493

Sodium Fluoride and Acidulated Phosphate Topical Solution

(USP)

.................................454, 861

Sodium Fluoride and Phosphoric Acid Gel (USP) .........455, 862

Powdered Soy Isoﬂavones Extract (USP) .............. 1224

Pharmacopeial Forum

Vol. 33(6) [Nov.–Dec. 2007]

INDEX 1331

Index

Soy Isoﬂavones Capsules (USP) ................... 1227

Soy Isoﬂavones Tablets (USP) .................... 1228

Stannous Chloride (NF) ........................ 978

Sterile Water for Inhalation (USP erratum) ............. 1154

Sucralfate (USP) ............................ 254

Sucralose (NF) ............................. 1255

Silver Sulfadiazine (USP) ....................... 951

Sulfadimethoxine Sodium (USP) .................. 254

Sulfamethoxazole (USP) ....................... 455

Sulisobenzone (USP) ......................... 456

Sumatriptan Succinate (USP) ..................... 456

Tamsulosin Hydrochloride (USP) .................. 1211

Terbinaﬁne Hydrochloride (USP) .................. 459

Tizanidine Tablets (USP) .......................680, 1151

Topiramate (USP) ........................... 461

Torsemide (USP) ............................ 1213

Trehalose (NF) ............................. 263

Triclosan (USP) ............................ 681

Tryptophan (USP) ........................... 1214

Turmeric (USP) ............................ 1229

Powdered Turmeric (USP) ...................... 1232

Powdered Turmeric Extract (USP) .................. 1232

Tylosin Injection (USP) ........................ 952

Ubidecarenone Capsules (USP) ................... 93, 374

Ubidecarenone Tablets (USP) .................... 94, 374

Valganciclovir Hydrochloride (USP) ................ 84

Valganciclovir Tablets (USP) ..................... 89

Valsartan (USP) ............................ 467

Vecuronium Bromide (USP) ..................... 682

Verapamil Hydrochloride Extended-Release Tablets (USP) ....683, 1152

Verapamil Hydrochloride (USP) ................... 953

Warfarin Sodium (USP) ........................ 468

Warfarin Sodium for Injection (USP) ................ 469

Warfarin Sodium Tablets (USP) ................... 470

EXCIPIENTS

Excipients, USP and NF Excipients, Listed by

Category (NF)

............................257, 480, 698, 966, 1234

GENERAL CHAPTERS

Acetic Acid in Peptides h503i (USP) ................ 268

Aerosols, Metered-Dose Inhalers, and Dry Powder Inhalers h601i

(USP)

................................. 550

Analytical Data—Interpretation and Treatment h1010i (USP) .. 726

Bacterial Endotoxins Test h85i (USP) ................ 539

Bulk Pharmaceutical Excipients-Certiﬁcate of Analysis h1080i

(USP)

................................. 382

Containers—Glass h660i (USP erratum) .............. 1154

Containers—Performance Testing h671i (USP erratum) ..... 1154

Dissolution h711i (USP) ....................... 626

Identiﬁcation Tests—General h191i (USP) ............. 719

Injections h1i (USP) ..........................188, 494

Intrinsic Dissolution h1087i (USP) ................. 269

Manufacturing Practices for Dietary Supplements h2750i .... 1035

Melting Range or Temperature h741i ................ 982

Microbiological Examination of Nonsterile Products: Acceptance

Criteria for Pharmaceutical Preparations and Substances for

Pharmaceutical Use h1111i (USP)

................. 207

Microbiological Examination of Nonsterile Products: Microbial

Enumeration Tests h61i (USP)

................... 189

Microbiological Examination of Nonsterile Products: Tests for

Speciﬁed Microorganisms h62i (USP)

.............. 193

Near-Infrared Spectrophotometry h1119i (USP) .......... 737

Nucleic Acid-Based Techniques Ampliﬁcation h1127i ..... 1005

Nucleic Acid-Based Techniques Approaches for Detecting Trace

Nucleic Acids (Residual DNA Testing) h1130i

......... 1025

Nucleic Acid-Based Techniques Extraction, Detection, and

Sequencing h1126i

......................... 990

Nucleic Acid-Based Techniques General h1125i ........ 984

Nucleic Acid-Based Techniques Genotyping h1129i ...... 1019

Organic Volatile Impurities h467i (USP) .............. 375

Particulate Matter in Injections h788i (USP) ............ 198

Particulate Matter in Injections h788i (USP erratum) ....... 1155

Pharmacopeial Harmonization h1196i (USP) ............ 751

Readily Carbonizable Substances Test h271i (USP) ........ 1258

Residual Solvents h467i (USP) ................... 378

Residual Solvents h467i (USP erratum) ............... 382

Sulfur Dioxide h525i (USP) ..................... 498

Supplemental Information for Articles of Botanical Origin h2030i 1029

Total Organic Carbon h643i (USP) ................. 720

USP Reference Standards h11i (USP) ................95, 267, 497, 716, 981, 1256

USP Reference Standards h11i (USP erratum) ........... 631

Validation of Compendial Methods h1225i (USP) ......... 96

Water Conductivity h645i (USP) ................... 722

Weighing on an Analytical Balance h1251i (USP) ........ 756

Weights and Balances h41i (USP) .................. 716

REAGENTS, INDICATORS, AND SOLUTIONS

Chromatographic Reagents (USP) .................104, 276, 1261

Reagent Speciﬁcations

1-Butanesulfonic Acid Sodium Salt (USP)

........... 766

Reagent Speciﬁcations Introduction ............... 503

Acetic Acid (USP) ......................... 1259

Activated Charcoal (USP) ..................... 1259

2-Aminoheptane (USP) ...................... 100

Butyrophenone (USP) ....................... 766

Calconcarboxylic Acid (USP) ................... 100

Calconcarboxylic Acid Triturate (USP) ............. 100

Cetyltrimethylammonium Bromide (USP) ............ 766

alpha-Cyclodextrin (USP) ..................... 276

Diethylamine Phosphate (USP) .................. 766

Diethylene Glycol (USP) ..................... 1259

Dimethicone, Viscosity 500 Centistokes (USP) ......... 100

4,4’-Dipyridyl ............................ 1047

Docusate Sodium (USP) ...................... 504

Ferrous Sulfate (USP) ....................... 1260

Fuchsin, Basic (USP) ....................... 766

Hexadecyltrimethylammonium Bromide (USP) ......... 767

Hexylamine (USP) ......................... 1260

Lactose (USP) ........................... 100

2-Methylpentane .......................... 1047

Naphthalene (USP) ......................... 1260

N-Heptane, Chromatographic (USP) ............... 767

Octanesulfonic Acid Sodium Salt (USP) ............ 767

4-(p-Nitrobenzyl)pyridine (USP) ................. 1260

Phloxine (USP) ........................... 1260

Potassium Pyroantimonate (USP) ................. 767

Propylamine Hydrochloride (USP) ................ 101

Pullulanase ............................. 1047

Salicylaldehyde (USP) ....................... 1260

Selenium (USP) ........................... 767

Sodium Phosphate, Monobasic, Anhydrous (USP) ....... 276

Sodium Phosphate, Monobasic, Dihydrate (USP) ....... 276

Sodium Phosphate, Dibasic, Dihydrate (USP) ......... 101

Tetrabutylammonium Iodide (USP) ............... 504

Tetrahydro-2-furancarboxylic acid (USP) ............ 1261

Tetrapropylammonium Chloride (USP) ............. 276

Triethylamine (USP) ........................101, 768

Triethylamine Phosphate (USP) .................. 1261

Test Solutions

Acetic Acid, Strong, TS (USP)

.................. 768

Alkaline Cupric Citrate TS 2 (USP) ............... 769

Ammonium Pyrrolidinedithiocarbamate, Saturated, TS (USP) 769

Cupric Citrate TS 2, Alkaline (USP) ............... 769

Sodium Hydroxide TS 2 (USP) .................. 769

Volumetric Solutions

Bismuth Nitrate, 0.01 mol/L (USP)

...............101, 769

Ceric Sulfate, Tenth-Normal (0.1 N) (USP) ...........101, 769

Lithium Methoxide, Tenth-Normal (0.1 N) in Chlorobenzene

(USP)

...............................102, 770

Lithium Methoxide, Tenth-Normal (0.1 N) in Methanol (USP) 102, 770

Lithium Methoxide, Tenth-Normal (0.1 N) in Toluene (USP) 102, 770

Magnesium Chloride, 0.01M (USP) ...............102, 770

Mercuric Nitrate, Tenth-Molar (0.1 M) (USP) .........102, 771

Potassium Hydroxide, Normal (1 N) (USP) ...........102, 771

Potassium Permanganate, Tenth-Normal (0.1 N) (USP) ....102, 771

Sodium Hydroxide, Normal (1 N) (USP) ............102, 771

Sodium Tetraphenylboron, Fiftieth-Molar (0.02 M) (USP) .. 772

Sodium Thiosulfate, Tenth-Normal (0.1 N) (USP) ....... 772

Pharmacopeial Forum

1332

INDEX Vol. 33(6) [Nov.–Dec. 2007]

Index

REFERENCE TABLES

Container Speciﬁcations (USP) ...................283, 505, 773, 1052, 1268

Description and Solubility (USP) ..................110, 285, 507, 775, 1053, 1270

GENERAL SUBJECTS

2007 USP Dictionary Now Available ................170, 358, 610, 1133

Canceled Revision Proposals .....................137, 313, 534, 802, 1071, 1290

Catalog to Be Removed from Pharmacopeial Forum Print

Publication

.............................. 19, 350

Eric B. Sheinin, Ph.D. Retires from USP .............. 358

Errata List for USP30–NF25

Bulk Pharmaceutical Excipients-Certiﬁcate of Analysis h1080i

382

Calcium Silicate (USP) ...................... 863

Citalopram Hydrobromide (USP) ................. 1155

Citalopram Tablets (USP) ..................... 864

Clonidine Transdermal System (USP) .............. 863

Clorazepate Dipotassium Tablets ................. 382

Containers—Glass h660i ..................... 1154

Containers—Performance Testing h671i ............. 1154

Dantrolene Sodium for Injection ................. 631

Desmopressin Acetate Injection ................. 631

Doxazosin Tablets (USP) ..................... 864

Doxepin Hydrochloride (USP) .................. 1154

Dronabinol Capsules ........................ 631

Fexofenadine Hydrochloride and Pseudoephedrine

Hydrochloride Extended-Release Tablets (USP)

....... 1155

Fluvastatin Sodium ......................... 631

Ginkgo ................................ 37

Hyoscyamine Sulfate ........................ 382

Magnesium Chloride ........................ 37

Methdilazine Hydrochloride Oral Solution ........... 37

Norgestimate and Ethinyl Estradiol Tablets (USP) ....... 1154

Particulate Matter in Injections h788i .............. 1155

Pygeum Extract ........................... 37

Ramipril ............................... 37

Ranitidine Injection ........................ 382

Ranitidine in Sodium Chloride Injection ............. 383

Ranitidine Oral Soltion ...................... 382

Ranitidine Tablets ......................... 383

Residual Solvents h467i ..................... 382

Modiﬁed Starch (USP) ....................... 863

Pregelatinized Modiﬁed Starch (USP) .............. 863

USP Reference Standards h11i .................. 631

Sterile Water for Inhalation (USP) ................ 1154

Erratum to h788i Particulate Matter in Injections and the USP

Particle Count Reference Standard

................ 842

Expert Committee Designations ...................12, 162, 352, 603, 835, 1123

Extractable Volume, USP–NF General Chapter h1i, Injections:

Notice of Harmonized Text

.................... 168

Fexofenadine Hydrochloride Capsules and Tablets Dissolution

Direct IRA

.............................. 1130

Fifth Interim Revision Announcement ............... 853

First Interim Revision ......................... 31, 861

Fourth Interim Revision Announcement .............. 621

Harmonization .............................139, 315, 535, 803, 1073, 1293

Harmonized Microbiology General Chapters: Notice of

Postponement

............................ 168

How to Submit Comments ......................20, 170, 360

How to Use PF .............................9, 159, 349, 599, 831, 1119

Human Insulin Isophane Suspension and Human Insulin Injection 842

Immediate IRA Commentary: Immediate Interim Revision

Announcement for USP-NF General Chapter h711i Dissolution

610

Immediate IRA Commentary: Immediate Interim Revision

Announcements for Ubidecarenone Capsules and Ubidecarenone

Tablets

................................ 358

Immediate IRA Commentary: Immediate IRA Commentary USP

Issues Immediate Interim Revision Announcement for General

Chapter h467i Residual Solvents

................. 358

Implementation Period for Upcoming Ofﬁcial Revisions to the

USP–NF Extended

......................... 19

In Memoriam .............................. 18

Interim Revision Announcements .................31, 861, 1141

International Correspondence .....................20, 170, 360

New Chromatographic Reagents Coming in September ..... 842

Nomenclature .............................147, 335, 584, 815, 1098, 1325

Notice of Harmonized Text: USP-NF General Chapter h788i

Particulate Matter in Injections

................... 610

Pharmacopeial Education Courses ..................19, 169, 359, 610, 843, 1131

Pharmacopeial Forum Public Review and Comment Period

Deadlines

...............................21, 170, 360, 611, 844, 1132

Pharmacopeial Harmonization ....................18, 1131

Policies and Announcements

Catalog to Be Removed from Pharmacopeial Forum Print

Publication

............................ 358

Eric B. Sheinin, Ph.D. Retires from USP ............ 358

Erratum to h788i Particulate Matter in Injections and the USP

Particle Count Reference Standard

.............. 842

Extractable Volume, USP–NF General Chapter h1i, Injections:

Notice of Harmonized Text

.................. 168

Fexofenadine Hydrochloride Capsules and Tablets Dissolution

Direct IRA

............................ 1130

Harmonized Microbiology General Chapters: Notice of

Postponement

.......................... 168

How to Submit Comments ....................20, 170, 360

Human Insulin Isophane Suspension and Human Insulin

Injection

............................. 842

Immediate IRA Commentary: Immediate Interim Revision

Announcements for Ubidecarenone Capsules and

Ubidecarenone Tablets

..................... 358

Immediate IRA Commentary: Immediate Interim Revision

Announcement for USP-NF General Chapter h711i

Dissolution

............................ 358

Immediate IRA Commentary USP Issues Immediate Interim

Revision Announcement for General Chapter h467i Residual

Solvents

.............................. 358

Implementation Period for Upcoming Ofﬁcial Revisions to the

USP–NF Extended

....................... 168

In Memoriam ............................ 168

International Correspondence ...................20, 170, 360

New Chromatographic Reagents Coming in September .... 168

Notice of Harmonized Text: USP–NF General Chapter h788i

Particulate Matter in Injections

................. 18

Pharmacopeial Education Courses ................19, 169, 359, 610, 843, 1131

Pharmacopeial Forum Public Review and Comment Period

Deadlines

.............................21, 170, 360, 611, 844, 1132

Pharmacopeial Harmonization .................. 18

Priority New Monograph Items ..................22, 171, 361, 612, 845, 1133

Residual Solvents: General Notices and General Chapter h467i

Implementation Date Delayed

.................842, 1130

Revision Bulletins .........................163, 610

Stimuli Articles Posted on USP’s Website ...........610, 1131

Stimuli Articles to be Posted on USP’s Website ........ 18

Tizanidine Tablets Dissolution Direct IRA ........... 1130

USP Announces New Ofﬁcers .................. 1130

USP Annual Scientiﬁc Meeting 2007 .............. 842

USP Catalog Available ......................842, 1130

2007 USP Dictionary Now Available .............. 842

USP Discontinues Use of ‘‘Intent to Comment’’ Form .... 842

USP Forms Stakeholder Forum to Address the Food Chemicals

Codex; First Meeting Set for February 2007

......... 18

USP Issues Postponement for Norgestimate and Ethinyl Estradiol

Tablets Monograph Effective August 1, 2007

........ 1130

USP Seeks Chair Candidate for Four Expert Comittees; Expert

Committee Members also Sought

............... 18

USP to Establish Ofﬁce and Laboratory Facility in China .. 19

USP to Verify the Quality of Pharmaceutical Ingredients

Worldwide

............................ 19

Vice President of Pharmacopeial Education Named ...... 19

Visit the USP Website at hhttp://www.usp.orgi .........19, 1132

Previews ................................141, 321, 1081, 1295

Pending Proposals ...........................111, 286, 509, 776, 1055, 1272

Priority New Monograph Items ...................22, 171, 361, 612, 845

Residual Solvents: General Notices and General Chapter h467i

Implementation Date Delayed

................... 842

Revision Bulletins ..........................168, 610

Second Interim Revision ....................... 179

Section Descriptions ..........................10, 160, 350, 600, 832, 1120

Sixth Interim Revision Announcement ............... 1141

Staff Directory .............................14, 164, 354, 605, 837, 1125

Standards Development ........................5, 155, 345, 595, 827

Pharmacopeial Forum

Vol. 33(6) [Nov.–Dec. 2007]

INDEX 1333

Index

Stimuli to the Revision Process ...................571, 1083, 1299

A New Validated Differential Calorimetric Procedure for

Monitoring the Less Active R,S Isomer of Ethambutol

Dihydrochloride in Bulk Drug Samples and Anti-tuberculosis

Formulations

........................... 326

The Application of Uncertainty to USP’s Compendial Reference

Standards Program: Certiﬁed Reference Materials, Ronald G.

Manning, Steven Lane, Shawn Dressman, Walter W. Hauck,

and Roger L. Williams

..................... 1300

Assessing Antioxidant Activity in Botanicals and Other Dietary

Supplements, Stephen Matthew Phipps, Maged H. M. Sharaf,

and Veronika Butterweck

.................... 810

Instructions to Authors .......................145, 325, 573, 809, 1085, 1299

Proposed Change to Acceptance Criteria for Dissolution

Performance Veriﬁcation Testing

............... 574

Proposed New USP General Information Chapter, Excipient

Performance, Gregory E. Amidon, Garnet E. Peck, Lawrence

H. Block, Richard C. Moreton, Ashok Katdare, Robert Lafaver,

and Catherine Sheehan

..................... 1311

Summary of Planned Revisions to Design and Analysis of

Biological Assays h111i

..................... 580

Toward A Uniform System for Naming Vaccines and Polyclonal

Immune Globulins, John D. Grabenstein

........... 1085

Stimuli Articles Posted on USP’S Website .............18, 1131

Stimuli Articles to be Posted on USP’s Website .......... 19

Third Interim Revision ........................ 369

Tizanidine Tablets Dissolution Direct IRA ............. 1130

USP Annual Scientiﬁc Meeting 2007 ................168, 358, 610

USP Announces New Ofﬁcers .................... 1130

USP Catalog Available ........................169, 358, 610, 842, 1130

2007 USP Dictionary Now Available ................170, 358, 610

USP Discontinues Use of ‘‘Intent to Comment’’ Form ...... 19

USP Forms Stakeholder Forum to Address the food chemicals

Codex; First Meeting Set for February 2007

........... 18

USP Issues Postponement for Norgestimate and Ethinyl Estradiol

Tablets Monograph Effective August 1, 2007

.......... 1130

USP Seeks Chair Candidate for Four Expert Comittees; Expert

Committee Members also Sought

................. 18

USP to Establish Ofﬁce and Laboratory Facility in China .... 168

USP to Verify the Quality of Pharmaceutical Ingredients

Worldwide

.............................. 168

Vice President of Pharmacopeial Education Named ........ 18

Visit the USP Website at hhttp://www.usp.orgi ...........20, 170, 360, 611, 844, 1132

Pharmacopeial Forum

1334

INDEX Vol. 33(6) [Nov.–Dec. 2007]

Index

[Note—This index covers Vol. 34 No. 1, pp. 1–200; Vol. 34 No.

2, pp. 201–510; Vol. 34 No. 3, pp. 511–856; Vol. 34 No. 4, pp.

857–1088; Vol. 34 No. 5, pp. 1089–1364; and Vol. 34 No. 6,

pp. 1365–1656.]

GENERAL NOTICES AND REQUIREMENTS

General Notices and Requirements—NF .............. 119

General Notices and Requirements—USP ............. 40

Tests and Assays (USP erratum) ................... 36

USP General Notices and Requirements (Erratum) ........ 554

MONOGRAPHS

Acetaminophen (USP) ........................ 1136

Acetaminophen and Codeine Phosphate Oral Suspension (USP

erratum)

................................ 1131

Acetone (NF) .............................. 120

Albendazole (USP) .......................... 69

rAlbumin Human (NF) ........................ 121

Albuterol Sulfate (USP) ........................ 242

Alendronate Sodium Tablets (USP) ................. 35, 545

Alfadex (NF) .............................. 126

Alfuzosin Hydrochloride (USP) ................... 69

Allopurinol (USP) ........................... 70

Aluminum Acetate Topical Solution (USP) ............. 242

Aluminum Subacetate Topical Solution USP) ........... 242

Amifostine (USP) ........................... 1136

Amino Methacrylate Copolymer (NF) ............... 326

Aminophylline (USP) ......................... 72

Amiodarone Hydrochloride (USP) .................. 1429

Amitriptyline Hydrochloride (USP erratum) ............ 895

Amlodipine Besylate (USP) ..................... 1136

Amlodipine Besylate Tablets (USP) ................. 1137

Ammonium Sulfate (NF Erratum) .................. 238

Amodiaquine Hydrochloride (USP) ................. 243

Amodiaquine Hydrochloride Tablets (USP) ............ 558

Amphetamine Sulfate (USP) ..................... 902

Amphetamine Sulfate Tablets (USP) ................ 904

Ampicillin (USP) ........................... 1140

Anastrozole (USP) ........................... 244

Aspirin (USP) ............................. 1143

Aspirin and Codeine Phosphate Tablets (USP erratum) ...... 895

Atovaquone (USP) ........................... 247

Atovaquone Oral Suspension (USP) ................. 247

Atracurium Besylate Injection (USP) ................ 905

Aurothioglucose Injectable Suspension (USP) ........... 906

Azithromycin (USP) .......................... 559

Azithromycin for Injection (USP) .................. 562

Azithromycin Tablets (USP) ..................... 1143

Aztreonam for Injection (USP) .................... 906

Behenoyl Polyoxylglycerides (NF) ................. 1217

Belladonna Extract (USP erratum) .................. 895

Benzalkonium Chloride (NF) ..................... 1012

Benzocaine (USP) ........................... 1147

Benzoic Acid (USP) .......................... 1147

Betadex (NF) .............................. 127

Betamethasone Sodium Phosphate and Betamethasone Acetate

Injectable Suspension (USP Erratum)

............... 238

Betamethasone Oral Solution (USP) ................. 567

Bicalutamide Tablets (USP) .....................73, 1147

Bisoprolol Fumarate Tablets (USP) ................. 570

Black Cohosh (USP) ......................... 236

Black Cohosh Fluidextract (USP) .................. 236

Powdered Black Cohosh (USP) ................... 237

Powdered Black Cohosh Extract (USP) ............... 237

Black Cohosh Tablets (USP) ..................... 237

Bleomycin for Injection (USP) .................... 1150

Bovine Acellular Dermal Matrix (USP erratum) .......... 1425

Budesonide (USP) ........................... 907

Bupivacaine Hydrochloride (USP) .................. 75

Bupropion Hydrochloride Extended-Release Tablets (USP) ...570, 1123

Butylated Hydroxytoluene (NF) ................... 130

Butylparaben (NF) ........................... 1592

Cabergoline (USP) ........................... 75

Cabergoline Tablets (USP) ...................... 572

Caffeine (USP) ............................. 1150

Calcitonin Salmon (USP erratum) ..................238, 895, 1425

Calcium Carbonate Lozenges (USP erratum) ............ 895

Calcium Citrate Tablets (USP) .................... 312

Calcium Gluceptate (USP erratum) ................. 36

Calcium Propionate (NF) ....................... 1517

Calcium and Vitamin D with Minerals Tablets (USP) ....... 1491

Caprylocaproyl Polyoxylglycerides (NF) .............. 1012

Carbidopa and Levodopa Extended-Release Tablets (USP) .... 1433

Carbomer 934 (NF) .......................... 131

Carbomer 934P (NF) ......................... 132

Carbomer 940 (NF) .......................... 133

Carbomer 941 (NF) .......................... 133

Carbomer Copolymer (NF) ...................... 134

Carbomer Homopolymer (NF) .................... 136

Carbomer Interpolymer (NF) ..................... 138

Enzymatically-Hydrolyzed Carboxymethylcellulose Sodium (NF) 1519

Carvedilol (USP) ............................574, 1124, 1399

Carvedilol Tablets (USP) .......................579, 1126

Cefaclor Capsules (USP) ....................... 248

Cefazolin Sodium (USP) ....................... 1438

Cefdinir Capsules (USP) ....................... 77

Cefdinir for Oral Suspension (USP) ................. 81

Ceﬁxime for Oral Suspension (USP) ................ 1441

Cefotetan Disodium (USP) ...................... 86, 545

Cefotetan for Injection (USP) .................... 86, 545

Cefoxitin Sodium (USP erratum) .................. 895

Cefpodoxime Proxetil (USP erratum) ................ 1424

Ceftazidime Injection (USP) ..................... 907

Ceftiofur Hydrochloride (USP) .................... 908

Ceftiofur Sodium (USP) ....................... 912

Siliciﬁed Microcrystalline Cellulose (NF) ............. 1218

Cetylpyridinium Chloride Topical Solution (USP erratum) .... 1131

Cherry Syrup (NF erratum) ...................... 36

Chloral Hydrate (USP) ........................ 1150

Chloramphenicol Oral Solution (USP erratum) ..........896, 1424

Chlordiazepoxide Hydrochloride Capsules (USP erratum) .... 896

Chlorhexidine Acetate (USP) ..................... 582

Chlorhexidine Gluconate Oral Rinse (USP) ............ 250

Chlorhexidine Gluconate Solution (USP) .............. 250

Chlorhexidine Hydrochloride (USP) ................. 585

Chloroquine (USP) .......................... 86

Chloroquine Phosphate (USP) .................... 251

Chloroquine Phosphate Tablets (USP) ............... 587

Cilostazol (USP) ............................ 589

Cisapride (USP) ............................ 253

Citalopram Hydrobromide (USP) .................. 917

Citalopram Hydrobromide (USP erratum) ............. 554

Anhydrous Citric Acid (USP) .................... 1150

Citric Acid Monohydrate (USP) ................... 1151

Clavulanate Potassium (USP) .................... 1441

Clindamycin Palmitate Hydrochloride (USP) ............ 1442

Clioquinol Cream (USP erratum) .................. 896

Clonazepam Orally Disintegrating Tablets (USP) ......... 254

Cloprostenol Injection (USP) ..................... 918

Cloprostenol Sodium (USP) ..................... 920

Clozapine Tablets (USP) ....................... 589

Cocaine (USP) ............................. 1151

Cocaine Hydrochloride (USP) .................... 1151

Hydrogenated Coconut Oil (NF) ................... 327

Codeine (USP) ............................. 1151

Codeine Sulfate (USP) ........................ 1151

Corn Oil (NF) ............................. 1220

High Fructose Corn Syrup (NF) ................... 329

Cottonseed Oil (NF) .......................... 1222

Cromolyn Sodium Inhalation Powder (USP erratum) ....... 554

Dactinomycin (USP) .........................589, 1127

Dantrolene Sodium Capsules (USP) ................. 1151

Desoxycholic Acid (NF) ....................... 1523

Dextroamphetamine Sulfate (USP) ................. 921

Dextrose (USP) ............................ 1585

Diclofenac Potassium (USP) ..................... 87

Diclofenac Potassium (USP Erratum) ................ 238

Diclofenac Potassium Tablets (USP) ................257, 891

Diclofenac Sodium Delayed-Release Tablets (USP erratum) ... 1424

Dicyclomine Hydrochloride (USP) ................. 1152

Dicyclomine Hydrochloride Capsules (USP erratum) ....... 554

Pharmacopeial Forum

1652

INDEX Vol. 34(6) [Nov.–Dec. 2008]

Index

Didanosine (USP) ........................... 87

Didanosine for Oral Solution (USP) ................. 1443

Dimethyl Sulfoxide (USP) ...................... 88

Dipivefrin Hydrochloride (USP) ................... 89

Disopyramide Phosphate (USP) ................... 90

Dopamine Hydrochloride (USP) ................... 1152

Doxazosin Mesylate (USP) ...................... 1152

Doxycycline Hyclate Delayed-Release Tablets (USP) ....... 589

Dronabinol (USP) ........................... 90

Ecamsule Solution (USP) ....................... 1153

Enalaprilat Injection (USP) ...................... 593

Endotoxin Indicator for Depyrogenation (USP) .......... 1444

Enroﬂoxacin (USP) .......................... 924

Epinephrine (USP) ........................... 91

Sterile Erythromycin Ethylsuccinate (USP) ............. 1158

Erythromycin Pledgets (USP) .................... 1157

Estradiol and Norethindrone Acetate Tablets (USP) ........928, 1401

Estradiol Tablets (USP) ........................ 596

Estradiol Vaginal Inserts (USP) ................... 597

Ethyl Acetate (NF) .......................... 1223

Ethyl Maltol (NF) ........................... 1224

Ethylparaben (NF) ........................... 1594

Famotidine for Oral Suspension (USP) ............... 1158

Fenoﬁbrate Capsules (USP) ..................... 91, 258

Fenoprofen Calcium (USP) ...................... 601

Fentanyl (USP) ............................. 602

Fexofenadine Hydrochloride (USP) .................606, 1127

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Extended-Release Tablets (USP)

..................95, 262, 546, 892, 1158, 1445

Fexofenadine Hydrochloride Tablets (USP) ............ 931

Fish Oil Containing Omega-3 Acids (USP) ............ 1207

Flavoxate Hydrochloride Tablets (USP) ............... 607

Fluconazole (USP) ........................... 96

Fluconazole Injection (USP) ..................... 266

Fluconazole Tablets (USP) ...................... 932

Fludarabine Phosphate for Injection (USP) ............. 933

Fludeoxyglucose F 18 Injection (USP) ............... 894

Fluticasone Propionate Cream (USP) ................ 609

Fluticasone Propionate Ointment (USP) .............. 611

Fluvoxamine Maleate Tablets (USP Erratum) ........... 238

Foscarnet Sodium (USP) ....................... 97

Fosinopril Sodium (USP) ....................... 613

Fosphenytoin Sodium (USP) ..................... 270

Gabapentin (USP erratum) ...................... 896

Gabapentin Capsules (USP erratum) ................ 896

Gabapentin Tablets (USP) ...................... 934

Galantamine Tablets (USP) ...................... 1452

Glipizide Tablets (USP) ........................ 1402

Glutamic Acid (USP) ......................... 997

Glyburide and Metformin Hydrochloride Tablets (USP) ..... 1163

Granisetron Hydrochloride Injection (USP) ............ 935

Granisetron Hydrochloride Oral Suspension (USP) ........ 1454

Granisetron Hydrochloride Tablets (USP) ............. 937

Grape Seeds Oligomeric Proanthocyanidins (USP) ........ 659

Ground Limestone (USP) ....................... 998

Guggul (USP) ............................. 1000

Native Guggul Extract (USP) .................... 1002

Puriﬁed Guggul Extract (USP) .................... 1003

Guggul Tablets (USP) ......................... 1004

Halazone (USP) ............................ 1163

Haloperidol Decanoate (USP) .................... 614

Hawthorn Leaf with Flower (USP) ................. 1209

Powdered Hawthorn Leaf with Flower (USP) ........... 1209

Human Insulin Isophane Suspension and Human Insulin Injection

(USP)

................................. 941

Hydroxychloroquine Sulfate Tablets (USP) ............. 940

Hydroxyethyl Cellulose (NF) ..................... 1595

Hydroxyzine Pamoate (USP) ..................... 271

Hydroxyzine Pamoate Capsules (USP) ............... 272

Hydroxyzine Pamoate Oral Suspension (USP) ........... 273

Ibuprofen (USP) ............................ 941

Ibuprofen Tablets (USP) ....................... 941

Imipramine Hydrochloride (USP) .................. 1164

Indium In 111 Chloride Solution (USP) ............... 547

Iobenguane I 131 Injection (USP Erratum) ............. 238

Irbesartan (USP) ............................ 1164

Irbesartan and Hydrochlorothiazide Tablets (USP) ........ 235

Isotretinoin Capsules (USP) .....................274, 942

Itraconazole (USP) ........................... 947

Ivermectin Tablets (USP) ....................... 948

Ivermectin and Pyrantel Pamoate Tablets (USP) .......... 277

Ketoprofen (USP) ........................... 617

Ketoprofen Extended-Release Capsules (USP) ........... 951

Alpha-Lactalbumin (NF) ....................... 670

Lactic Acid (USP) ........................... 1164

Lamotrigine (USP) .......................... 617

Lanolin Alcohols (NF) ........................ 1014

Lauroyl Macrogolglycerides (NF) .................. 1224

Lauroyl Polyoxylglycerides (NF) .................. 1224

Levonorgestrel (USP) ......................... 620

Levorphanol Tartrate (USP) ..................... 280

Levothyroxine Sodium Oral Powder (USP) ............ 954

Levothyroxine Sodium Tablets (USP) ................100, 954

Lindane (USP) ............................. 280

Linoleoyl Macrogolglycerides (NF) ................. 1015

Linoleoyl Polyoxylglycerides (NF) ................. 1015

Liothyronine Sodium Tablets (USP) ................. 955

Liotrix Tablets (USP) ......................... 955

Lipid Injectable Emulsion (USP) .................. 621

Lipid Injectable Emulsion (USP erratum) .............. 1425

Alpha Lipoic Acid (USP) ....................... 1209

Lisinopril and Hydrochlorothiazide Tablets (USP) ......... 956

Lisinopril Tablets (USP) ....................... 956

Loratadine Orally Disintegrating Tablets (USP) .......... 624

Losartan Potassium (USP) ...................... 626

Losartan Potassium Tablets (USP) .................. 1164

Losartan Potassium and Hydrochlorothiazide Tablets (USP) ... 1455

Mafenide Acetate Cream (USP) ................... 280

Mafenide Acetate for Topical Solution (USP) ........... 627

Mannitol (USP) ............................ 1588

Mannitol Injection (USP erratum) .................. 896

Meclocycline Sulfosalicylate (USP) ................. 627

Meclocycline Sulfosalicylate Cream (USP) ............. 628

Mefenamic Acid (USP) ........................ 281

Meloxicam Tablets (USP) ...................... 547

Meradimate (USP) ........................... 100

Mesna (USP) .............................. 1168

Metformin Hydrochloride Extended-Release Tablets (USP) ... 1403

Methacholine Chloride (USP) .................... 629

Methotrexate (USP) .......................... 630

Methoxsalen Capsules (USP) ..................... 101

Methyl Alcohol (NF) .........................139, 1226

Methylene Blue Injection, Veterinary (USP) ............ 1461

Methylparaben (NF) .......................... 1601

Metoprolol Succinate (USP Erratum) ................ 238

Metronidazole (USP) ......................... 631

Metronidazole Capsules (USP) .................... 633

Midazolam (USP) ........................... 961

Midazolam Injection (USP) ...................... 635

Minerals Capsules (USP) ....................... 1493

Minerals Tablets (USP) ........................ 1495

Minocycline Periodontal System (USP) ............... 963

Mirtazapine (USP) ........................... 964

Moxiﬂoxacin Hydrochloride (USP) ................. 1170

Moxiﬂoxacin Ophthalmic Solution (USP) ............. 1173

Mupirocin Calcium (USP) ...................... 101

Mupirocin Cream (USP) ....................... 281

Mupirocin Nasal Ointment (USP) .................. 966

Naltrexone Hydrochloride (USP) .................. 283

Nateglinide (USP) ........................... 1463

Niacinamide (USP) .......................... 1176

Nifedipine Extended-Release Tablets (USP) ............638, 1127

Norethindrone Acetate (USP) .................... 969

Norgestimate and Ethinyl Estradiol Tablets (USP) .........969, 1408

Nystatin Oral Suspension (USP) ...................103, 547

Octisalate (USP) ............................ 970

Oﬂoxacin Tablets (USP) ....................... 1467

Olanzapine (USP) ........................... 641

Oleoyl Macrogolglycerides (NF) ................... 1016

Oleoyl Polyoxylglycerides (NF) ................... 1016

Omega-3 Acids Triglycerides (USP) ................ 662

Ondansetron Tablets (USP) ...................... 971

Pharmacopeial Forum

Vol. 34(6) [Nov.–Dec. 2008]

INDEX 1653

Index

Ondansetron Orally Disintegrating Tablets (USP) ......... 1467

Orbiﬂoxacin (USP) .......................... 283

Orbiﬂoxacin Tablets (USP) ...................... 286

Orphenadrine Citrate Extended-Release Tablets (USP) ...... 643

Oseltamivir Phosphate (USP) .................... 1468

Oseltamivir Phosphate Capsules (USP) ............... 1471

Oxaliplatin (USP) ........................... 973

Oxaliplatin for Injection (USP) .................... 1473

Oxandrolone Tablets (USP) ...................... 235

Oxcarbazepine (USP) ......................... 1177

Oxcarbazepine Tablets (USP) .................... 1478

Oxprenolol Hydrochloride Extended-Release Tablets (USP

erratum)

................................ 1424

Oxybutynin Chloride (USP) ..................... 35

Oxycodone Hydrochloride (USP) .................. 1480

Oxytocin (USP) ............................ 647

Oxytocin (USP erratum) ....................... 1424

Palm Oil (NF) ............................. 1018

Hydrogenated Palm Oil (NF) ..................... 330

Pamidronate Disodium (USP) .................... 1179

Pantoprazole Sodium (USP) ..................... 547

Pantoprazole Sodium Delayed-Release Tablets (USP) ...... 549

Peanut Oil (NF) ............................ 1525

Pergolide Oral Suspension, Veterinary (USP) ........... 289

Permethrin Cream (USP) ....................... 103

Phenylephrine Hydrochloride (USP) ................ 291

Physostigmine (USP) ......................... 1179

Physostigmine Salicylate (USP) ................... 1179

Physostigmine Sulfate (USP) ..................... 1179

Pilocarpine Hydrochloride (USP) .................. 1179

Pilocarpine Hydrochloride Tablets (USP) .............. 291

Pilocarpine Nitrate (USP) ....................... 1179

Piperacillin and Tazobactam for Injection (USP) .......... 980

Piperazine (USP) ............................ 105

Piperazine Citrate (USP) ....................... 106

Hydrogenated Polydecene (NF) ................... 1227

Polyvinyl Acetate (NF) ........................ 1526

Polyvinyl Alcohol (USP erratum) .................. 1425

Potassium Bitartrate (USP) ...................... 1180

Potassium Citrate Tablets (USP) ................... 313

Potassium Iodide Delayed-Release Tablets (USP) ......... 1481

Pralidoxime Chloride for Injection (USP) ............. 1180

Pravastatin Sodium (USP) ...................... 294

Pravastatin Sodium Tablets (USP) .................. 1180

Prednisolone Sodium Phosphate (USP) ............... 108

Proguanil Hydrochloride (USP) ................... 296

Propoxycaine and Procaine Hydrochlorides and Norepinephrine

Bitartrate Injection (USP)

...................... 110

Propoxyphene Napsylate and Aspirin Tablets (USP erratum) .. 897

Propoxyphene Napsylate Tablets (USP Erratum) ......... 238

Propylene Glycol Monolaurate (NF) ................ 140

Propylparaben (NF) .......................... 1603

Pseudoephedrine Hydrochloride (USP) ...............110, 298

Pyrantel Pamoate (USP) ....................... 1482

Pyridoxine Hydrochloride Tablets (USP erratum) ......... 1131

Quinapril Tablets (USP) ........................ 1182

Ranitidine Hydrochloride (USP) ................... 299

Riboﬂavin Tablets (USP erratum) .................. 1131

Risedronate Sodium (USP) ...................... 1183

Risedronate Sodium Tablets (USP) ................. 1186

Rocuronium Bromide (USP) ..................... 648

Rubidium Chloride Rb 82 Injection (USP) ............. 1425

Secobarbital Sodium (USP) ...................... 984

Sertraline Hydrochloride (USP) ................... 1189

Sibutramine Hydrochloride (USP) .................. 986

Simethicone Emulsion (USP) .................... 652

Simethicone Tablets (USP) ...................... 652

Sodium Fluoride (USP) ........................ 653

Sodium Sulfate (USP) ......................... 1192

Soybean Oil (USP) .......................... 989

Spectinomycin for Injectable Suspension (USP) .......... 1193

Stavudine (USP) ............................ 653

Stearoyl Macrogolglycerides (NF) .................. 1228

Stearoyl Polyoxylglycerides (NF) .................. 1228

Sterile Puriﬁed Water (USP erratum) ................ 1425

Sterile Water for Inhalation (USP erratum) ............. 1425

Sterile Water for Irrigation (USP erratum) ............. 1425

Streptomycin Injection (USP) .................... 1193

Sulfadoxine (USP) ........................... 300

Sulfadoxine and Pyrimethamine Tablets (USP) .......... 301

Sulfasalazine (USP) .......................... 653

Sulfasalazine Tablets (USP) ..................... 653

Sulﬁnpyrazone (USP) ......................... 1483

Tamsulosin Hydrochloride Capsules (USP) ............. 1193

Tazobactam (USP) ........................... 302

Terbinaﬁne Hydrochloride (USP) .................. 1197

Terconazole (USP) ........................... 991

Thiamine Hydrochloride (USP erratum) .............. 1131

Thimerosal (USP) ........................... 1197

Thioguanine (USP) .......................... 305

Tiagabine Hydrochloride (USP) ................... 306

Tobramycin Inhalation Solution (USP) ............... 307

Topiramate Tablets (USP) ....................... 1197

Trace Elements Injection (USP erratum) .............. 1424

Tramadol Hydrochloride (USP) ................... 1200

Trandolapril (USP) .......................... 310

Tranexamic Acid (USP) ........................ 1484

Trehalose (NF) ............................. 677

Tretinoin Gel (USP) .......................... 1485

Triamterene Capsules (USP) ..................... 654

Triazolam (USP erratum) ....................... 36

Tribasic Calcium Phosphate (NF erratum) ............. 895

Tylosin Injection (USP) ........................ 1205

Valproate Sodium Injection (USP) ..................312, 894

Valproic Acid Injection (USP) ....................312, 894

Valrubicin Intravesical Solution (USP) ............... 1486

Vancomycin Hydrochloride (USP erratum) ............. 36, 897

Vancomycin Hydrochloride (USP) .................. 111

Vancomycin Hydrochloride Capsules (USP) ............ 1487

Vancomycin Hydrochloride for Injection (USP) ..........112, 992

Sterile Vancomycin Hydrochloride (USP) ............. 112

Vasopressin (USP) ........................... 994

Vasopressin Injection (USP) ..................... 995

Vinblastine Sulfate for Injection (USP) ............... 995

Oil- and Water-Soluble Vitamins with Minerals

Capsules (USP)

........................... 1498

Oil- and Water-Soluble Vitamins with Minerals Tablets (USP) . 1500

Water-Soluble Vitamins with Minerals Capsules (USP) ...... 1505

Water-Soluble Vitamins with Minerals Tablets (USP) ....... 1507

Xylose (USP) .............................. 995

Zein (NF) ................................ 1019

Zidovudine (USP) ........................... 656

Zidovudine Capsules (USP) ..................... 657

Zidovudine Injection (USP) ..................... 658

Zinc Citrate (USP) ........................... 315

Zinc Citrate Tablets (USP) ...................... 316

Zinc and Vitamin C Lozenges (USP) ................ 317

Zolpidem Tartrate (USP) ....................... 1487

Zonisamide (USP) ........................... 1489

EXCIPIENTS

Excipients, USP and NF Excipients,

Listed by Category (NF)

......................114, 320, 664, 1006, 1211, 1511

GENERAL CHAPTERS

Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder

Inhalers h601i (USP erratum)

................... 1424

Analytical Data – Interpretation and Treatment h1010i (USP) .. 764

Bovine Serum h1024i (USP) ..................... 776

Chromatography h621i (USP) ....................152, 757, 1238

Containers—Auxiliary Components h670i (USP) ......... 1533

Containers—Performance Testing h671i (USP) .......... 337

Containers—Plastics h661i (USP) .................. 335

Design and Analysis of Biological Assays h111i (USP) ..... 685

Disintegration h701i (USP) ...................... 155

Disintegration and Dissolution of Dietary Supplements h2040i

(USP)

................................. 435

Dissolution h711i (USP) ....................... 1243

Elastomeric Closures for Injections h381i (USP erratum) ..... 897

Fats and Fixed Oils h401i (USP) .................. 736

Fluorescence Spectroscopy h853i (USP) .............. 1252

Pharmacopeial Forum

1654

INDEX Vol. 34(6) [Nov.–Dec. 2008]

Index

Globule Size Distribution in Lipid Injectable Emulsions h729i

(USP)

................................. 341

Good Manufacturing Practices for Bulk Pharmaceutical Excipients

h1078i (USP)

............................. 343

Identiﬁcation Tests—General h191i (USP) ............. 333

Injections h1i (USP) .......................... 1020

Insulin Assays h121i (USP erratum) ................ 554

In Vivo Bioequivalence Guidances h1090i (USP) ......... 1028

Loss on Drying h731i (USP) ..................... 760

Microbial Examination of Nonsterile Products: Microbial

Enumeration Tests h61i (USP)

................... 1409

Microbiological Examination of Nonsterile Products: Tests for

Speciﬁed Microorganisms h62i (USP)

.............. 1413

Mid-Infrared Spectroscopy h854i (USP) .............. 1266

Newtonian Viscosity h911i (USP) .................. 1536

Nomenclature h1121i (USP) ..................... 159

Non-Newtonian Rheology h912i (USP) ............... 1541

Organic Volatile Impurities h467i (USP) ..............747, 752, 1232

Osmolality and Osmolarity h785i (USP) ..............157, 1251

Particulate Matter Determination in Parenteral and Ophthalmic

Products h1788i (USP)

....................... 421

Particulate Matter in Injections h788i (USP erratum) ....... 238

Physical Environments That Promote Safe Medication Use h1066i

(USP)

................................. 1549

Residual Solvents h467i (USP erratum) ............... 238

Residual Solvents h467i (USP) ...................747, 752, 1232

Signiﬁcant Change Guide for Bulk Pharmaceutical Excipients

h1195i (USP)

............................. 375

Sterility Tests h71i (USP) ....................... 1418

Test for 1,6-Anhydro Derivative for Enoxaparin Sodium h207i

(USP)

................................. 143

Thermal Analysis h891i (USP) .................... 1023

Total Organic Carbon h643i (USP) ................. 1241

Ultraviolet-Visible Spectroscopy h857i (USP) ........... 1282

Uniformity of Dosage Units h905i (USP) ............. 1290

USP Reference Standards h11i

(USP)

.................................142, 332, 553, 680, 1021, 1130, 1230, 1531

Vaccines for Human Use—General Considerations h1235i (USP) 1297

Validation of Compendial Procedures h1225i (USP) ....... 794

Virology Test Methods h1237i (USP) ................ 391

Water Determination h921i (USP) .................. 761

Weighing on an Analytical Balance h1251i (USP) ........ 798

Weights and Balances h41i (USP) .................. 682

REAGENTS, INDICATORS, AND SOLUTIONS

Chromatographic Reagents (USP) ..................1423, 1559

Reagent Speciﬁcations

Acetylacetone (USP)

........................ 808

Alcohol (USP) ........................... 442

Alcohol, Denatured (USP) ..................... 808

8-Amino-6-methoxyquinoline (USP) ............... 162

p-Aminophenol (USP) ....................... 442

a-Amylase (USP) .......................... 162

Barium Chloride (USP) ...................... 442

Beclomethasone (USP) ...................... 808

Bismuth Subnitrate (USP) ..................... 162

Calcium Chloride (USP) ...................... 808

Chloramine T (USP) ........................ 442

Diatomaceous Earth (USP) .................... 809

2,7-Dihydroxynaphthalene (USP) ................ 809

N,N-Dimethyldecylamine (USP) ................. 1041

Dimethyltin Dibromide (USP) .................. 442

Ethylenediamine (USP) ...................... 442

Ferric Chloride (USP) ....................... 443

Hydrogen Peroxide, 30 Percent (USP) .............. 443

Hydrogen Peroxide, 30 Percent, Unstabilized (USP) ...... 809

Hydrogen Peroxide, 50 Percent in Water (USP) ........ 809

Lead Acetate (USP) ........................ 443

Maltotriose (USP) ......................... 809

7-Methoxycoumarin (USP) .................... 443

Methylbenzothiazolone hydrazone hydrochloride (USP) ... 1319

Morin (USP) ............................ 443

Phosphatase Enzyme, Alkaline (USP) .............. 809

Silver Nitrate (USP) ........................ 810

Sodium 1-decanesulfonate (USP) ................. 1319

Sodium Cholate Hydrate (USP) ................. 810

Sodium Phosphite Pentahydrate (USP) ............. 162

Sorbitol (USP) ........................... 810

Tetrabutylammonium Hydrogen Sulfate Ion Pairing Reagent

(USP)

............................... 1041

Tetrabutylammonium Hydroxide 30-Hydrate (USP) ...... 810

Tetrabutylammonium Hydroxide, 40 Percent in Water (USP) . 810

2,3,7,8-Tetrachlorodibenzo-p-dioxin,

C-labeled (USP) .... 810

2,3,7,8-Tetrachlorodibenzofuran,

C-labeled (USP) ...... 811

Tetrahexylammonium Hydrogen Sulfate (USP) ......... 162

Triethylenediamine (USP) ..................... 443

Trimethyltin Bromide (USP) ................... 444

Test Solutions

Acetic Acid, Glacial, TS (USP)

.................. 811

Alcoholic TS (USP) ........................ 811

Ammonia TS 2 (USP) ....................... 444

Iodine and Potassium Iodide TS 3 (USP) ............ 444

Lanthanum Nitrate TS (USP) ................... 444

Methyl Red TS 2 (USP) ...................... 445

Potassium Pyroantimonate TS (USP) .............. 812

Volumetric Solutions

Bismuth Nitrate, 0.01 mol/L (USP)

...............163, 1041

Potassium Iodate, Twentieth Molar (0.05 M) .......... 813

Potassium Thiocyanate, Tenth-Normal (0.1 N) (USP) ..... 1043

Sodium Tetraphenylboron, Fiftieth-Molar (0.02 M) (USP) .. 447

REFERENCE TABLES

Container Speciﬁcations (USP) ...................165, 448, 815, 1044, 1320, 1563

Description and

Solubility (USP)

...........................166, 450, 553, 817, 1046, 1322, 1565

GENERAL SUBJECTS

Canceled Proposals ..........................180, 465, 831, 1062, 1337, 1582

Cautionary Statements Added to Black Cohosh-related

Monographs

............................. 220

Errata List for USP 31–NF 26

Acetaminophen and Codeine Phosphate Oral Suspension

(USP)

............................... 1131

Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder

Inhalers h601i (USP)

...................... 1424

Amitriptyline Hydrochloride (USP) ............... 895

Ammonium Sulfate (NF) ..................... 238

Aspirin and Codeine Phosphate Tablets (USP) ......... 895

Belladonna Extract (USP) ..................... 895

Betamethasone Sodium Phosphate and Betamethasone Acetate

Injectable Suspension (USP)

.................. 238

Bovine Acellular Dermal Matrix (USP) ............. 1425

Calcitonin Salmon (USP) .....................238, 895, 1425

Calcium Carbonate Lozenges (USP) ............... 895

Calcium Gluceptate (USP) .................... 36

Cefoxitin Sodium (USP) ...................... 895

Cefpodoxime Proxetil (USP) ................... 1424

Cetylpyridinium Chloride Topical Solution (USP) ....... 1131

Cherry Syrup (NF) ......................... 36

Chloramphenicol Oral Solution (USP) ..............896, 1424

Chlordiazepoxide Hydrochloride Capsules (USP) ....... 896

Citalopram Hydrobromide (USP) ................. 554

Clioquinol Cream (USP) ...................... 896

Cromolyn Sodium Inhalation Powder (USP) .......... 554

Diclofenac Potassium (USP) ................... 238

Diclofenac Sodium Delayed-Release Tablets (USP) ...... 1424

Dicyclomine Hydrochloride Capsules (USP) .......... 554

Elastomeric Closures for Injections h381i (USP) ........ 897

Fluvoxamine Maleate Tablets (USP) ............... 238

Gabapentin (USP) ......................... 896

Gabapentin Capsules (USP) .................... 896

General Notices and Requirements—USP ............ 36

Insulin Assays h121i (USP) .................... 554

Iobenguane I 131 Injection (USP) ................ 238

Lipid Injectable Emulsion (USP) ................. 1425

Mannitol Injection (USP) ..................... 896

Metoprolol Succinate (USP) ................... 238

Oxprenolol Hydrochloride Extended-Release Tablets (USP) . 1424

Oxytocin (USP) ........................... 1424

Particulate Matter in Injections h788i (USP) .......... 238

Propoxyphene Napsylate and Aspirin Tablets (USP) ...... 897

Propoxyphene Napsylate Tablets (USP) ............. 238

Pharmacopeial Forum

Vol. 34(6) [Nov.–Dec. 2008]

INDEX 1655

Index

Pyridoxine Hydrochloride Tablets (USP) ............ 1131

Residual Solvents h467i (USP) .................. 238

Riboﬂavin Tablets (USP) ..................... 1131

Rubidium Chloride Rb 82 Injection (USP) ........... 1425

Sterile Puriﬁed Water (USP) ................... 1425

Sterile Water for Inhalation (USP) ................ 1425

Sterile Water for Irrigation (USP) ................ 1425

Thiamine Hydrochloride (USP) .................. 1131

Trace Elements Injection (USP) ................. 1424

Triazolam (USP) .......................... 36

Tribasic Calcium Phosphate (NF) ................ 895

USP General Notices and Requirements ............ 554

Vancomycin Hydrochloride (USP) ................ 36, 897

Errata List for USP 32–NF 27

Polyvinyl Alcohol (USP)

..................... 1425

Expert Committee Designations ...................13, 213, 523, 869, 1101, 1377

Food Chemicals Codex Sixth Edition Now Available .......220, 530

Harmonization

Butylparaben (NF)

......................... 1592

Dextrose (USP) ........................... 1585

Ethylparaben (NF) ......................... 1594

Hydroxyethyl Cellulose (NF) ................... 1595

Mannitol (USP) ........................... 1588

Methylparaben (NF) ........................ 1601

Propylparaben (NF) ........................ 1603

Harmonization Introduction .....................833, 1063, 1339, 1583

How to Use PF .............................9, 209, 519, 865, 1097, 1373

Immediate IRA Commentary: Interim Revision Announcement for

Alendronic Acid Tablets, Title Change

.............. 20

Interim Revision Announcements ..................31, 231, 541, 887, 1119, 1395

Interim Revision Announcement for Oxybutynin Chloride,

Deﬁnition

............................... 21

IPR Introduction ............................37, 239, 555, 899, 1133, 1427

IRA Commentary ........................... 530

IRA Introduction ............................31, 231, 541, 887, 1119, 1395

The Journal of Standards Development and Ofﬁcial Compendia

Revision

...............................4, 204, 514, 860, 1092, 1367

Nomenclature

Introduction

.............................189, 505, 849, 1079, 1357, 1641

Newly Approved USAN, Released for Publication .......190, 1080, 1642

Proposed and Recommended International Nonproprietary

Names

...............................850, 1081, 1647

Revisions of United States Adopted Names (USAN) .....1080, 1647

Supplement 2, 2008 USP Dictionary ............... 1080

Supplement 4, 2008 USP Dictionary ............... 1642

Supplement 5, 2007 USP Dictionary ............... 190

Pharmacopeial Education .......................220, 530

Pharmacopeial Forum Public Review and Comment Period

Deadlines

...............................21, 221, 531, 876, 1108, 1385

Policies and Announcements

Cautionary Statements Added to Black Cohosh-related

Monographs

........................... 220

Food Chemicals Codex Sixth Edition Now Available .....220, 530

Immediate IRA Commentary: Interim Revision Announcement

for Alendronic Acid Tablets, Title Change

.......... 20

Interim Revision Announcement for Oxybutynin Chloride,

Deﬁnition

............................. 21

IRA Commentary .......................... 530

Pharmacopeial Education .....................220, 530

Pharmacopeial Forum Public Review and Comment Period

Deadlines

.............................21, 221, 531, 876, 1108, 1385

Pravastatin Sodium Tablets Dissolution Direct IRA ...... 220

Priority New Monograph Items ..................22, 222, 532, 877, 1109, 1385

Residual Solvents: General Notices and

General Chapter h467i

.....................530, 876, 1108

Stimuli Article Proposes Changes to Heavy Metals/Inorganic

Impurities General Chapter

................... 1108

Stimuli Articles Posted on USP’s Website ............21, 220, 530

Use of USP Website ........................876, 1108, 1384

USP Announces a Revised Monograph to Levothyroxine Sodium

Tablets

.............................. 1384

USP Catalog Available .......................21, 220, 530

2008 USP Dictionary—Just Published .............. 530

USP Launches New Series of Professional Education Courses 20

USP Proposes Changes to General Chapter h711i

Dissolution

............................1108, 1384

USP Rules and Procedures of the Council of Experts Revised,

Reﬂecting Changes to the Standards-Setting Process

.... 20

Visit the USP Website at http://www.usp.org ..........21, 221, 531

Pravastatin Sodium Tablets Dissolution Direct IRA ........ 220

Previews ................................183, 469

Previous PF Proposals Still Pending .................168, 451, 818, 1048, 1323, 1567

Priority New Monograph Items ...................22, 222, 532, 877, 1109, 1385

Residual Solvents: General Notices and

General Chapter h467i

.......................530, 876, 1108

Section Descriptions ..........................10, 210, 520, 866, 1098, 1374

Staff Directory .............................15, 215, 525, 871, 1103, 1379

Standards Development ........................5, 205, 515, 861, 1093, 1369

Stimuli to the Revision Process

The Cadaver Skin Absorption Model and the Drug Development

Process

.............................. 1349

Compendial Calculations: Recommendations for Improving

USP–NF calculations

...................... 1619

Description of the Upcoming Change in Data Analysis for USP

Dissolution Performance Veriﬁcation Tests

.......... 1630

General Chapter Containers—Packaging Auxiliary Components

h670i

............................... 1628

General Chapter on Inorganic Impurities: Heavy Metals ... 1345

The Inhalation Ad Hoc Advisory Panel for the USP Performance

Tests of Inhalation Dosage Forms

............... 1068

The Inhalation Ad Hoc Advisory Panel for the USP Performance

Tests of Inhalation Dosage Forms, Correction

........ 1344

Instructions to Authors .......................187, 473, 837, 1067, 1343, 1607

Making Sense of Trueness, Precision, Accuracy, and

Uncertainty

............................ 838

Product Performance Test for Medicated Chewing Gums ... 843

Redesign of the United States Pharmacopeia and National

Formulary

............................ 1638

Revision of USP General Chapter h381i Elastomeric Closures

for Injection

........................... 482

Uncertainty Statements Regarding USP Reference Standards . 477

The Use of Inductively Coupled Plasma–Optical Emission

Spectroscopy in the Determination of Heavy Metals in

Crospovidone and Povidone as a Replacement for the

Concomitant Visual Comparison Test

............. 1613

Use of Scanning Electron Microscopy in the Authentication of

Botanicals

............................ 1075

USP Responses to Comments on Stimuli Article, ‘‘Proposed

Change to Acceptance Criteria for Dissolution Performance

Veriﬁcation Testing’’

...................... 474

USP Responses to Comments on Stimuli Article, ‘‘The

Application of Uncertainty to USP’s Compendial Reference

Standards Program: Certiﬁed Reference Materials’’

..... 1608

USP Responses to Comments on Stimuli Article, ‘‘Uncertainty

Statements Regarding USP Reference Standards’’

...... 1636

Stimuli Article Proposes Changes to Heavy Metals/Inorganic

Impurities General Chapter

..................... 1108

Stimuli Articles Posted on USP’s Website .............21, 220, 530

Stimuli Introduction ..........................185, 471, 835, 1065, 1341, 1605

Use of USP Website ..........................876, 1108, 1384

USP Announces a Revised Monograph to Levothyroxine Sodium

Tablets

................................ 1384

USP Catalog Available ........................21, 220, 530

2008 USP Dictionary—Just Published ............... 530

USP Launches New Series of Professional Education Courses . 20

USP Proposes Changes to General Chapter h711i Dissolution ..1108, 1384

USP Rules and Procedures of the Council of Experts Revised,

Reﬂecting Changes to the Standards-Setting Process

...... 20

Visit the USP Website at http://www.usp.org ............21, 221, 531

Pharmacopeial Forum

1656

INDEX Vol. 34(6) [Nov.–Dec. 2008]

Index

[Note—This index covers Vol. 35 No. 1, pp. 1–218; Vol. 35

No. 2, pp. 219–498 ; Vol. 35 No. 3, pp. 499–784; Vol. 35

No. 4, pp. 785–1050; Vol. 35 No. 5, pp. 1051–1408; Vol.

35 No. 6, pp. 1409–1638.]

MONOGRAPHS

Acetaminophen and Tramadol Hydrochloride Tablets (USP) 56

Acetyltributyl Citrate (NF) .................... 1495

N-Acetyltyrosine (USP) ...................... 107

Acitretin (USP) ........................... 1102

Acitretin Capsules (USP) ..................... 1095

Medical Air (USP) ......................... 828

Alendronate Sodium Tablets (USP) ............... 59

Alprazolam Tablets (USP erratum) ............... 51

Amantadine Hydrochloride Capsules (USP) ..........61, 531

Amlodipine Besylate Tablets (USP) ............... 62

Ampicillin Sodium (USP) ..................... 65

Amylene Hydrate (NF) ...................... 903

Andrographis (USP) ........................ 1183

Powdered Andrographis (USP) ................. 1184

Powdered Andrographis Extract (USP) ............. 1186

Articaine Hydrochloride (USP) .................. 544

Ashwagandha (USP) ....................... 885

Powdered Ashwagandha (USP) ................. 886

Powdered Ashwagandha Extract (USP) ............ 888

Atenolol (USP) ........................... 545

Atenolol Tablets (USP) ...................... 66

Atorvastatin Calcium (USP) ................... 66

Atropine Sulfate (USP) ...................... 829

Aztreonam (USP) ......................... 1103

Bacitracin (USP erratum) ..................... 535

Soluble Bacitracin Methylene Disalicylate (USP) ....... 1105

Bacitracin Methylene Disalicylate Soluble Powder (USP) .. 1106

Bacitracin Zinc (USP erratum) .................. 535

Balsalazide Disodium (USP) ................... 830

Balsalazide Disodium Capsules (USP) .............. 832

Bendroﬂumethiazide Tablets (USP) ............... 1106

Benzalkonium Chloride (NF) ................... 1496

Benzalkonium Chloride Solution (NF) ............. 1499

Benzethonium Chloride (USP) .................. 833

Benzoin (USP) ........................... 70

Benzyl Alcohol (NF) ........................ 685

Betadex (NF erratum) ....................... 1090

Betamethasone Oral Solution (USP erratum) ......... 822

Bicalutamide (USP) ........................ 1107

Biperiden Hydrochloride Tablets (USP) ............. 1108

Boswellia Serrata (USP) ...................... 890

Boswellia Serrata Extract (USP) ................. 891

Budesonide (USP) .........................539, 1085

Bupropion Hydrochloride Extended-Release Tablets (USP

erratum)

............................. 254

Bupropion Hydrochloride Extended-Release

Tablets (USP)

...........................70, 531, 1109

Butylated Hydroxyanisole (NF) ................. 1503

Butylated Hydroxytoluene (NF erratum) ............ 818

Butyl Stearate (NF) ........................ 1502

Calcium and Vitamin D with Minerals Tablets (USP erratum) 534

Calcium with Vitamin D Tablets (USP) ............. 1486

Capecitabine (USP) ........................ 834

Capecitabine Tablets (USP) ...................72, 835, 1113

Capreomycin Sulfate (USP) ................... 1448

Capreomycin for Injection (USP) ................ 1449

Carbidopa (USP) .......................... 73

Carbomer 934P (NF erratum) .................. 51

Carbomer Copolymer (NF erratum) .............. 51

Carmellose (NF) .......................... 1018

Carmustine (USP) ......................... 546

Carmustine for Injection (USP) ................. 548

Carprofen Tablets (USP erratum) ................ 535

Cefazolin (USP erratum) ..................... 51

Cefdinir Capsules (USP) ...................... 1115

Cefdinir for Oral Suspension (USP) ............... 1118

Cefdinir for Oral Suspension (USP erratum) .......... 254

Cefotaxime for Injection (USP erratum) ............ 535

Cefotetan for Injection (USP) .................. 1122

Cefprozil (USP erratum) ..................... 818

Cefuroxime Axetil for Oral Suspension (USP) ......... 1123

Chitosan (NF) ........................... 115

Cilostazol Tablets (USP erratum) ................ 254

Ciproﬂoxacin (USP) ........................ 837

Ciproﬂoxacin Hydrochloride (USP) ............... 839

Ciproﬂoxacin Injection (USP) .................. 840

Ciproﬂoxacin Ophthalmic Solution (USP) ........... 842

Ciproﬂoxacin Tablets (USP) ................... 843

Citalopram Hydrobromide Tablets (USP erratum) ...... 819

Citalopram Tablets (USP) ..................... 844

Clarithromycin Tablets (USP) ..................73, 1124

Clenbuterol Hydrochloride (USP) ................ 1125

Clobetasol Propionate (USP) ................... 1125

Clotrimazole (USP) ........................ 1449

Clotrimazole Cream (USP) .................... 1451

Crospovidone (NF) ........................ 671

Crypthecodinium cohnii Oil (USP) ................ 892

Crypthecodinium cohnii Oil Capsules (USP) ........... 1187

Cyclophosphamide (USP) .................... 1126

Cystine (NF) ............................ 122

Dactinomycin for Injection (USP) ................ 1452

Deferoxamine Mesylate (USP) .................. 847

Diclazuril (USP) .......................... 73

Diclofenac Sodium Delayed-Release Tablets (USP) ......271, 1129

Diclofenac Sodium Extended-Release Tablets (USP) ..... 1130

Diethyl Sebacate (NF) ....................... 1203

Diltiazem Hydrochloride Tablets (USP) ............. 1453

Dinoprostone (USP) ........................ 1132

Dinoprost Tromethamine Injection (USP erratum) ...... 254

Disulﬁram (USP) .......................... 848

Docetaxel (USP) .......................... 1133

Docusate Sodium (USP) ..................... 1095

Dofetilide (USP) .......................... 1135

Dolasetron Mesylate (USP) .................... 272

Dronabinol Capsules (USP) ................... 549

Ensulizole (USP) .......................... 849

Enzacamene (USP erratum) ................... 1441

Epirubicin Hydrochloride (USP) ................. 273

Esomeprazole Magnesium (USP) ................ 550

Estradiol Transdermal System (USP) .............. 1136

Estradiol and Norethindrone Acetate Tablets (USP) ..... 1139

Estradiol Vaginal Inserts (USP erratum) .............1091, 1441

Conjugated Estrogens (USP) ................... 1142

Ethyl Acrylate and Methyl Methacrylate Copolymer Dispersion

(NF)

................................ 123

Ethylene Glycol and Vinyl Alcohol Graft Copolymer (NF) .. 324

Fenoﬁbrate (USP) ......................... 275

Fenoﬁbrate Capsules (USP erratum) .............. 535

Flavoxate Hydrochloride (USP) ................. 1454

Fluconazole Injection (USP) ................... 552

Fluticasone Propionate (USP erratum) ............. 535

Formoterol Fumarate (USP erratum) .............. 1441

Fosinopril Sodium (USP) ..................... 1144

Fosinopril Sodium (USP erratum) ................ 536

Fumaric Acid (NF) ......................... 598

Gadodiamide (USP erratum) ................... 1090

Galantamine Tablets (USP) ....................253, 1145

Glucagon (USP) .......................... 1148

Glucagon for Injection (USP) .................. 1152

L-Glutamic Acid, Hydrochloride (NF) .............. 1203

Glyburide and Metformin Hydrochloride Tablets (USP) ... 1456

Halobetasol Propionate (USP) .................. 1458

Hawthorn Leaf with Flower (USP) ................ 817

Powdered Hawthorn Leaf with Flower (USP) ......... 817

Helium (USP) ............................ 850

Heparin Sodium (USP) ......................257, 1085

Heparin Sodium Injection (USP) .................266, 1088

Hydromorphone Hydrochloride (USP) ............. 1156

Hydromorphone Hydrochloride Oral Solution (USP) ..... 851

Hydroxypropyl Cellulose (NF) ..................124, 672

Low-Substituted Hydroxypropyl Cellulose (NF) ........ 673

Hydroxypropyl Cellulose Ocular System (USP) ........ 852

Isotretinoin Capsules (USP erratum) .............. 1091

Lactobionic Acid (NF) ....................... 904

Anhydrous Lactose (NF) ..................... 1013

Pharmacopeial Forum

1634

INDEX Vol. 35(6) [Nov.–Dec. 2009]

Index

Lamivudine and Zidovudine Tablets (USP) .......... 277

Leﬂunomide (USP) ........................ 1158

Leﬂunomide Tablets (USP) .................... 1159

Levoﬂoxacin (USP) ........................ 1459

Levothyroxine Sodium (USP) .................. 555

Lithium Carbonate Tablets (USP) ................ 1461

Microsized Human Acellular Dermal Matrix (USP) ...... 561

Human Acellular Dermal Matrix (USP) ............. 558

Meﬂoquine Hydrochloride (USP) ................ 1160

Megestrol Acetate Oral Suspension (USP) ........... 75

Meloxicam (USP) ......................... 278

Meloxicam Tablets (USP erratum) ................ 51

Metformin Hydrochloride Tablets (USP erratum) ....... 819

Metformin Hydrochloride Extended-Release Tablets (USP) . 76

Methacrylic Acid Copolymer (NF) ............... 905

Methacrylic Acid Copolymer Dispersion (NF) ......... 124

Methacrylic Acid and Ethyl Acrylate Copolymer (NF) .... 907

Partially-Neutralized Methacrylic Acid and Ethyl Acrylate

Copolymer (NF)

......................... 1204

Methacrylic Acid and Methyl Methacrylate Copolymer (NF) 909

Methylbenzethonium Chloride (USP) ............. 853

Methylcellulose (USP) ....................... 683

Methylphenidate Hydrochloride Extended-Release Tablets

(USP)

...............................1162, 1461

Methylpyrrolidone (NF) ..................... 1205

Metolazone Tablets (USP) .................... 1464

Metoprolol Succinate (USP erratum) .............. 1090

Misoprostol (USP) ......................... 564

Mometasone Furoate Cream (USP) ............... 82

Mometasone Furoate Ointment (USP) ............. 84

Mometasone Furoate Topical Solution (USP) ......... 87

Monensin (USP erratum) ..................... 1090

Morphine Sulfate Extended-Release Capsules (USP) ..... 565

Morphine Sulfate Extended-Release Tablets (USP) ...... 1164

Mycophenolate Mofetil (USP) .................. 89

Mycophenolate Mofetil Capsules (USP) ............ 854

Mycophenolate Mofetil for Injection (USP) .......... 1464

Mycophenolate Mofetil for Oral Suspension (USP) ...... 1466

Mycophenolate Mofetil Tablets (USP) ............. 856

Naratriptan Hydrochloride Oral Suspension (USP) ...... 90

Nateglinide Tablets (USP) .................... 281

Nefazodone Hydrochloride (USP) ................540, 1089

Nevirapine Oral Suspension (USP) ............... 857

Nitrofurantoin (USP) ....................... 92

Nitrofurantoin Capsules (USP) .................. 92

Nitrofurantoin Oral Suspension (USP) ............. 92

Nitrofurantoin Tablets (USP) ................... 92

Nitrogen (NF) ........................... 910

Nitrogen 97 Percent (NF) .................... 911

Nitrous Oxide (USP) ........................ 859

Norepinephrine Bitartrate (USP) ................ 1165

Norethynodrel (USP) ....................... 92

Norgestimate (USP erratum) ................... 1091

Olanzapine Tablets (USP) ..................... 282

Olive Oil (NF) ........................... 126

Olopatadine Hydrochloride (USP) ................ 567

Olopatadine Hydrochloride Ophthalmic Solution (USP) ... 568

Omega-3 Acids Ethyl Esters (USP) ................ 1190

Ondansetron Hydrochloride Oral Suspension (USP erratum) 535

Orlistat (USP) ............................ 1166

Orlistat Capsules (USP) ...................... 1169

Oxaliplatin (USP) ......................... 1467

Oxaliplatin Injection (USP) .................... 284

Oxazepam Capsules (USP) ....................286, 1170

Oxybutynin Chloride Tablets (USP) ............... 93

Oxygen (USP) ........................... 861

Oxygen 93 Percent (USP) .................... 862

Pantoprazole Oral Suspension (USP) .............. 863

Parafﬁn (NF erratum) ....................... 1090

Paramethasone Acetate (USP) .................. 1471

Paramethasone Acetate Tablets (USP) ............. 1472

Pectin (USP) ............................ 287

Penicillamine (USP erratum) ................... 1091

Pentamidine Isethionate (USP) ................. 570

Pentobarbital (USP) ........................ 864

Petrolatum (USP) ......................... 1363

White Petrolatum (USP) ..................... 1364

Liqueﬁed Phenol (USP) ...................... 93

Pilocarpine Hydrochloride (USP) ................ 1473

Polydextrose (NF) ......................... 1206

Hydrogenated Polydextrose (NF) ................ 1210

Polyoxyl 15 Hydroxystearate (NF) ............... 128

Polyoxyl Stearyl Ether (NF) .................... 1504

Polysorbate 80 (NF) ........................ 1019

Polyvinyl Acetate Dispersion (NF) ................ 134

Potassium Bromide (USP erratum) ............... 1441

Praziquantel Tablets (USP) .................... 291

Prednisolone Sodium Phosphate (USP erratum) ....... 820

Prednisolone Sodium Phosphate Injection (USP erratum) .. 820

Prednisolone Sodium Phosphate Ophthalmic Solution (USP

erratum)

............................. 822

Primidone (USP) .......................... 571

Primidone Tablets (USP) ..................... 573

Promethazine Hydrochloride and Codeine Phosphate Oral

Solution (USP)

.......................... 292

Promethazine Hydrochloride and Dextromethorphan

Hydrobromide Oral Solution (USP)

.............. 295

Promethazine and Phenylephrine Hydrochloride Oral Solution

(USP)

............................... 298

Promethazine and Phenylephrine Hydrochloride and Codeine

Phosphate Oral Solution (USP)

................ 301

Propafenone Hydrochloride (USP) ............... 94

Propoxyphene Hydrochloride (USP) .............. 865

Propoxyphene Hydrochloride Capsules (USP) ......... 574

Propranolol Hydrochloride Extended-Release Capsules (USP) 1096

Propylene Glycol Dilaurate (NF) ................. 599

Psyllium Husk (USP) ........................ 304

Quinidine Sulfate Oral Suspension (USP) ........... 1475

Ractopamine Hydrochloride Suspension (USP) ........ 1171

Ramipril Capsules (USP) ..................... 867

Red Clover (USP erratum) .................... 254

Powdered Red Clover Extract (USP erratum) ......... 254

Red Clover Tablets (USP erratum) ................ 254

Repaglinide Tablets (USP) .................... 306

Ribavirin Capsules (USP) ..................... 576

Riluzole (USP) ........................... 1173

Riluzole Tablets (USP) ....................... 1174

Risperidone Oral Solution (USP) ................. 870

Ritonavir (USP) ........................... 95

Rivastigmine Tartrate (USP) ................... 1476

Salmeterol Xinafoate (USP) ................... 307

Saw Palmetto (USP erratum) ................... 535

Schizochytrium Oil (USP) ..................... 894

Schizochytrium Oil Capsules (USP) ............... 1192

Sennosides (USP) ......................... 308

Simethicone Emulsion (USP) ................... 1477

Sodium Fluoride Gel (USP) .................... 1175

Corn Starch (NF) ......................... 687

Potato Starch (NF) ........................ 689

Hydrogenated Starch Hydrolysate (NF) ............ 136

Pea Starch (NF) .......................... 140

Rice Starch (NF) .......................... 690

Wheat Starch (NF) ........................ 692

Sterile Water for Irrigation (USP erratum) ........... 535

Sucrose Palmitate (NF) ...................... 326

Sucrose Stearate (NF) ....................... 328

Sulfadiazine Tablets (USP) .................... 577

Sulfasalazine (USP) ........................ 1478

Sulfasalazine Tablets (USP) .................... 1479

Sulﬁnpyrazone (USP) ....................... 577

Sumatriptan Tablets (USP) .................... 871

Tacrolimus (USP) ......................... 310

Tacrolimus Capsules (USP) .................... 312

Tamsulosin Hydrochloride (USP) ................ 578

Tartaric Acid (NF) ......................... 1212

Telmisartan (USP) ......................... 580

Telmisartan Tablets (USP) .................... 581

Terazosin Capsules (USP) ..................... 872

Terazosin Tablets (USP) ...................... 874

Terbinaﬁne Hydrochloride (USP) ................ 1480

Terbinaﬁne Oral Suspension (USP) ............... 96

Terbutaline Oral Suspension (USP) ............... 97

Pharmacopeial Forum

Vol. 35(6) [Nov.–Dec. 2009]

INDEX 1635

Index

Tiagabine Hydrochloride Oral Suspension (USP) ....... 98

Ticlopidine Hydrochloride (USP) ................ 582

Ticlopidine Hydrochloride Tablets (USP) ............ 584

Tioconazole (USP) ......................... 875

Tizanidine Tablets (USP) ..................... 585

Tranylcypromine Sulfate (USP) ................. 314

Tranylcypromine Tablets (USP) ................. 587

Trenbolone Acetate (USP) .................... 100

Triethyl Citrate (NF) ........................ 1505

Tromethamine (USP) ....................... 316

Tylosin Injection (USP erratum) ................. 1442

Ursodiol Tablets (USP) ...................... 876

Valacyclovir Hydrochloride (USP) ................ 589

Valacyclovir Tablets (USP) .................... 878

Valganciclovir Hydrochloride (USP erratum) .......... 254

Valproic Acid Capsules (USP) .................. 591

Valrubicin (USP) .......................... 103

Valsartan and Hydrochlorothiazide Tablets (USP) ....... 1176

Vancomycin Hydrochloride (USP) ................ 879

Vancomycin Hydrochloride for Injection (USP) ........ 881

Venlafaxine Tablets (USP) ..................... 1483

Venlafaxine Hydrochloride (USP) ................ 1482

Vincristine Sulfate Injection (USP) ................ 106

Vincristine Sulfate for Injection (USP) .............. 106

Vinpocetine (USP) ......................... 1195

Vitamin A Oral Liquid Preparation (USP) ............ 596

Oil- and Water-Soluble Vitamins with Minerals Tablets (USP

erratum)

............................. 254

Water for Injection (USP) ..................... 316

Sterile Water for Injection (USP erratum) ........... 254

Sterile Water for Inhalation (USP) ................883, 1178

Sterile Water for Injection (USP) ................. 1178

Sterile Water for Irrigation (USP) ................ 1179

Puriﬁed Water (USP) ....................... 317

Sterile Puriﬁed Water (USP) ................... 1180

Water for Hemodialysis (USP) .................. 1485

Zidovudine Oral Solution (USP) ................. 1180

Zinc Gluconate Tablets (USP) .................. 597

Ziprasidone Hydrochloride (USP) ................ 592

Zolpidem Tartrate Tablets (USP) ................. 883

Zolpidem Tartrate Extended-Release Tablets (USP) ...... 595

EXCIPIENTS

Excipients, USP and NF Excipients,

Listed by Category (NF)

....................109, 318, 897, 1197, 1488

GENERAL CHAPTERS

Amphetamine Assay h331i (USP) ................ 920

Articles of Botanical Origin h561i (USP erratum) ....... 254

Bacterial Endotoxins Test h85i (USP) .............. 695

Biological Assay Validation h1033i (USP) ............ 349

Biotechnology-Derived Articles—Amino Acid Analysis h1052i

(USP)

............................... 27

Biotechnology-Derived Articles—Capillary Electrophoresis

h1053i (USP)

........................... 34

Biotechnology-Derived Articles—Isoelectric Focusing h1054i

(USP)

............................... 39

Biotechnology-Derived Articles—Peptide Mapping h1055i

(USP)

............................... 41

Biotechnology-Derived Articles—Polyacrylamide Gel

Electrophoresis h1056i (USP)

................. 46

Biotechnology-Derived Articles—Polyacrylamide Gel

Electrophoresis h1056i (USP erratum)

............ 1441

Bovine Serum h1024i (USP) ................... 628

Bulk Density and Tapped Density h616i (USP) ........ 715

Bulk Powder Sampling Procedures h1097i (USP) ....... 367

Characterization of Crystallinity Determination by Solution

Calorimetry h696i (USP)

.................... 675

Chromatography h621i (USP) .................. 1516

Containers—Glass h660i (USP erratum) ............ 51

Dimethylaniline h223i (USP) ................... 156

Disinfectants and Antiseptics h1072i (USP) .......... 1250

Disintegration and Dissolution of Dietary Supplements h2040i

(USP)

...............................984, 1561

Dissolution h711i (USP) ..................... 719

Elastomeric Closures for Injections h381i (USP) ........614, 1225

Elastomeric Closures for Injections h381i (USP erratum) ..51, 1441

Ethylene Oxide and Dioxane h228i (USP) ........... 917

Excipient Performance h1059i (USP) .............. 1228

Fetal Bovine Serum Quality Attributes and Functionality Tests

h90i (USP)

............................ 1219

Globule Size Distribution in Lipid Injectable Emulsions h729i

(USP)

............................... 626

Good Compounding Practices h1075i (USP) ......... 942

Growth Factors and Cytokines Used in Cell Therapy

Manufacturing h92i (USP)

................... 915

Human Plasma h1180i (USP) .................. 388

Impurities in Ofﬁcial Articles h1086i (USP) ........... 1254

Impurities Testing in Medical Gases h413i (USP) ....... 920

Injections h1i (USP) ........................601, 1214

Light Diffraction Measurement of Particle Size h429i (USP) . 707

Manufacturing Practices for Dietary Supplements h2750i

(USP)

............................... 1319

Medical Gases Assay h415i (USP) ................ 921

Melting Range or Temperature h741i (USP) .......... 925

Methods for the Particulate Matter Determination in

Parenteral and Ophthalmic Products h1788i (USP)

.... 1533

Microbial Identiﬁcation h1113i (USP) ............. 167

Microbiological Best Laboratory Practices h1117i (USP) ... 945

Mycoplasma Tests h63i (USP) .................. 146

Nomenclature h1121i (USP) ................... 1529

Particle Size Distribution Estimation by Analytical Sieving

h786i (USP erratum)

...................... 1090

Particulate Matter in Injections h788i (USP) .......... 628

Particulate Matter in Injections h788i (USP erratum) ..... 818

Pharmaceutical Compounding—Nonsterile Preparations

h795i (USP)

............................ 926

Pharmaceutical Dosage Forms h1151i (USP) ......... 1260

Repackaging into Single-Unit Containers and Unit-Dose

Containers for Nonsterile Solid and Liquid Dosage Forms

h681i (USP erratum)

...................... 51

Residual Solvents h467i (USP) .................. 334

Spectrophotometric Identiﬁcation Tests h197i (USP) .... 152

Spectrophotometry and Light-Scattering h851i (USP) .... 157

Sterility Tests h71i (USP erratum) ................ 1441

Sterilization and Sterility Assurance of Compendial Articles

h1211i (USP)

........................... 952

Sulfonamides h521i (USP) .................... 1515

Sulfur Dioxide h525i (USP) .................... 341

Supplemental Information for Articles of Botanical Origin

h2030i (USP)

........................... 1551

Topical and Transdermal Drug Products—Product

Performance Tests h725i (USP)

................ 615

Topical and Transdermal Drug Products—Product Quality

Tests h3i (USP)

.......................... 602

Uniformity of Dosage Units h905i (USP) ............ 724

USP Reference Standards h11i (USP erratum) .........51, 536, 1441

USP Reference Standards h11i

(USP)

...............................144, 330, 612, 913, 1217, 1507

Vaccines for Human Use—General Considerations h1235i

(USP)

............................... 960

Validation of Compendial Procedures h1225i (USP) ..... 444

Water Conductivity h645i (USP) ................ 1226

Water Determination h921i (USP) ............... 346

Water for Health Applications h1230i (USP) .......... 1531

Water for Pharmaceutical Purposes h1231i (USP) ...... 1310

Weighing on an Analytical Balance h1251i (USP) ...... 448

Weights and Balances h41i (USP) ................ 331

X-Ray Diffraction h941i (USP) .................. 731

REAGENTS, INDICATORS, AND SOLUTIONS

Reagents, Indicators, and Solutions, Introduction ...... 176

Chromatographic Reagents (USP) ...............182, 1340

Indicator Test Papers

Mercuric Bromide Test Paper (USP)

............. 1568

Reagent Speciﬁcations

Alcohol (USP)

.......................... 177

Ammonium Bicarbonate (USP) ................ 1567

Ammonium Molybdate (USP) ................ 177

t-Butylthiol (USP) ........................ 648

Calcium Acetate (USP) ..................... 990

2-Chloroethanol (USP) ..................... 1567

Pharmacopeial Forum

1636

INDEX Vol. 35(6) [Nov.–Dec. 2009]

Index

Chromotropic Acid (USP) ................... 177

Chromotropic Acid Disodium Salt (USP) .......... 177

Alpha-Chymotrypsin (USP) .................. 1567

Cobalt Chloride (USP) ..................... 1339

Cobalt Nitrate (USP) ...................... 648

Decanol (USP erratum) .................... 1090

Diaveridine (USP) ........................ 648

1,3-Dicaffeoylquinic Acid (USP) ............... 990

Glycolic Acid (USP) ....................... 1567

Heptyl p-Hydroxybenzoate (USP) .............. 460

Lead Acetate Cotton (USP) .................. 1568

Methyl Red (USP) ....................... 177

Nitrogen Certiﬁed Standard (USP) .............. 990

Oxygen Certiﬁed Standard (USP) .............. 1339

93.0% Oxygen Certiﬁed Standard (USP) .......... 991

Oxygen-Helium Certiﬁed Standard (USP) .......... 991

Oxygen in Nitrogen Certiﬁed Standard (USP) ....... 991

3.0% Oxygen in Nitrogen Certiﬁed Standard (USP) ... 991

21.0% Oxygen in Nitrogen Certiﬁed Standard (USP) .. 991

Pectate Lyase (USP) ...................... 460

Phosphorous Acid (USP) .................... 178

p-Naphtholbenzein (USP) ................... 648

Potassium Arsenate Monobasic (USP) ............ 1568

Potassium Metabisulﬁte (USP) ................ 178

Potassium Sodium Tartrate (USP) .............. 178

Sodium Acetate (USP) ..................... 461

Sodium Biphenyl (USP) ....................178, 648

Stannous Chloride (USP) ................... 649

Sulfuric Acid, Nitrogen Free (USP) .............. 649

Delta-8-Tetrahydrocannabinol (USP) ............ 991

Tetramethylbenzidine (USP) ................. 1339

Water, Ammonia-Free, H

O (USP erratum) ......... 254

Zinc, Activated (USP) ..................... 1568

Test Solutions

Acetic Acid, Glacial (USP)

................... 179

Cupric Citrate TS 2, Alkaline (USP) .............. 179

Denaturated Alcoholic TS (USP) ............... 179

Dibasic Sodium Phosphate TS (USP) ............ 649

Lead Subacetate TS (USP) ................... 1339

Starch TS (USP) ......................... 1340

Volumetric Solutions

Hydrochloric Acid, Half-Normal (0.5 N) (USP)

....... 180

Hydrochloric Acid, Half-Normal (0.5 N) in Methanol (USP) 180

Hydrochloric Acid, Normal (1 N) (USP) ........... 180

Perchloric Acid, Tenth-Normal (0.1 N) in Dioxane (USP) . 180

Perchloric Acid, Tenth-Normal (0.1 N) in Glacial Acetic Acid

(USP)

............................. 181

REFERENCE TABLES

Atomic Weights (USP) ...................... 189

Container Speciﬁcations (USP) .................186, 462, 650, 992, 1341, 1569

Description and Solubility (USP) ................188, 464, 651, 993, 1343, 1571

Description and Solubility (USP erratum) ...........534, 1090

GENERAL SUBJECTS

Call for Candidates for 2010–2015 Council of Experts, Its

Expert Committees, and Its Expert Panels. Application

Deadline for Committee Chairs: December 18, 2009.

... 1428

Canceled Proposals ........................208, 481, 668, 1010, 1359, 1589

Cumulative Editions ........................ 1428

Errata List for USP 31–NF 26

Alprazolam Tablets (USP)

................... 51

Biotechnology-Derived Articles—Polyacrylamide Gel

Electrophoresis h1056i (USP)

............... 1441

Carbomer 934P (NF) ..................... 51

Carbomer Copolymer (NF) .................. 51

Cefazolin (USP) ......................... 51

Containers—Glass h660i (USP) ................ 51

Enzacamene (USP) ....................... 1441

Formoterol Fumarate (USP) .................. 1441

Potassium Bromide (USP) ................... 1441

Repackaging into Single-Unit Containers and Unit-Dose

Containers for Nonsterile Solid and Liquid Dosage Forms

h681i (USP)

.......................... 51

Sterility Tests h71i (USP) .................... 1441

Tylosin Injection (USP) ..................... 1442

USP Reference Standards h11 i (USP) ............ 51

Errata List for USP 32–NF 27

Articles of Botanical Origin h561i (USP)

........... 254

Bacitracin (USP) ......................... 535

Bacitracin Zinc (USP) ...................... 535

Betadex (NF) .......................... 1090

Betamethasone Oral Solution (USP) ............. 822

Bupropion Hydrochloride Extended-Release Tablets (USP) 254

Butylated Hydroxytoluene (NF) ............... 818

Calcium and Vitamin D with Minerals Tablets (USP) ... 534

Carprofen Tablets (USP) .................... 535

Cefdinir for Oral Suspension (USP) ............. 254

Cefotaxime for Injection (USP) ................ 535

Cefprozil (USP) ......................... 818

Cilostazol Tablets (USP) .................... 254

Citalopram Hydrobromide (USP) .............. 819

Decanol (USP) ......................... 1090

Description and Solubility (USP) ...............534, 1090

Dinoprost Tromethamine Injection (USP) .......... 254

Elastomeric Closures for Injections h381i (USP) ......51, 1441

Estradiol Vaginal Inserts (USP) ................1091, 1441

Fenoﬁbrate Capsules (USP) .................. 535

Fluticasone Propionate (USP) ................. 535

Fosinopril Sodium (USP) .................... 536

Gadodiamide (USP) ...................... 1090

Isotretinoin Capsules (USP) .................. 1091

Meloxicam Tablets (USP) ................... 51

Metformin Hydrochloride Tablets (USP) .......... 819

Metoprolol Succinate (USP) .................. 1090

Monensin (USP) ........................ 1090

Norgestimate (USP) ...................... 1091

Ondansetron Hydrochloride Oral Suspension (USP) ... 535

Parafﬁn (NF) ........................... 1090

Particle Size Distribution Estimation by Analytical Sieving

h786i (USP)

.......................... 1090

Particulate Matter in Injections h788i (USP) ........ 818

Penicillamine (USP) ....................... 1091

Prednisolone Sodium Phosphate (USP) ........... 820

Prednisolone Sodium Phosphate Injection (USP) ..... 820

Prednisolone Sodium Phosphate Ophthalmic Solution

(USP)

............................. 822

Red Clover (USP) ........................ 254

Powdered Red Clover Extract (USP) ............. 254

Red Clover Tablets (USP) ................... 254

Saw Palmetto (USP) ...................... 535

Sterile Water for Irrigation (USP) ............... 535

USP Reference Standards h11 i (USP) ............ 536

Valganciclovir Hydrochloride (USP) ............. 254

Oil- and Water-Soluble Vitamins with Minerals Tablets

(USP)

............................. 254

Water, Ammonia-Free, H

O (USP) .............. 254

Sterile Water for Injection (USP) ............... 254

Harmonization Introduction ...................209, 483

Harmonization Introduction, Stage 4 .............669, 1011, 1361, 1591

Harmonization Introduction, Stage 6 .............681, 1015, 1367, 1593

Harmonization Stage 4

Characterization of Crystallinity Determination by Solution

Calorimetry h696i (USP)

.................. 675

Crospovidone (NF) ....................... 671

Hydroxypropyl Cellulose (NF) ................124, 672

Low-Substituted Hydroxypropyl Cellulose (NF) ...... 673

Anhydrous Lactose (NF) .................... 1013

Petrolatum (USP) ........................ 1363

White Petrolatum (USP) .................... 1364

Harmonization Stage 6

Bacterial Endotoxins Test h85i (USP)

............ 695

Benzyl Alcohol (NF) ...................... 685

Bulk Density and Tapped Density h616i (USP) ....... 715

Carmellose (NF) ........................ 1018

Description and Solubility (USP) ............... 1022

Dissolution h711i (USP) .................... 719

Excipients, USP and NF Excipients, Listed by Category

(NF)

.............................. 1017

Light Diffraction Measurement of Particle Size h429i(USP) 707

Methylcellulose (USP) ..................... 683

Pharmacopeial Forum

Vol. 35(6) [Nov.–Dec. 2009]

INDEX 1637

Index

Polysorbate 80 (NF) ...................... 1019

Corn Starch (NF) ........................ 687

Potato Starch (NF) ....................... 689

Rice Starch (NF) ........................ 690

Wheat Starch (NF) ....................... 692

Uniformity of Dosage Units h905i (USP) .......... 724

USP Reference Standards h11i (USP) ............ 1022

X-Ray Diffraction h941i (USP) ................ 731

How to Use PF ...........................9, 227, 507, 793, 1059, 1417

IPR Introduction ..........................53, 269, 541, 825, 1099, 1445

IRA Introduction ..........................23, 249, 527, 813, 1081, 1437

The Journal of Standards Development and Ofﬁcial

Compendia Revision

......................4, 221, 502, 788, 1054, 1411

Nomenclature

Introduction

...........................213, 493, 779, 1043, 1389, 1627

Newly Approved USAN, Released for Publication .....1391, 1629

Proposed and Recommended International Nonproprietary

Names

............................. 1399

Supplement 3, 2009 USP Dictionary ............ 1391

Supplement 4, 2009 USP Dictionary ............ 1629

Pharmacopeial Forum Public Review and Comment Period

Deadlines

.............................21, 239, 518, 804, 1071

Policies and Announcements

Call for Candidates for 2010–2015 Council of Experts, Its

Expert Committees, and Its Expert Panels. Application

Deadline for Committee Chairs: December 18, 2009.

. 1428

Cumulative Editions ...................... 1428

Pharmacopeial Forum Public Review and Comment Period

Deadlines

...........................21, 239, 518, 804, 1071

Priority New Monograph Items ...............21, 240, 519, 805, 1072

Stage 4 and Stage 6 Harmonized Standards Are Now

Featured in Two Separate PF Sections

.......... 518

USP Announces Chromatographic Reagents Is Now Called

Chromatographic Columns

................ 1070

USP Announces Revisions to Galantamine Tablets ..... 239

USP Announces Revision to Amantadine Hydrochloride

Capsules Monograph

.................... 518

USP Announces Revision to Budesonide Monograph ... 1070

USP Announces Revision to Bupropion Hydrochloride

Extended-Release Tablets Monograph

.......... 518

USP Announces Revision to Hawthorn Monographs ... 804

USP Announces Revision to Nefazodone Hydrochloride

Monograph

......................... 1070

USP Implements Guideline on the Use of Accelerated

Processes for Revisions to the USP–NF

..........20, 238

USP Issues Call for Candidates for 2010–2015 Council of

Experts, Its Expert Committees, and

Its Advisory Panels

......................20, 238, 804, 1070

USP Posts Commentary to Interim Revision

Announcements on the USP Web Site

..........804, 1428

USP Redesigns Pharmacopeial Forum .............20, 238

USP Revises General Notices in USP 32–NF 27 ....... 20

Previous PF Proposals

Still Pending

...........................193, 465, 653, 995, 1345, 1573

Priority New Monograph Items .................21, 240, 519, 805, 1072

Proposed IRA Intro Section ....................255, 537, 823, 1093, 1443

Stage 4 and Stage 6 Harmonized Standards Are Now Featured

in Two Separate PF Sections

.................. 518

Standards Development .....................5, 223, 503, 789, 1055, 1413

Stimuli Introduction ........................211, 485, 741, 1023, 1369, 1595

Stimuli to the Revision Process

Acceptable, Equivalent, or Better: Approaches for

Alternatives to Ofﬁcial Compendial Procedures

..... 772

Co-Processed Excipients .................... 1026

A Discussion of Net Water Gain for Water Vapor

Transmission Rate Determinations

............ 488

Drug Product Performance and Interchangeability of

Multisource Drug Substances and Drug Products

... 744

General Chapter Management in the 2010–2015 Cycle . 1372

Liquid-ﬁlled Gelatin Capsules ................. 1029

Performance-based Monographs .............. 765

Pharmacopeial Standards for the Subdivision

Characteristics of Scored Tablets

............. 1598

A Recombinant Factor C Procedure for the Detection of

Gram-negative Bacterial Endotoxin

............ 1613

Topical and Transdermal Drug Products .......... 750

Transfer of Analytical Procedures–A Proposal for a New

General Information Chapter

............... 1380

Transfer of HPLC Procedures to Suitable Columns of

Reduced Dimensions and Particle Sizes

......... 1622

Visible Particulates in Injections—A History and a Proposal

to Revise USP General Chapter Injections h1i

...... 1383

USP Announces Revisions to Galantamine Tablets ...... 239

USP Announces Revision to Amantadine Hydrochloride

Capsules Monograph

...................... 518

USP Announces Revision to Budesonide Monograph .... 1070

USP Announces Revision to Bupropion Hydrochloride

Extended-Release Tablets Monograph

............ 518

USP Announces Chromatographic Reagents Is Now Called

Chromatographic Columns

.................. 1070

USP Announces Revision to Hawthorn Monographs ..... 804

USP Announces Revision to Nefazodone Hydrochloride

Monograph

........................... 1070

USP Implements Guideline on the Use of Accelerated

Processes for Revisions to the USP–NF

............20, 238

USP Issues Call for Candidates for 2010–2015 Council of

Experts, Its Expert Committees, and

Its Advisory Panels

........................20, 238, 804, 1070

USP Posts Commentary to Interim Revision Announcements

on the USP Website

.......................804, 1428

USP Redesigns Pharmacopeial Forum ..............20, 238

USP Revises General Notices in USP 32–NF 27 ........ 20

Pharmacopeial Forum

1638

INDEX Vol. 35(6) [Nov.–Dec. 2009]

Index

[Note—This index covers Vol. 36 No. 1, pp. 1–335; Vol. 36

No. 2, pp. 337–608 ; Vol. 36 No. 3, pp. 609–840; Vol. 36

No. 4, pp. 841–1096; Vol. 36 No. 5, pp. 1097-1432; and

Vol. 36 No. 6, pp. 1433–1822.]

GENERAL NOTICES

USP General Notices and Requirements ............ 56

USP General Notices and Requirements (USP erratum) ... 879

MONOGRAPHS

Abacavir Sulfate (USP) ...................... 651

Abacavir Oral Solution (USP) .................. 652

Abacavir Tablets (USP) ...................... 654

Glacial Acetic Acid (USP) .....................645, 1137

Acitretin Capsules (USP) ..................... 33

Ademetionine Disulfate Tosylate (USP) ............. 438

S-Adenosyl-L-methionine Disulfate (USP) ............ 438

Alclometasone Dipropionate (USP) ............... 1156

Alendronate Sodium Tablets (USP) ............... 1157

Alfuzosin Hydrochloride Extended-Release Tablets (USP) .. 889

Alprazolam Extended-Release Tablets (USP) .......... 655

Alprazolam Orally Disintegrating Tablets (USP) ........ 890

Aluminum Oxide (NF) ...................... 190

Amifostine (USP) .......................... 62

Amifostine for Injection (USP) .................. 63

Amiodarone Hydrochloride (USP erratum) .......... 1140

Amlodipine Besylate Tablets (USP) ............... 376

Ammonio Methacrylate Copolymer (NF) ........... 1631

Ammonium Molybdate (USP) .................. 1159

Amoxicillin (USP) ......................... 66

Amoxicillin Capsules (USP) .................... 892

Amoxicillin for Oral Suspension (USP) ............. 894

Amoxicillin Tablets (USP) ..................... 896

Amoxicillin and Clavulanate Potassium for Oral Suspension

(USP)

............................... 899

Amoxicillin and Clavulanate Potassium Tablets (USP) .... 901

Amphetamine Sulfate (USP) ................... 68

Anagrelide Hydrochloride (USP) ................. 1160

Anagrelide Capsules (USP) .................... 1162

Antihemophilic Factor (USP) ................... 1163

Cryoprecipitated Antihemophilic Factor (USP) ........ 1164

Antivenin (Crotalidae) Polyvalent (USP) ............ 1164

Antivenin (Latrodectus mactans) (USP) ............ 1165

Antivenin (Micrurus fulvius) (USP) ............... 1165

Arginine Capsules (USP) ..................... 147

Arginine Tablets (USP) ...................... 147

Artemether (USP) ......................... 377

Artemether and Lumefantrine Tablets (USP) ......... 379

Ascorbyl Palmitate (NF) ...................... 447

Azithromycin (USP) ........................ 70

Azithromycin for Injection (USP erratum) ...........642, 1473

Aztreonam (USP) ......................... 1496

Bacitracin Ointment (USP erratum) ............... 641

Bacopa (USP) ........................... 691

Powdered Bacopa (USP) ..................... 692

Powdered Bacopa Extract (USP) ................. 694

Benzalkonium Chloride (USP erratum) ............. 37

Benzalkonium Chloride Solution (USP erratum) ....... 641

Hydrous Benzoyl Peroxide (USP) ................ 382

Beta Carotene (USP) ....................... 1498

Beta Carotene Preparation (USP) ................ 1583

Betadex Sulfobutyl Ether Sodium (NF) ............. 447

Bicalutamide (USP) ........................ 1165

Bisoprolol Fumarate Tablets (USP) ............... 1500

Red Blood Cells (USP) ....................... 1501

Blood Grouping Serums (USP) ................. 1168

Blood Grouping Serums Anti-D, Anti-C, Anti-E, Anti-c, Anti-e

(USP)

............................... 1168

Anti-A Blood Grouping Serum (USP) .............. 1169

Anti-B Blood Grouping Serum (USP) .............. 1170

Whole Blood (USP) ........................ 1170

Botulism Antitoxin (USP) ..................... 1172

Bromocriptine Mesylate (USP) .................. 1173

Budesonide (USP) ......................... 1504

Bupropion Hydrochloride (USP) ................. 383

Bupropion Hydrochloride (USP erratum) ........... 37

Bupropion Hydrochloride Extended-Release Tablets (USP) . 906

Buspirone Hydrochloride (USP) ................. 74

Cabergoline (USP) ......................... 75

Calcitonin Salmon (USP) ..................... 1174

Candesartan Cilexetil (USP) ................... 1506

Capsicum Oleoresin (USP erratum) ............... 1473

Carmustine for Injection (USP) ................. 1508

Cat’s Claw Capsules (USP) .................... 148

Cat’s Claw Tablets (USP) ..................... 149

Cefaclor Capsules (USP erratum) ................ 642

Cefadroxil for Oral Suspension (USP) .............. 385

Cefazolin (USP erratum) ..................... 641

Cefdinir (USP) ........................... 1509

Cefdinir Capsules (USP) ......................386, 1511

Cefdinir Capsules (USP erratum) ................ 1474

Cefdinir for Oral Suspension (USP) ............... 1515

Cefepime Hydrochloride (USP) ................. 76

Cefepime for Injection (USP) ................... 79

Ceftazidime for Injection (USP erratum) ............ 641

Cefuroxime Axetil for Oral Suspension (USP erratum) .... 875

Celecoxib (USP) .......................... 1519

Centella asiatica (USP) ....................... 941

Centella asiatica Triterpenes (USP) ................ 946

Powdered Centella asiatica (USP) ................ 943

Powdered Centella asiatica Extract (USP) ............ 944

Cephalexin (USP) .........................41, 1131

Cephalexin Hydrochloride (USP) ................42, 1136

Cephalexin Capsules (USP) ....................44, 1132

Cephalexin for Oral Suspension (USP) .............45, 1133

Cephalexin Tablets (USP) .....................46, 1134

Cephalexin Tablets for Oral Suspension (USP) ........47, 1135

Cetrizine Hydrochloride (USP erratum) ............ 1474

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Extended-Release Tablets (USP)

................ 82

Cetirizine Hydrochloride Tablets (USP) ............. 389

Chamomile (USP) ......................... 1584

Chlorhexidine Acetate (USP) ................... 85

Chlorhexidine Acetate Topical Solution (USP) ......... 87

Chlorhexidine Gluconate Solution (USP) ............ 88

Chlorhexidine Gluconate Solution (USP erratum) ...... 35

Chlorhexidine Gluconate Topical Solution (USP) ....... 90

Chlorhexidine Hydrochloride (USP) ............... 91

Citalopram Oral Solution (USP) ................. 657

Clarithromycin Tablets (USP erratum) ............. 1141

Clindamycin Hydrochloride (USP) ............... 1520

Clindamycin Palmitate Hydrochloride for Oral Solution (USP

erratum)

............................. 878

Cloprostenol Injection (USP erratum) ............. 35

Coccidioidin (USP) ........................ 1178

Codeine Sulfate (USP) ...................... 909

Codeine Sulfate Tablets (USP) .................. 911

Cod Liver Oil (USP erratum) ................... 35, 37

Black Cohosh Tablets (USP) ................... 150

Cranberry Liquid Preparation (USP) .............. 1586

Desﬂurane (USP) .......................... 93

Diethyl Sebacate (NF) ....................... 1632

Diethylene Glycol Monoethyl Ether (NF) ........... 1633

Diphtheria and Tetanus Toxoids Adsorbed (USP) ....... 1178

Divalproex Sodium (USP) .................... 1178

Divalproex Sodium Delayed-Release Capsules (USP) ..... 390

Divalproex Sodium Extended-Release Tablets (USP) ..... 391

Docusate Sodium (USP) ..................... 33

Donepezil Hydrochloride (USP) ................. 97

Donepezil Hydrochloride Tablets (USP) ............ 658

Donepezil Hydrochloride Orally Disintegrating Tablets (USP) 660

Doxycycline Hyclate Delayed-Release Tablets (USP) ..... 912

Drospirenone (USP) ........................394, 1524

Drospirenone and Ethinyl Estradiol Tablets (USP) ....... 914

Ecamsule Solution (USP erratum) ................ 36, 37

Efavirenz (USP) ........................... 661

Efavirenz Capsules (USP) ..................... 664

Eleuthero (USP) .......................... 1588

Powdered Eleuthero (USP) .................... 1590

Powdered Eleuthero Extract (USP) ............... 1592

Entacapone (USP) ......................... 396

Pharmacopeial Forum

1816

INDEX Vol. 36(6) [Nov.–Dec. 2010]

Index

Entacapone Tablets (USP) .................... 667

Escitalopram Oxalate (USP) ................... 668

Escitalopram Tablets (USP) .................... 917

Estazolam (USP) .......................... 1527

Estazolam Tablets (USP) ..................... 1528

Estradiol and Norethindrone Acetate Tablets (USP erratum) 875

Estrone Injection (USP) ...................... 1529

Ethambutol Hydrochloride (USP) ................ 98

Ethylcellulose Dispersion Type B (NF) ............. 1635

Ethylparaben (NF) ......................... 1403

Ethynodiol Diacetate and Ethinyl Estradiol Tablets (USP) .. 1179

Etomidate (USP) .......................... 918

Etomidate Injection (USP) .................... 919

Fentanyl Transdermal System (USP) .............. 397

Fexofenadine Hydrochloride and Pseudoephedrine

Hydrochloride Extended-Release Tablets (USP erratum)

.. 642

Filgrastim (USP) .......................... 1180

Fish Oil Containing Omega-3 Acids Capsules (USP) ..... 152

Fish Oil Containing Omega-3 Acids Delayed-Release Capsules

(USP)

............................... 1594

Flecainide Acetate Oral Suspension (USP) ........... 401

Fluconazole Injection (USP) ................... 1530

Fludarabine Phosphate Injection (USP) ............. 402

Fluvastatin Sodium (USP) ..................... 921

Forskohlii (USP) .......................... 695

Powdered Forskohlii (USP) .................... 697

Powdered Forskohlii Extract (USP) ............... 698

Fosfomycin Tromethamine (USP) ................ 404

Gadodiamide Injection (USP) .................. 99

Galantamine Hydrobromide (USP) ............... 100

Ganciclovir (USP) ......................... 923

Garcinia cambogia (USP) ..................... 699

Powdered Garcinia cambogia (USP) .............. 701

Powdered Garcinia Hydroxycitrate Extract (USP) ....... 702

Garcinia indica (USP) ....................... 703

Powdered Garcinia indica (USP) ................. 704

Ginger (USP) ............................ 1595

Powdered Ginger (USP) ..................... 1597

Ginger Capsules (USP) ......................155, 1599

Ginger Tincture (USP) ....................... 1601

Ginkgo (USP) ............................ 1602

Powdered Ginkgo Extract (USP) ................. 1606

Ginkgo Capsules (USP) ...................... 1609

Ginkgo Tablets (USP) ....................... 1611

American Ginseng Capsules (USP) ............... 157

American Ginseng Tablets (USP) ................ 159

Asian Ginseng Tablets (USP) ................... 160

Anti-Human Globulin Serum (USP) ............... 1184

Glutathione (USP) ......................... 1221

Haloperidol Decanoate (USP erratum) ............. 1140

Heparin Calcium (USP) ...................... 1185

Heparin Calcium Injection (USP) ................ 1187

Histoplasmin (USP) ........................ 1188

Homatropine Methylbromide (USP) .............. 1188

Hydrochlorothiazide Capsules (USP) .............. 405

Hydrocortisone Acetate (USP) .................. 1533

Hydroxypropyl Corn Starch (NF) ................ 1229

Hydroxypropyl Pea Starch (NF) ................. 1230

Hydroxypropyl Potato Starch (NF) ............... 1232

Hypophosphorous Acid (NF) .................. 947

Indinavir Sulfate (USP) ...................... 406

Inﬂuenza Virus Vaccine (USP) .................. 1190

Insulin Aspart (USP) ........................ 1535

Insulin Aspart Subcutaneous Injection (USP) ......... 1537

Isophane Insulin Suspension (USP) ............... 1538

Isophane Insulin Human Suspension (USP) .......... 1539

Iodixanol Injection (USP) ..................... 103

Iohexol Injection (USP) ...................... 106

Irbesartan and Hydrochlorothiazide Tablets (USP) ......108, 409

Irinotecan Hydrochloride (USP erratum) ............ 1474

Ketoprofen Capsules (USP) .................... 1541

Ketoprofen Extended-Release Capsules (USP erratum) .... 1473

Lamotrigine Tablets (USP) ....................110, 1542

Lamotrigine Tablets for Oral Suspension (USP) ........ 1544

Lansoprazole (USP) ........................ 1547

Leﬂunomide Tablets (USP erratum) ............... 875

Letrozole (USP) .......................... 111

Letrozole Tablets (USP) ...................... 113

Leuprolide Acetate (USP) .....................49, 1145

Levalbuterol Hydrochloride (USP) ................ 670

Levetiracetam (USP) ........................ 1147

Levetiracetam Tablets (USP) ................... 115

Levocabastine Hydrochloride (USP) ............... 116

Levoﬂoxacin Oral Solution (USP) ................ 1548

Levonorgestrel and Ethinyl Estradiol Tablets (USP) ...... 117

Lidocaine (USP) .......................... 1191

Lidocaine Hydrochloride (USP) ................. 1191

Alpha Lipoic Acid Capsules (USP) ................ 145

Alpha Lipoic Acid Tablets (USP) ................. 146

Lopinavir (USP) .......................... 671

Loratadine Oral Solution (USP erratum) ............ 641

Loratadine Orally Disintegrating Tablets (USP) ........ 1550

Losartan Potassium Tablets (USP) ................ 411

Loxapine Succinate (USP) .................... 924

Lumefantrine (USP) ........................ 413

Lycopene Preparation (USP erratum) .............. 1473

Malabar-Nut-Tree, Leaf (USP) .................. 1614

Powdered Malabar-Nut-Tree, Leaf (USP) ............ 1615

Powdered Malabar-Nut-Tree, Leaf Extract (USP) ....... 1616

Maleic Acid (NF) .......................... 948

Measles Virus Vaccine Live (USP) ................ 1193

Measles, Mumps, and Rubella Virus Vaccine Live (USP) ... 1193

Measles and Rubella Virus Vaccine Live (USP) ......... 1193

Meﬂoquine Hydrochloride Tablets (USP) ............ 674

Mercaptopurine (USP) ...................... 1552

Mercaptopurine Tablets (USP) .................. 1554

meso-Zeaxanthin (USP) ...................... 1617

meso-Zeaxanthin Preparation (USP) .............. 1619

Methacrylic Acid Copolymer Dispersion (NF) ......... 1638

Methacrylic Acid and Ethyl Acrylate Copolymer Dispersion

(NF)

................................ 1640

Methotrexate (USP) ........................ 925

Methylene Blue Injection, Veterinary (USP erratum) ..... 879

Methylergonovine Maleate Injection (USP) .......... 929

Methylparaben (NF) ....................... 1404

Methylphenidate Hydrochloride (USP) ............. 119

Metronidazole Tablets (USP erratum) ............. 1473

Midodrine Hydrochloride (USP) ................. 414

Midodrine Hydrochloride Tablets (USP) ............ 415

Milbemycin Oxime (USP) .................... 417

Minocycline Hydrochloride (USP) ................ 418

Minocycline Hydrochloride (USP erratum) ........... 641

Minocycline Periodontal System (USP) ............. 420

Mirtazapine Orally Disintegrating Tablets (USP erratum) .. 35

Montelukast Sodium (USP) ................... 121

Morphine Sulfate Extended-Release Capsules (USP) ..... 422

Morphine Sulfate Extended-Release Tablets (USP) ...... 1556

Mumps Skin Test Antigen (USP) ................. 1194

Mumps Virus Vaccine Live (USP) ................ 1194

Mycophenolate Mofetil (USP erratum) ............. 1141

Nateglinide (USP erratum) .................... 1473

Diluted Nitroglycerin (USP) ................... 123

Norethindrone Acetate and Ethinyl Estradiol Tablets (USP) . 1195

Norgestimate and Ethinyl Estradiol Tablets (USP) ....... 1149

Nortriptyline Hydrochloride Capsules (USP erratum) .... 369

Nortriptyline Hydrochloride Oral Solution (USP erratum) .. 369

Octreotide Acetate (USP) ..................... 1559

Olanzapine and Fluoxetine Capsules (USP) .......... 423

Oleoyl Polyoxylglycerides (NF erratum) ............ 875

Olive Oil (NF erratum) ...................... 879

Olmesartan Medoxomil (USP) .................. 1197

Ondansetron Tablets (USP erratum) .............. 1474

Orbiﬂoxacin (USP erratum) ................... 35

Oseltamivir Phosphate (USP) .................. 124

Oseltamivir Phosphate Capsules (USP erratum) ........ 1473

Oxycodone Hydrochloride Extended-Release Tablets (USP) . 1199

Pentobarbital Oral Solution (USP) ................ 425

Pentobarbital Sodium Capsules (USP) ............. 426

Phenoxybenzamine Hydrochloride Capsules (USP) ......1202, 1562

Phyllanthus amarus (USP) ..................... 1620

Powdered Phyllanthus amarus Extract (USP) .......... 1622

Powdered Phyllanthus amarus (USP) .............. 1623

Pharmacopeial Forum

Vol. 36(6) [Nov.–Dec. 2010]

INDEX 1817

Index

Pioglitazone Hydrochloride (USP) ................ 126

Pioglitazone Tablets (USP) .................... 128

Piperazine Citrate (USP erratum) ................ 875

Platelet Concentrate (USP) .................... 1203

Platelets (USP) ........................... 1503

Poliovirus Vaccine Inactivated (USP) .............. 1204

Polyethylene Oxide (NF) ..................... 191

Polyglyceryl 3 Diisostearate (NF) ................ 451

Polyglyceryl Dioleate (NF) .................... 1234

Polyoxyl Lauryl Ether (NF) .................... 949

Polysorbate 20 (NF erratum) ..................876, 1473

Polysorbate 40 (NF erratum) .................. 876

Polysorbate 60 (NF erratum) .................. 877

Polyvinyl Acetate Dispersion (NF erratum) ........... 879

Polyvinyl Alcohol (USP erratum) ................. 37

Potassium Chloride Extended-Release Tablets (USP erratum) 641

Pramipexole Dihydrochloride (USP) .............. 676

Propafenone Hydrochloride (USP) ............... 129

Propofol (USP erratum) ...................... 1140

Propranolol Hydrochloride Extended-Release Capsules (USP) 33

Propylene Glycol Dicaprylate/Dicaprate (NF) ......... 1236

Propylparaben (NF) ........................ 1405

Protamine Sulfate (USP) .....................645, 1138

Protamine Sulfate Injection (USP) ................646, 1138

Protamine Sulfate for Injection (USP) ..............647, 1139

Protein Hydrolysate Injection (USP) ............... 1564

Pygeum Capsules (USP) ..................... 162

Rabies Vaccine (USP) ....................... 1204

Racemethionine (NF) ....................... 1236

Raloxifene Hydrochloride Tablets (USP) ............ 427

Repaglinide (USP) ......................... 428

Risedronate Sodium (USP) .................... 1150

Risperidone Orally Disintegrating Tablets (USP) ........ 1565

Ritonavir (USP erratum) ..................... 1141

Rivastigmine Tartrate Capsules (USP) .............. 131

Rizatriptan Benzoate (USP) .................... 132

Ropinirole Hydrochloride (USP) ................. 133

Ropinirole Tablets (USP) ..................... 678

Ropivacaine Hydrochloride (USP) ................ 135

Rubella Virus Vaccine Live (USP) ................. 1204

Saw Palmetto Capsules (USP) .................. 163

Scaffold Equine Pericardium Collagen (USP) ......... 1521

Scaffold Human Dermis (USP) .................. 680

Scaffold Human Peripheral Nerve (USP) ............ 1205

Scaffold Porcine Dermis (USP) .................. 1209

Scaffold Porcine Dermis Cross-Linked (USP) .......... 1212

Secobarbital Oral Solution (USP) ................ 430

Sertraline Hydrochloride (USP erratum) ............ 1473

Sertraline Tablets (USP) ...................... 138

Sevoﬂurane (USP) ......................... 139

Smallpox Vaccine (USP) ..................... 1214

Sodium Acetate (USP) ...................... 430

Bacteriostatic Sodium Chloride Injection (USP) ........ 431

Sodium Fluoride F18 Injection (USP erratum) ......... 1140

Sorbic Acid (NF) .......................... 951

Soy Isoﬂavones Capsules (USP) ................. 165

Soy Isoﬂavones Tablets (USP) .................. 167

Spironolactone (USP) ....................... 141

Stannous Chloride (NF erratum) ................ 875

Succinic Acid (NF) ......................... 453

Succinylcholine Chloride (USP erratum) ............ 35, 37

Sucrose Stearate (NF erratum) .................. 1474

Tacrolimus (USP) ......................... 1566

Tacrolimus Capsules (USP) .................... 1570

Telmisartan and Hydrochlorothiazide Tablets (USP) ..... 683

Temazepam (USP) ......................... 1574

Terazosin Capsules (USP) ..................... 685

Terazosin Tablets (USP) ...................... 687

Terbinaﬁne Tablets (USP) ..................... 142

Tetanus Toxoid (USP) ....................... 1214

Tetanus Toxoid Adsorbed (USP) ................. 1214

Tetanus and Diphtheria Toxoids Adsorbed for Adult Use

(USP)

............................... 1215

Tetracaine Hydrochloride for Injection (USP erratum) .... 641

Theophylline Oral Suspension (USP) .............. 432

Thrombin (USP) .......................... 1215

Tiagabine Hydrochloride Oral Suspension (USP erratum) .. 879

Ticlopidine Hydrochloride (USP erratum) ........... 1141

Topiramate (USP) ......................... 433

Topiramate Capsules (USP) ................... 930

Tramadol Hydrochloride Tablets (USP) ............. 1577

Tramadol Hydrochloride Extended-Release Tablets (USP) .. 1578

Trandolapril Tablets (USP) .................... 932

Triamcinolone Acetonide Injectable Suspension (USP) .... 1215

Triamcinolone Hexacetonide (USP) ............... 1216

Triamcinolone Hexacetonide Injectable Suspension (USP) . 1217

Trospium Chloride (USP) ..................... 933

Tuberculin (USP) .......................... 1218

Valacyclovir Tablets (USP) .................... 689

Valerian Tablets (USP) ....................... 169

Valganciclovir Hydrochloride (USP) ............... 935

Valsartan and Hydrochlorothiazide Tablets (USP erratum) . 1474

Valsartan and Hydrochlorothiazide Tablets (USP) ....... 1580

Vincristine Sulfate Injection (USP) ................883, 1469

Vincristine Sulfate for Injection (USP) ..............884, 1470

Vitamin A Tablets (USP) ...................... 1219

Oil-Soluble Vitamins Capsules (USP) .............. 169

Oil-Soluble Vitamins Tablets (USP) ............... 176

Oil- and Water-Soluble Vitamins with Minerals Capsules (USP

erratum)

.............................879, 1140

Oil- and Water-Soluble Vitamins with Minerals Tablets (USP

erratum)

............................. 879

Water for Injection (USP) ..................... 144

Yellow Fever Vaccine (USP) .................... 1220

Zaleplon (USP) ........................... 938

Zaleplon Capsules (USP) ..................... 939

Zein (NF) .............................. 1641

Ziprasidone Hydrochloride (USP erratum) ........... 1474

Zonisamide Capsules (USP) ................... 436

EXCIPIENTS

Excipients, USP and NF Excipients,

Listed by Category (NF)

....................183, 440, 1223, 1625

GENERAL CHAPTERS

Alternative Microbiological Sampling Methods for Nonsterile

Inhaled and Nasal Products h610i (USP)

........... 1667

Analysis of Biological Assays h1034i (USP) ........... 1005

Analytical Data—Interpretation and Treatment h1010i (USP) 483

Antibiotics—Microbial Assays h81i (USP) ........... 1239

Applications of Nuclear Magnetic Resonance Spectroscopy

h1761i (USP)

........................... 539

Articles of Botanical Origin h561i (USP) ............ 207

Articles of Botanical Origin h561i (USP erratum) ....... 641

Bacterial Endotoxins Test h85i (USP) .............. 1487

Biological Reactivity Tests, In Vivo h88i (USP) ......... 1664

Biotechnology-Derived Articles—Capillary Electrophoresis

h1053i (USP)

........................... 225

Bovine Serum h1024i (USP erratum) .............. 1141

Bulk Density and Tapped Density of Powders h616i (USP) . 1408

Bulk Powder Sampling Procedures h1097i (USP) ....... 760

Capillary Electrophoresis h727i (USP) ............. 218

Cell and Gene Therapy Products h1046i (USP) ........ 1289

Characterization of Crystalline and Partially Crystalline Solids

by X-ray Powder Diffraction (XRPD) h941i (USP erratum)

. 879

Density of Solids h699i (USP erratum) ............. 641

Design and Analysis of Biological Assays h111i (USP) .... 952

Development and Design of Bioassays h1032i (USP) .... 956

Disintegration and Dissolution of Dietary Supplements h2040i

(USP)

...............................567, 1384

Elemental Contaminants in Dietary Supplements h2232i

(USP)

............................... 258

Elemental Impurities—Limits h232i (USP) ........... 197

Elemental Impurities—Procedures h233i (USP) ........ 201

Emergency Medical Services Vehicles and Ambulances—

Storage of Preparations h1070i (USP)

............ 225

Flow Cytometry h1027i (USP) .................. 1266

Gene Therapy Products h1047 i (USP) ............. 1336

Globule Size Distribution in Lipid Injectable Emulsions h729i

(USP)

............................... 223

Glycoprotein and Glycan Analysis—General Considerations

h1084i (USP)

........................... 486

Pharmacopeial Forum

1818

INDEX Vol. 36(6) [Nov.–Dec. 2010]

Index

Good Storage and Shipping Practices h1079i (USP) ..... 226

Growth Factors and Cytokines Used in Cell Therapy

Manufacturing h92i (USP erratum)

.............. 1141

Identiﬁcation of Articles of Botanical Origin h563i (USP) .. 707

Immunological Test Methods: Enzyme-Linked

Immunosorbent Assay (ELISA) h1103i (USP)

........ 516

Immunological Test Methods—General Considerations

h1102i (USP)

........................... 502

Injections h1i (USP) ........................194, 1644

Medicine Dropper h1101i (USP) ................ 502

Microbial Identiﬁcation h1113i (USP) ............. 1675

Microbiological Evaluation of Clean Rooms and Other

Controlled Environments h1116i (USP)

........... 1688

Microbiological Examination of Nonsterile Products: Microbial

Enumeration Tests h61i (USP erratum)

............ 875

Near-Infrared Spectroscopy h1119i (USP) ........... 532

Nucleic Acid-Based Techniques—Microarray h1128i (USP) . 1713

Nuclear Magnetic Resonance Spectroscopy h761i (USP) .. 462

Osmolality and Osmolarity h785i (USP erratum) ....... 1140

Packaging and Storage Requirements h659i (USP) ......457, 1669

Pharmaceutical Compounding—Sterile Preparations h797i

(USP)

............................... 714

Pharmaceutical Dosage Forms h1151i (USP) ......... 1723

Products for Nebulization—Characterization Test h1601i

(USP)

............................... 534

Protein—Biological Adequacy Test h141i (USP) ........ 1666

Quality Assurance in Pharmaceutical Compounding h1163i

(USP)

............................... 247

Spectrophotometric Identiﬁcation Tests h197i (USP) .... 457

Sterility Tests h71i (USP erratum) ................ 875

Teaspoon h1221i (USP) ...................... 534

Thermal Analysis h891i (USP) .................. 289

Thermal Analysis h891i (USP erratum) ............. 37

Topical and Transdermal Products—Product Quality Tests h3i

(USP)

............................... 1647

USP Reference Standards h11 i (USP erratum) ......... 1141

Validation of Biological Assays h1033i (USP) ......... 986

Veriﬁcation of Compendial Procedures h1226i (USP) .... 1775

Viral Safety Evaluation of Biotechnology Products Derived

from Cell Lines of Human or Animal Origin h1050i (USP)

. 726

Water Determination h921i (USP) ............... 480

Water–Solid Interactions in Pharmaceutical Systems h1241i

(USP)

............................... 1063

Weights and Balances h41i (USP) ................ 454

REAGENTS, INDICATORS, AND SOLUTIONS

Chromatographic Columns

G## Octreotide Acetate, PTA-5 (USP)

............ 1778

L## Methotrexate, Resolvosil BSA (USP) .......... 1036

L## Octreotide Acetate, Synergi Max-RP (USP) ...... 1779

L17 (USP) ............................ 1779

L20 (USP) ............................ 1779

L34 (USP) ............................ 1779

L54 (USP erratum) ....................... 1140

L59 (USP) ............................ 1779

Reagent Speciﬁcations

Bis(4-sulfobutyl) Ether Disodium (USP)

........... 574

1,4-Butane Sultone (USP) ................... 574

Butyl Alcohol, Secondary (USP) ............... 781

Canola Oil (USP) ........................ 781

Cupric Acetate (USP) ...................... 574

Alpha-Cyclodextrin Hydrate (USP) .............. 574

Deuterium Chloride (USP) .................. 1392

Di(ethylene glycol) Methyl Ether (USP) ........... 781

Diethyl Sulfone (USP) ..................... 575

2-(Dimethylamino)ethyl Methacrylate (USP) ........ 1392

3,5-Dimethylphenol (USP erratum) ............. 1140

3,5-Dinitrobenzoyl Chloride (USP) .............. 1777

Dulcitol (USP) .......................... 1392

Epiandrosterone (USP) ..................... 781

Ether, Peroxide-Free (USP erratum) ............. 1140

Hexamethylenetetramine (USP) ............... 1392

Hydrobromic Acid (USP) ................... 267

4-Hydroxybutane-1-sulfonic Acid (USP) ........... 575

Lanthanum Nitrate Hexahydrate (USP) ........... 782

Metanil Yellow (USP) ...................... 267

Methenamine (USP) ...................... 1392

(R)-(+)-alpha-Methylbenzyl Isocyanate (USP) ....... 267

Methylene Blue (USP) ..................... 1036

Nitric Acid, Diluted (USP) ................... 1777

Nonoxynol-9 (USP) ...................... 267

Nonylparaben (USP) ...................... 575

Octanesulfonic Acid Sodium Salt (USP) ........... 1777

Perchloric Acid (USP) ..................... 1393

4-(2-Pyridylazo)resorcinol (USP) ............... 1393

Silica Gel (USP) ......................... 1036

Sodium 1-Octanesulfonate (USP) .............. 1777

Sodium 1-Pentanesulfonate (USP) .............. 268

Sodium 1-Pentanesulfonate, Anhydrous (USP) ....... 268

Sodium Bisulﬁte (USP) ..................... 782

Sodium Perchlorate (USP) ................... 1777

Sodium Phosphate, Dibasic, Heptahydrate (USP) ..... 1778

Sodium Pyrophosphate (USP) ................ 1778

Sulfamerazine (USP) ...................... 1393

Sunﬂower Oil (USP) ...................... 782

0.4 M Aqueous Tetrabutylammonium Hydroxide (USP) . 575

Triﬂuorovinyl Chloride Polymer (USP) ............ 1393

Test Solutions

Ammonium Carbonate TS2 (USP)

.............. 782

Methoxyphenylacetic TS (USP) ................ 782

Potassium Hydroxide TS2, Alcoholic (USP) ......... 782

Potassium Pyroantimonate TS (USP) ............ 783

Sodium Hydroxide TS3 (USP) ................ 783

Volumetric Solutions

Sodium Hydroxide, Normal (1 N) (USP)

.......... 1778

REFERENCE TABLES

Container Speciﬁcations (USP) .................269, 576, 784, 1037, 1394, 1780

Description and

Solubility (USP)

.........................271, 578, 786, 1039, 1396, 1782

Description and Solubility (USP erratum) ........... 1474

GENERAL SUBJECTS

Call for Candidates for 2010–2015 Council of Experts, Its

Expert Committees, and Its Expert Panels

..........20, 356, 628

Canceled Proposals ........................285, 595, 804, 1058, 1397, 1783

Comment Deadlines ....................... 1454

Cumulative Editions ........................21, 357, 630, 863, 1119, 1456

Errata List for USP 32–NF 27

Articles of Botanical Origin h561i (USP)

........... 641

Azithromycin for Injection (USP) ...............642, 1473

Bacitracin Ointment (USP) .................. 641

Benzalkonium Chloride Solution (USP) ........... 641

Capsicum Oleoresin (USP) .................. 1473

Cefaclor Capsules (USP) .................... 642

Cefazolin (USP) ......................... 641

Ceftazidime for Injection (USP) ................ 641

Cefuroxime Axetil for Oral Suspension (USP) ........ 875

Chlorhexidine Gluconate Solution (USP) .......... 35

Clindamycin Palmitate Hydrochloride for Oral Solution

(USP)

............................. 878

Cloprostenol Injection (USP) ................. 35

Cod Liver Oil (USP) ...................... 35

Density of Solids h699i (USP) ................. 641

Ecamsule Solution (USP) ................... 36

Estradiol and Norethindrone Acetate Tablets (USP) .... 875

Fexofenadine Hydrochloride and Pseudoephedrine

Hydrochloride Extended-Release Tablets (USP)

..... 642

Haloperidol Decanoate (USP) ................. 1140

Leﬂunomide Tablets (USP) .................. 875

Loratadine Oral Solution (USP) ................ 641

Lycopene Preparation (USP) ................. 1473

Metronidazole Tablets (USP) ................. 1473

Microbiological Examination of Nonsterile Products:

Microbial Enumeration Tests h61i (USP)

......... 875

Minocycline Hydrochloride (USP) .............. 641

Mirtazapine Orally Disintegrating Tablets (USP) ...... 35

Nortriptyline Hydrochloride Capsules (USP) ........ 369

Nortriptyline Hydrochloride Oral Solution (USP) ..... 369

Oleoyl Polyoxylglycerides (NF) ................ 875

Ondansetron Tablets (USP) .................. 1474

Orbiﬂoxacin (USP) ....................... 35

Pharmacopeial Forum

Vol. 36(6) [Nov.–Dec. 2010]

INDEX 1819

Index

Osmolality and Osmolarity h785i (USP) .......... 1140

Piperazine Citrate (USP) .................... 875

Polysorbate 20 (NF) ......................876, 1473

Polysorbate 40 (NF) ...................... 876

Polysorbate 60 (NF) ...................... 877

Potassium Chloride Extended-Release Tablets (USP) ... 641

Propofol (USP) ......................... 1140

Sodium Fluoride F18 Injection (USP) ............ 1140

Stannous Chloride (NF) .................... 875

Sterility Tests h71i (USP) .................... 875

Succinylcholine Chloride (USP) ................ 35

Tetracaine Hydrochloride for Injection (USP) ........ 641

Thermal Analysis h891i (USP) ................. 35

Errata List for USP 33–NF 28

Benzalkonium Chloride (USP)

................ 37

Bupropion Hydrochloride (USP) ............... 37

Cod Liver Oil (USP) ...................... 37

Ecamsule Solution (USP) ................... 37

Polyvinyl Alcohol (USP) .................... 37

Succinylcholine Chloride (USP) ................ 37

Thermal Analysis h891i (USP) ................. 37

Errata List for USP 33–NF 28 Reissue

Amiodarone Hydrochloride (USP)

.............. 1140

Bovine Serum h1024i (USP) ................. 1141

Cefdinir Capsules (USP) .................... 1474

Cetrizine Hydrochloride (USP) ................ 1474

Characterization of Crystalline and Partially Crystalline

Solids by X-ray Powder Diffraction (XRPD) h941i (USP)

879

Clarithromycin Tablets (USP) ................. 1141

Description and Solubility (USP) ............... 1474

3,5-Dimethylphenol (USP) .................. 1140

Ether, Peroxide-Free (USP) .................. 1140

Growth Factors and Cytokines Used in Cell Therapy

Manufacturing h92i (USP)

................. 1141

Irinotecan Hydrochloride (USP) ............... 1474

Ketoprofen Extended-Release Capsules (USP) ....... 1473

L54 (USP) ............................ 1140

Methylene Blue Injection, Veterinary (USP) ......... 879

Mycophenolate Mofetil (USP) ................ 1141

Nateglinide (USP) ....................... 1473

Oil- and Water-Soluble Vitamins with Minerals Capsules

(USP)

.............................879, 1140

Oil- and Water-Soluble Vitamins with Minerals Tablets

(USP)

............................. 879

Olive Oil (NF) .......................... 879

Ondansetron Tablets (USP) .................. 1474

Oseltamivir Phosphate Capsules (USP) ........... 1473

Polyvinyl Acetate Dispersion (NF) .............. 879

Ritonavir (USP) ......................... 1141

Sertraline Hydrochloride (USP) ................ 1473

Sucrose Stearate (NF) ..................... 1474

Tiagabine Hydrochloride Oral Suspension (USP) ..... 879

Ticlopidine Hydrochloride (USP) ............... 1141

USP General Notices and Requirements (USP) ....... 879

USP Reference Standards h11i (USP) ............ 1141

Valsartan and Hydrochlorothiazide Tablets (USP) ..... 1474

Ziprasidone Hydrochloride (USP) .............. 1474

Harmonization Introduction,

Stage 4

..............................287, 597, 805, 1059, 1399, 1785

Harmonization Introduction,

Stage 6

..............................293, 599, 807, 1061, 1401, 1787

Harmonization Stage 6

Bulk Density and Tapped Density of Powders h616i (USP)

1408

Ethylparaben (NF) ....................... 1403

Methylparaben (NF) ...................... 1404

Propylparaben (NF) ...................... 1405

Water–Solid Interactions in Pharmaceutical Systems h1241i

(USP)

............................. 1063

How to Use PF ...........................9, 345, 617, 849, 1105, 1441

Inactive Ingredients ........................363, 636, 869, 1126, 1463

IPR Introduction ..........................53, 373, 649, 887, 1153, 1493

IRA Introduction ..........................29, 365, 637, 871, 1127, 1465

The Journal of Standards Development and Ofﬁcial

Compendia Revision

......................4, 339, 611, 845, 1100, 1436

Nomenclature

Introduction

...........................331, 603, 835, 1081, 1425, 1807

Newly Approved United States Adopted Names (USAN),

Released for Publication

..................1083, 1809

Supplement 1, 2010 USP Dictionary ............ 1083

Supplement 2, 2010 USP Dictionary ............ 1809

Pending and Canceled Proposals ................1397, 1783

PF 36(6) is the Last Pharmacopeial Forum in Print Format;

Transitions to Online, Free Resource in January 2011

... 1454

Pharmacopeial Forum Public Review and Comment Period

Deadlines

.............................21, 356, 628, 862, 1118, 1455

Policies and Announcements

Call for Candidates for 2010–2015 Council of Experts, Its

Expert Committees, and Its Expert Panels

........20, 356, 628

Cumulative Editions ......................21, 357, 630, 863, 1119, 1456

Inactive Ingredients ......................363, 636, 869, 1126, 1463

Pending and Canceled Proposals ..............1397, 1783

PF 36(6) is the Last Pharmacopeial Forum in Print Format;

Transitions to Online, Free Resource in January 2011

. 1454

Pharmacopeial Forum Public Review and Comment Period

Deadlines

...........................21, 356, 628, 862, 1118, 1455

Priority New Monograph Items ...............22, 357, 630, 863, 1119, 1456

Two Monographs Proposed in this PF to Prospectively

Harmonize with PhEur

................... 20

Upcoming Changes to Pharmacopeial Forum ........628, 862, 1118

USP 33–NF 28 Recall and Reissue ..............628, 862, 1118, 1454

USP Posts Commentary to Interim Revision Announce-

ments on the USP Web Site

................20, 356, 628, 862, 1118, 1455

USP Proposes Changes to General Chapter h1i Injections 20

USP Proposes Changes to General Notices ......... 20

USP Proposes Revisions to Cephalexin Monographs Via

Interim Revision Announcement

............. 20

USP Proposes Three New Elemental Impurities General

Chapters

........................... 20

Previous PF Proposals Still

Pending

..............................272, 580, 788, 1041, 1397, 1783

Priority New Monograph Items .................22, 357, 630, 863, 1119, 1456

Proposed IRA Intro Section ....................39, 371, 643, 881, 1143, 1475

Standards Development .....................5, 341, 613, 845, 1101, 1437

Stimuli to the Revision Process

Introduction

...........................295, 601, 809, 1071, 1411, 1789

Determination of Organic Carbon Contamination in

Packaged Pharmaceutical Water—Contributions by the

Container

........................... 1414

Elemental Impurities—Comments and Responses ..... 306

Elemental Impurities—Information ............. 298

Flow Microscopy: Dynamic Image Analysis for Particle

Counting

........................... 311

Generalized Simpliﬁed Approaches for Mass Median

Aerodynamic Determination

................ 812

A Light-obscuration Method Speciﬁc for Quantifying Sub-

Visible Particles in Protein Therapeutics

......... 824

Ph. Eur. / USP Prospective Harmonization: API Pilot

Project—Industry Perspective

............... 1792

A Rapid Capillary Electrophoresis Method for the Detection

of Microbial Contamination: An Alternative Approach for

Sterility Testing

........................ 1798

A Recombinant Factor C Procedure for the Detection of

Gram-negative Bacterial Endotoxin

............ 321

Updating Sterile Packaged Water Attributes: Conductivity

and Total Organic Carbon

................. 1423

USP Responses to Comments on Stimuli Article: Acceptable,

Equivalent, or Better: Approaches for Alternatives to

Ofﬁcial Compendial Procedures

.............. 1077

USP Response to Stimuli Article European Pharmacopoeia–US

Pharmacopeia Prospective Harmonization: API Pilot

Project—Industry Perspective

............... 1797

USP Responses to Comments on Stimuli Article:

Performance-based Monographs

............. 1074

Two Monographs Proposed in This PF to Prospectively

Harmonize with PhEur

..................... 20

Upcoming Changes to Pharmacopeial Forum .........628, 862, 1118

USP 33–NF 28 Recall and Reissue ................628, 862, 1118, 1454

USP Posts Commentary to Interim Revision Announcements

on the USP Web Site

......................20, 356, 628, 862, 1118, 1455

USP Proposes Changes to General Chapter h1i Injections .. 20

USP Proposes Changes to General Notices .......... 20

Pharmacopeial Forum

1820

INDEX Vol. 36(6) [Nov.–Dec. 2010]

Index

USP Proposes Revisions to Cephalexin Monographs Via

Interim Revision Announcement

............... 20

USP Proposes Three New Elemental Impurities General

Chapters

............................. 20

Pharmacopeial Forum

Vol. 36(6) [Nov.–Dec. 2010]

INDEX 1821

Index

Table of Contents

IN-PROCESS REVISION

IPR Introduction

USP MONOGRAPH

Amiodarone Hydrochloride Oral Suspension [NEW] (USP35-NF30)

Amlodipine Oral Suspension [NEW] (USP35-NF30)

Beta Carotene Capsules (USP35-NF30)

Chloroquine Phosphate Oral Suspension [NEW] (USP35-NF30)

Codeine Phosphate Oral Solution [NEW] (USP35-NF30)

Dapsone Oral Suspension [NEW] (USP35-NF30)

Docetaxel Injection [NEW] (USP35-NF30)

Enalapril Maleate Oral Suspension [NEW] (USP35-NF30)

Enoxaparin Sodium (USP35-NF30)

Enoxaparin Sodium Injection (USP35-NF30)

Glycopyrrolate (USP35-NF30)

Glycopyrrolate Tablets (USP35-NF30)

Hydrochloric Acid Injection [NEW] (USP35-NF30)

Isradipine Oral Suspension [NEW] (USP35-NF30)

Lamotrigine Oral Suspension [NEW] (USP35-NF30)

Lisinopril Oral Suspension [NEW] (USP35-NF30)

Methyldopa (USP35-NF30)

Omeprazole Oral Suspension [NEW] (USP35-NF30)

Pentoxifylline Oral Suspension [NEW] (USP35-NF30)

Phenobarbital Oral Suspension [NEW] (USP35-NF30)

Primaquine Phosphate (USP35-NF30)

Primaquine Phosphate Tablets (USP35-NF30)

Propylthiouracil Oral Suspension [NEW] (USP35-NF30)

Pyrazinamide Oral Suspension [NEW] (USP35-NF30)

Pyrimethamine Oral Suspension [NEW] (USP35-NF30)

Rifabutin Oral Suspension [NEW] (USP35-NF30)

Rosiglitazone Maleate [NEW] (USP35-NF30)

Sildenafil Citrate Oral Suspension [NEW] (USP35-NF30)

Sodium Phenylbutyrate Oral Suspension [NEW] (USP35-NF30)

Sotalol Hydrochloride Oral Suspension [NEW] (USP35-NF30)

Spironolactone (USP35-NF30)

Spironolactone Oral Suspension [NEW] (USP35-NF30)

Spironolactone And Hydrochlorothiazide Oral Suspension [NEW] (USP35-NF30)

Tacrolimus Oral Suspension [NEW] (USP35-NF30)

Telmisartan (USP35-NF30)

Temozolomide [NEW] (USP35-NF30)

Temozolomide Oral Suspension [NEW] (USP35-NF30)

Tramadol Hydrochloride Oral Suspension [NEW] (USP35-NF30)

Tramadol Hydrochloride And Acetaminophen Oral Suspension [NEW] (USP35-NF30)

PF 37(1): Jan.-Feb. 2011 1

Trandolapril (USP35-NF30)

Ursodiol Oral Suspension [NEW] (USP35-NF30)

Valacyclovir Oral Suspension [NEW] (USP35-NF30)

Vincristine Sulfate (USP35-NF30)

Vincristine Sulfate Injection (USP35-NF30)

Vincristine Sulfate For Injection (USP35-NF30)

Vinorelbine Tartrate (USP35-NF30)

Vitamin E (USP35-NF30)

DIETARY SUPPLEMENT MONOGRAPH

Alpha Lipoic Acid (USP35-NF30)

NF MONOGRAPH

Lactobionic Acid (USP35-NF30)

Hydrogenated Starch Hydrolysate (USP35-NF30)

GENERAL CHAPTER

<17> Prescription Container Labeling [NEW] (USP35-NF30)

<401> Fats And Fixed Oils (USP35-NF30)

<467> Residual Solvents (USP35-NF30)

<781> Optical Rotation (USP35-NF30)

<823> Radiopharmaceuticals For Positron Emission Tomography-Compounding (USP35-NF30)

<1224> Transfer Of Analytical Procedures [NEW] (USP35-NF30)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Dibasic Potassium Phosphate Trihydrate [NEW] (USP35-NF30)

Sodium Phosphate, Tribasic (USP35-NF30)

Hydrochloric Acid, Half-Normal(0.5 N) (USP35-NF30)

L1 (USP35-NF30)

L23 (USP35-NF30)

REFERENCE TABLES

Description And Solubility (USP35-NF30)

Description And Solubility - R

Description And Solubility - T

STAGE 4 HARMONIZATION

Harmonization Introduction Stage 4

Gelatin, Gelling Grade

Gelatin, Non-Gelling Grade

PF 37(1): Jan.-Feb. 2011 2

STIMULI TO THE REVISION PROCESS

Stimuli Introduction

Bias Of The USP Harmonized Test For Dose Content Uniformity

Rationale For Revision Of USP General Chapter Radiopharmaceuticals For Positron Emission

Tomography-Compounding <823>

Revision Of USP General Chapter <671> Containers-Performance Testing

PF 37(1): Jan.-Feb. 2011 3

Table of Contents

Proposed IRA

Proposed IRA Intro Section

USP MONOGRAPHS

Modafinil

IN-PROCESS REVISION

IPR Introduction

USP MONOGRAPHS

Allantoin (USP35-NF30 1S)

Amiloxate (USP35-NF30 1S)

Epinephrine (USP35-NF30 1S)

Estradiol Vaginal Inserts (USP35-NF30 1S)

Eucalyptol (USP35-NF30 1S)

Eugenol (USP35-NF30 1S)

Haloperidol Injection (USP35-NF30 1S)

Haloperidol Oral Solution (USP35-NF30 1S)

Homosalate (USP35-NF30 1S)

Mirtazapine Orally Disintegrating Tablets (USP35-NF30 1S)

Montelukast Sodium (USP35-NF30 1S)

Piperacillin And Tazobactam For Injection (USP35-NF30 1S)

Triazolam (USP35-NF30 1S)

Verapamil Hydrochloride Extended-Release Capsules [NEW] (USP35-

NF30 1S)

NF MONOGRAPHS

Betadex Sulfobutyl Ether Sodium (USP35-NF30 1S)

PF 37(2): Mar.-Apr. 2011 1

GENERAL CHAPTERS

<31> Volumetric Apparatus (USP35-NF30 1S)

<181> Identification-Organic Nitrogenous Bases (USP35-NF30 1S)

<660> Containers-Glass (USP35-NF30 1S)

<1119> Near-Infrared Spectroscopy (USP35-NF30 1S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

2-Dimethylaminoethyl Methacrylate (USP35-NF30 1S)

Sodium Bitartrate (USP35-NF30 1S)

Sodium Borate (USP35-NF30 1S)

Uridine (USP35-NF30 1S)

Ammonium Sulfide TS (USP35-NF30 1S)

REFERENCE TABLES

Container Specifications For Capsules And Tablets - A

HARMONIZATION

Harmonization Introduction Stage 4

STIMULI TO THE REVISION PROCESS

Stimuli Introduction

Water For Analytical Purposes

PF 37(2): Mar.-Apr. 2011 2

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

USP MONOGRAPHS

Propofol Injectable Emulsion (USP35-NF30 1S)

Vinblastine Sulfate For Injection (USP35-NF30 1S)

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<232> Elemental Impurities--Limits

<233> Elemental Impurities--Procedures

<621> Chromatography

<698> Deliverable Volume

<731> Loss On Drying

<1105> Immunological Test Methods--Surface Plasmon Resonance

<1231> Water For Pharmaceutical Purposes

<1644> Theory And Practice Of Electrical Conductivity Measurements Of

Solutions

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

1-Hydroxybenzotriazole Hydrate

Pancreatic Digest Of Casein

Platinic Chloride

Chromatographic Columns

PF 37(3): May-Jun. 2011 1

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets

DESCRIPTION AND SOLUBILITY

Description And Solubility (USP35-NF30 1S)

Description And Solubility - F

Description And Solubility - O

Description And Solubility - Q

Description And Solubility - S

USP MONOGRAPHS

Articaine Hydrochloride And Epinephrine Injection [NEW] (USP35-NF30

1S)

Azithromycin For Injection (USP35-NF30 1S)

Bisacodyl (USP35-NF30 1S)

Carisoprodol (USP35-NF30 1S)

Carisoprodol Tablets (USP35-NF30 1S)

Cefamandole Nafate (USP35-NF30 1S)

Cefamandole Nafate For Injection (USP35-NF30 1S)

Cefpiramide (USP35-NF30 1S)

Cefpiramide For Injection (USP35-NF30 1S)

Ciclopirox Topical Solution [NEW] (USP35-NF30 1S)

Diphenhydramine Citrate And Ibuprofen Tablets [NEW] (USP35-NF30 1S)

Diphenhydramine Hydrochloride (USP35-NF30 1S)

Esomeprazole Magnesium Delayed-Release Capsules [NEW] (USP35-

NF30 1S)

Conjugated Estrogens (USP35-NF30 1S)

Esterified Estrogens (USP35-NF30 1S)

Esterified Estrogens Tablets (USP35-NF30 1S)

Ethinyl Estradiol (USP35-NF30 1S)

Famotidine (USP35-NF30 1S)

Famotidine Injection (USP35-NF30 1S)

Famotidine For Oral Suspension (USP35-NF30 1S)

Famotidine Tablets (USP35-NF30 1S)

PF 37(3): May-Jun. 2011 2

Felbamate [NEW] (USP35-NF30 1S)

Felbamate Oral Suspension [NEW] (USP35-NF30 1S)

Felbamate Tablets [NEW] (USP35-NF30 1S)

Itraconazole (USP35-NF30 1S)

Lactulose Solution (USP35-NF30 1S)

Leflunomide Tablets (USP35-NF30 1S)

Morphine Sulfate Injection (USP35-NF30 1S)

Omega-3 Acids Ethyl Esters Capsules [NEW]

Oxcarbazepine Oral Suspension [NEW] (USP35-NF30 1S)

Piperacillin For Injection (USP35-NF30 1S)

Quetiapine Fumarate [NEW] (USP35-NF30 1S)

Quinine Sulfate (USP35-NF30 1S)

Sildenafil Citrate [NEW] (USP35-NF30 1S)

Sincalide For Injection (USP35-NF30 1S)

Terbinafine Tablets (USP35-NF30 1S)

Valsartan Tablets [NEW] (USP35-NF30 1S)

STAGE 4 HARMONIZATION

Harmonization Introduction Stage 4

STIMULI TO THE REVISION PROCESS

Stimuli Introduction

USP Responses To Comments On Stimuli Article: Co-Processed Excipients

(USP35-NF30 1S)

PF 37(3): May-Jun. 2011 3

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<5> Inhalation And Nasal Drug Products - General Information And

Product Quality Tests [NEW] (USP35-NF30 2S)

<123> Glucagon Bioidentity Tests [NEW]

<601> Aerosols, Nasal Sprays, Metered-Dose Inhalers, And Dry Powder

Inhalers (USP35-NF30 2S)

<911> Newtonian Viscosity (USP35-NF30 2S)

<912> Rotational Rheometer Methods (USP35-NF30 2S)

<1079> Good Storage And Shipping Practices (USP35-NF30 2S)

<1102> Immunological Test Methods - General Considerations [NEW]

(USP35-NF30 2S)

<1150> Pharmaceutical Stability (USP35-NF30 2S)

<1238> Vaccines For Human Use - Bacterial Vaccines [NEW] (USP35-

NF30 2S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

D-10-Camphorsulfonic Acid [NEW] (USP35-NF30 2S)

Diatomaceous Earth, Flux-Calcinated (USP35-NF30 2S)

Diatomaceous Silica, Calcined (USP35-NF30 2S)

Dl-10-Camphorsulfonic Acid (USP35-NF30 2S)

Lead Acetate Cotton (USP35-NF30 2S)

Papaic Digest Of Soybean Meal (USP35-NF30 2S)

Peptic Digest Of Animal Tissue (USP35-NF30 2S)

PF 37(4): Jul.-Aug. 2011 1

Peptone, Dried (USP35-NF30 2S)

Tetrabutylammonium Hydrogen Sulfate Ion Pairing Reagent (USP35-

NF30 2S)

Tetrabutylammonium Hydroxide, 40 Percent In Water (USP35-NF30 2S)

Yeast Extract (USP35-NF30 2S)

Buffer Solutions (USP35-NF30 2S)

Hydrochloric Acid, Normal (1 N) (USP35-NF30 2S)

Hydrochloric Acid, Half-Normal (0.5 N) (USP35-NF30 2S)

Hydrochloric Acid, Half-Normal (0.5 N) In Methanol (USP35-NF30 2S)

Sulfuric Acid, Normal (1 N) (USP35-NF30 2S)

Chromatographic Columns

L8 (USP35-NF30 2S)

L10 (USP35-NF30 2S)

L43 (USP35-NF30 2S)

L72 (USP35-NF30 2S)

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets

Description And Solubility (USP35-NF30 2S)

Description And Solubility - A

Description And Solubility - D

Description And Solubility - E

Description And Solubility - P

Description And Solubility - S

Description And Solubility - V

DIETARY SUPPLEMENT MONOGRAPHS

Melatonin [NEW] (USP35-NF30 2S)

EXCIPIENTS

Briefing

Introduction

PF 37(4): Jul.-Aug. 2011 2

Emulsifying and/or Solubilizing Agent (USP35-NF30 2S)

Suspending and/or Viscosity-increasing Agent (USP35-NF30 2S)

Tablet Binder (USP35-NF30 2S)

Tablet and/or Capsule Diluent (USP35-NF30 2S)

Tablet Disintegrant (USP35-NF30 2S)

Wetting and/or Solubilizing Agent (USP35-NF30 2S)

NF MONOGRAPHS

Copovidone (USP35-NF30 2S)

Polyoxyl Stearate [NEW] (USP35-NF30 2S)

Polysorbate 20 (USP35-NF30 2S)

Polysorbate 40 (USP35-NF30 2S)

Polysorbate 60 (USP35-NF30 2S)

Pregelatinized Hydroxypropyl Corn Starch [NEW] (USP35-NF30 2S)

Pregelatinized Hydroxypropyl Pea Starch [NEW] (USP35-NF30 2S)

Pregelatinized Hydroxypropyl Potato Starch [NEW] (USP35-NF30 2S)

Xylitol (USP35-NF30 2S)

USP MONOGRAPHS

Amikacin (USP35-NF30 2S)

Amikacin Sulfate (USP35-NF30 2S)

Amikacin Sulfate Injection (USP35-NF30 2S)

Atracurium Besylate (USP35-NF30 2S)

Atracurium Besylate Injection (USP35-NF30 2S)

Clonidine Hydrochloride (USP35-NF30 2S)

Duloxetine Delayed-Release Capsules [NEW] (USP35-NF30 2S)

Duloxetine Hydrochloride [NEW] (USP35-NF30 2S)

Esmolol Hydrochloride [NEW] (USP35-NF30 2S)

Glucagon (USP35-NF30 2S)

Glucagon For Injection (USP35-NF30 2S)

Goserelin Acetate (USP35-NF30 2S)

Hydrocodone Bitartrate (USP35-NF30 2S)

Meclizine Hydrochloride (USP35-NF30 2S)

Menotropins (USP35-NF30 2S)

Menotropins For Injection (USP35-NF30 2S)

PF 37(4): Jul.-Aug. 2011 3

Metacresol (USP35-NF30 2S)

Niacin Extended-Release Tablets [NEW] (USP35-NF30 2S)

Nystatin Vaginal Inserts (USP35-NF30 2S)

Oxycodone Hydrochloride Tablets (USP35-NF30 2S)

Oxycodone And Acetaminophen Capsules (USP35-NF30 2S)

Oxycodone And Acetaminophen Tablets (USP35-NF30 2S)

Ritonavir (USP35-NF30 2S)

Sulfaquinoxaline (USP35-NF30 2S)

Valsartan And Hydrochlorothiazide Tablets (USP35-NF30 2S)

Voriconazole [NEW] (USP35-NF30 2S)

STAGE 4 HARMONIZATION

Harmonization Introduction Stage 4

STIMULI TO THE REVISION PROCESS

Stimuli Introduction

In Vitro Assessment Of Spacers And Valved Holding Chambers Used With

Pressurized Metered-Dose Inhalers: The Need For A USP Chapter With

Clinically Relevant Test Methods

PF 37(4): Jul.-Aug. 2011 4

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

USP MONOGRAPHS

Valacyclovir Hydrochloride (USP35-NF30 2S)

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<852> Atomic Absorption Spectroscopy [NEW] (USP35-NF30 2S)

<854> Mid-Infrared Spectroscopy [NEW] (USP35-NF30 2S)

<857> Ultraviolet-Visible Spectroscopy [NEW] (USP35-NF30 2S)

<913> Rolling Ball Viscometer Method [NEW] (USP35-NF30 2S)

<1088> In Vitro And In Vivo Evaluation Of Dosage Forms (USP35-NF30 2S)

<1103> Immunological Test Methods - Enzyme-Linked Immunosorbent Assay (Elisa) [NEW]

(USP35-NF30 2S)

<1724> Semisolid Drug Products - Performance Tests [NEW] (USP35-NF30 2S)

<1852> Atomic Absorption Spectroscopy - Theory And Practice [NEW] (USP35-NF30 2S)

<1854> Middle Infrared Spectroscopy - Theory And Practice [NEW] (USP35-NF30 2S)

<1857> Ultraviolet-Visible Spectroscopy - Theory And Practice [NEW] (USP35-NF30 2S)

REAGENTS, INDICATORS, AND SOLUTIONS

Edetate Disodium, Twentieth-Molar (0.05 M) (USP35-NF30 2S)

REFERENCE TABLES

CONTAINER SPECIFICATIONS

Containers for Dispensing Capsules and Tablets

DESCRIPTION AND SOLUBILITY

Description And Solubility (USP35-NF30 2S)

Description And Solubility - F

DIETARY SUPPLEMENT MONOGRAPHS

Beta Glucan [NEW] (USP35-NF30 2S)

Diosmin [NEW] (USP35-NF30 2S)

Krill Oil [NEW] (USP35-NF30 2S)

PF 37(5): Sep.-Oct. 2011 1

EXCIPIENTS

Briefing

Introduction

Color (USP35-NF30 2S)

NF MONOGRAPHS

Ferrosoferric Oxide [NEW] (USP35-NF30 2S)

Octoxynol 9 (USP35-NF30 2S)

USP MONOGRAPHS

Amoxapine (USP35-NF30 2S)

Atorvastatin Calcium Tablets [NEW] (USP35-NF30 2S)

Azeotropic Isopropyl Alcohol (USP35-NF30 2S)

Biotin (USP35-NF30 2S)

Clindamycin Phosphate (USP35-NF30 2S)

Clozapine (USP35-NF30 2S)

Cyanocobalamin (USP35-NF30 2S)

Drospirenone And Ethinyl Estradiol Tablets (USP35-NF30 2S)

Estradiol Cypionate (USP35-NF30 2S)

Estradiol Cypionate Injection (USP35-NF30 2S)

Fenofibrate Tablets [NEW] (USP35-NF30 2S)

Hydrocortisone (USP35-NF30 2S)

Hydrocortisone Acetate (USP35-NF30 2S)

Levetiracetam Oral Solution [NEW] (USP35-NF30 2S)

Methylbenzethonium Chloride (USP35-NF30 2S)

Omeprazole Delayed-Release Capsules (USP35-NF30 2S)

Ribavirin Tablets (USP35-NF30 2S)

Sumatriptan Injection [NEW] (USP35-NF30 2S)

STAGE 4 HARMONIZATION

Harmonization Introduction Stage 4

STIMULI TO THE REVISION PROCESS

Stimuli Introduction

PF 37(5): Sep.-Oct. 2011 2

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

USP MONOGRAPHS

Docetaxel (USP36-NF31)

Levalbuterol Hydrochloride (USP36-NF31)

Levalbuterol Inhalation Solution (USP36-NF31)

Mirtazapine Tablets (USP36-NF31)

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<1> Injections (USP36-NF31)

<681> Repackaging Into Single-Unit Containers And Unit-Dose Containers For Nonsterile Solid

And Liquid Dosage Forms (USP36-NF31)

<761> Nuclear Magnetic Resonance (USP36-NF31)

<788> Particulate Matter In Injections (USP36-NF31)

<1051> Cleaning Glass Apparatus (USP36-NF31)

<1136> Packaging-Unit-Of-Use (USP36-NF31)

<1146> Packaging Practice-Repackaging A Single Solid Oral Drug Product Into A Unit-Dose

Container (USP36-NF31)

<1197> Good Distribution Practices For Bulk Pharmaceutical Excipients [NEW] (USP36-NF31)

<1761> Applications Of Nuclear Magnetic Resonance Spectroscopy (USP36-NF31)

<2040> Disintegration And Dissolution Of Dietary Supplements (USP36-NF31)

REAGENTS, INDICATORS, AND SOLUTIONS

Chromatographic Columns

L-Isoleucine (USP36-NF31)

REFERENCE TABLES

CONTAINER SPECIFICATIONS

Containers for Dispensing Capsules and Tablets

DESCRIPTION AND SOLUBILITY

Description And Solubility (USP36-NF31)

Description And Solubility - C

Description And Solubility - D

PF 37(6): Nov.-Dec. 2011 1

Description And Solubility - E

Description And Solubility - G

Description And Solubility - R

DIETARY SUPPLEMENT MONOGRAPHS

Iron, Carbonyl [NEW] (USP36-NF31)

Melatonin Tablets [NEW] (USP36-NF31)

Pepper [NEW] (USP36-NF31)

Powdered Pepper [NEW] (USP36-NF31)

Powdered Pepper Extract [NEW] (USP36-NF31)

Spirulina [NEW] (USP36-NF31)

Spirulina Tablets [NEW] (USP36-NF31)

Oil-Soluble Vitamins Oral Solution [NEW] (USP36-NF31)

Oil-Soluble Vitamins With Minerals Capsules [NEW] (USP36-NF31)

Oil-Soluble Vitamins With Minerals Oral Solution [NEW] (USP36-NF31)

Oil-Soluble Vitamins With Minerals Tablets [NEW] (USP36-NF31)

EXCIPIENTS

USP AND NF EXCIPIENTS, LISTED BY CATEGORY

Briefing

Introduction

Emulsifying And/or Solubilizing Agent

Tablet And/or Capsule Lubricant

NF MONOGRAPHS

Glyceryl Tristearate [NEW] (USP36-NF31)

USP MONOGRAPHS

Abacavir Tablets (USP36-NF31)

Ammonium Alum (USP36-NF31)

Amodiaquine Hydrochloride Tablets (USP36-NF31)

Ciprofloxacin Extended-Release Tablets [NEW] (USP36-NF31)

Clarithromycin (USP36-NF31)

Clarithromycin For Oral Suspension (USP36-NF31)

Clarithromycin Extended-Release Tablets (USP36-NF31)

Doxycycline Tablets [NEW] (USP36-NF31)

Epoprostenol Sodium [NEW] (USP36-NF31)

Estradiol Injectable Suspension (USP36-NF31)

Levocarnitine Tablets (USP36-NF31)

Levofloxacin Tablets [NEW] (USP36-NF31)

Lopinavir (USP36-NF31)

Mirtazapine (USP36-NF31)

Mycophenolate Mofetil (USP36-NF31)

PF 37(6): Nov.-Dec. 2011 2

Olanzapine Tablets (USP36-NF31)

Potassium Iodide Oral Solution (USP36-NF31)

Potassium Iodide Tablets (USP36-NF31)

Potassium Iodide Delayed-Release Tablets (USP36-NF31)

Quinapril And Hydrochlorothiazide Tablets [NEW] (USP36-NF31)

Raloxifene Hydrochloride (USP36-NF31)

Raloxifene Hydrochloride Tablets (USP36-NF31)

Rufinamide [NEW] (USP36-NF31)

Rufinamide Tablets [NEW] (USP36-NF31)

Torsemide Tablets [NEW] (USP36-NF31)

STAGE 4 HARMONIZATION

Harmonization Introduction Stage 4

STIMULI TO THE REVISION PROCESS

Stimuli Introduction

Assays Using Test Kits: Applications In A Quality Control Environment

PF 37(6): Nov.-Dec. 2011 3

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<7> Labeling [NEW] (USP36-NF31)

<921> Water Determination (USP36-NF31)

<1094> Liquid-Filled Capsules - Dissolution Testing And Related Quality Attributes [NEW]

(USP36-NF31)

<1121> Nomenclature (USP36-NF31)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Beta-Cyclodextrin [NEW] (USP36-NF31)

5-Methoxy-1H-Benzimidazole-2-Thiol [NEW] (USP36-NF31)

Pentafluoropropionic Acid [NEW] (USP36-NF31)

REFERENCE TABLES

CONTAINER SPECIFICATIONS

Containers for Dispensing Capsules and Tablets

DESCRIPTION AND SOLUBILITY

Description And Solubility (USP36-NF31)

Description And Solubility - B

Description And Solubility - C

Description And Solubility - F

Description And Solubility - R

Description And Solubility - T

DIETARY SUPPLEMENT MONOGRAPHS

Gymnema [NEW] (USP36-NF31)

Native Gymnema Extract [NEW] (USP36-NF31)

Powdered Gymnema [NEW] (USP36-NF31)

Purified Gymnema Extract [NEW] (USP36-NF31)

PF 38(1): Jan.-Feb. 2012 1

EXCIPIENTS

USP AND NF EXCIPIENTS, LISTED BY CATEGORY

Briefing

Introduction

Emulsifying And/or Solubilizing Agent

NF MONOGRAPHS

Benzaldehyde (USP36-NF31)

Caprylic Acid [NEW] (USP36-NF31)

Caprylocaproyl Polyoxylglycerides (USP36-NF31)

Myristic Acid (USP36-NF31)

Oleic Acid (USP36-NF31)

USP MONOGRAPHS

Adenosine (USP36-NF31)

Adenosine Injection (USP36-NF31)

Alfuzosin Hydrochloride Extended-Release Tablets (USP36-NF31)

Amitriptyline Hydrochloride (USP36-NF31)

Amitriptyline Hydrochloride Injection (USP36-NF31)

Amlodipine And Benazepril Hydrochloride Capsules [NEW] (USP36-NF31)

Amoxapine Tablets (USP36-NF31)

Betaxolol Hydrochloride (USP36-NF31)

Bupropion Hydrochloride (USP36-NF31)

Calcium Pantothenate Tablets (USP36-NF31)

Clopidogrel Bisulfate (USP36-NF31)

Didanosine Delayed-Release Capsules [NEW] (USP36-NF31)

Escitalopram Oxalate (USP36-NF31)

Galantamine Hydrobromide (USP36-NF31)

Gentamicin Sulfate (USP36-NF31)

Hyaluronate Sodium [NEW] (USP36-NF31)

Ketorolac Tromethamine Tablets (USP36-NF31)

Levodopa (USP36-NF31)

Levodopa Capsules (USP36-NF31)

Levodopa Tablets (USP36-NF31)

Levothyroxine Sodium (USP36-NF31)

Lithium Oral Solution (USP36-NF31)

Mesoridazine Besylate (USP36-NF31)

Minoxidil Tablets (USP36-NF31)

Olanzapine (USP36-NF31)

Paricalcitol (USP36-NF31)

Sertraline Hydrochloride Oral Solution [NEW] (USP36-NF31)

Tadalafil [NEW] (USP36-NF31)

Tadalafil Tablets [NEW] (USP36-NF31)

Trospium Chloride (USP36-NF31)

Trospium Chloride Tablets [NEW] (USP36-NF31)

Vitamin E Capsules (USP36-NF31)

PF 38(1): Jan.-Feb. 2012 2

Vitamin E Preparation (USP36-NF31)

STAGE 4 HARMONIZATION

Harmonization Introduction Stage 4

STIMULI TO THE REVISION PROCESS

Stimuli Introduction

An Integrated And Harmonized Approach To Analytical Instrument Qualification And

Computerized System Validation - A Proposal For An Extension Of Analytical Instrument

Qualification <1058>

USP's Nomenclature Initiatives

Wavelengths Of Calibration Standards For Near-Infrared Diffuse Reflection Spectrometry

PF 38(1): Jan.-Feb. 2012 3

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

NF MONOGRAPHS

Benzalkonium Chloride

Benzalkonium Chloride Solution

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<87> Biological Reactivity Tests, In Vitro (USP36-NF31 1S)

<88> Biological Reactivity Tests, In Vivo (USP36-NF31 1S)

<208> Anti-Factor Xa And Anti-Factor IIa Assays For Unfractionated And Low Molecular Weight

Heparins [NEW] (USP36-NF31 1S)

<467> Residual Solvents (USP36-NF31 1S)

<621> Chromatography (USP36-NF31 1S)

<790> Visible Particulates In Injections [NEW] (USP36-NF31 1S)

<841> Specific Gravity (USP36-NF31 1S)

<1031> The Biocompatibility Of Materials Used In Drug Containers, Medical Devices, And Implants

(USP36-NF31 1S)

<1083> Good Distribution Practices - Supply Chain Integrity [NEW] (USP36-NF31 1S)

<1229> Sterilization Of Compendial Articles [NEW] (USP36-NF31 1S)

<1229.1> Steam Sterilization By Direct Contact [NEW] (USP36-NF31 1S)

<2021> Microbial Enumeration Tests - Nutritional And Dietary Supplements (USP36-NF31 1S)

<2023> Microbiological Attributes Of Nonsterile Nutritional And Dietary Supplements (USP36-NF31

1S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Peptone, Dried (USP36-NF31 1S)

L21 (USP36-NF31 1S)

S1D [NEW] (USP36-NF31 1S)

REFERENCE TABLES

CONTAINER SPECIFICATIONS

Containers for Dispensing Capsules and Tablets

PF 38(2): Mar.-Apr. 2012 1

DESCRIPTION AND SOLUBILITY

Description And Solubility (USP36-NF31 1S)

Description And Solubility - A

Description And Solubility - L

Description And Solubility - M

Description And Solubility - P

Description And Solubility - R

Description And Solubility - S

EXCIPIENTS

USP AND NF EXCIPIENTS, LISTED BY CATEGORY

Briefing

Introduction

Humectant

Solvent

Wetting and/or Solubilizing Agent

NF MONOGRAPHS

Dibutyl Sebacate (USP36-NF31 1S)

Maltitol (USP36-NF31 1S)

Methyl Salicylate (USP36-NF31 1S)

Propanediol [NEW] (USP36-NF31 1S)

USP MONOGRAPHS

Amoxicillin And Clavulanic Acid Extended-Release Tablets [NEW] (USP36-NF31 1S)

Aripiprazole [NEW] (USP36-NF31 1S)

Atomoxetine Hydrochloride [NEW] (USP36-NF31 1S)

Atomoxetine Capsules [NEW] (USP36-NF31 1S)

Atropine Sulfate Injection (USP36-NF31 1S)

Baclofen (USP36-NF31 1S)

Baclofen Tablets (USP36-NF31 1S)

Benzoyl Peroxide Lotion (USP36-NF31 1S)

Cefprozil (USP36-NF31 1S)

Clotrimazole Lozenges (USP36-NF31 1S)

Clotrimazole Topical Solution (USP36-NF31 1S)

Clotrimazole Vaginal Inserts (USP36-NF31 1S)

Cyclizine Hydrochloride (USP36-NF31 1S)

Cyclizine Hydrochloride Tablets (USP36-NF31 1S)

Dapsone (USP36-NF31 1S)

Dinoprostone (USP36-NF31 1S)

Diphenhydramine Hydrochloride (USP36-NF31 1S)

Estazolam (USP36-NF31 1S)

Fluconazole For Oral Suspension [NEW] (USP36-NF31 1S)

Gemfibrozil (USP36-NF31 1S)

Haloperidol (USP36-NF31 1S)

PF 38(2): Mar.-Apr. 2012 2

Irinotecan Hydrochloride Injection (USP36-NF31 1S)

Isopropyl Alcohol (USP36-NF31 1S)

Latanoprost [NEW] (USP36-NF31 1S)

Levetiracetam Tablets (USP36-NF31 1S)

Lopinavir And Ritonavir Tablets [NEW] (USP36-NF31 1S)

Lorazepam Oral Concentrate (USP36-NF31 1S)

Memantine Hydrochloride [NEW] (USP36-NF31 1S)

Mitotane (USP36-NF31 1S)

Oxaliplatin (USP36-NF31 1S)

Oxcarbazepine (USP36-NF31 1S)

Praziquantel (USP36-NF31 1S)

Rabeprazole Sodium [NEW] (USP36-NF31 1S)

Rabeprazole Sodium Delayed-Release Tablets [NEW] (USP36-NF31 1S)

Rocuronium Bromide (USP36-NF31 1S)

Salicylic Acid Plaster (USP36-NF31 1S)

Sulfasalazine Delayed-Release Tablets (USP36-NF31 1S)

Temazepam (USP36-NF31 1S)

Triacetin (USP36-NF31 1S)

STAGE 4 HARMONIZATION

Harmonization Introduction Stage 4

GENERAL CHAPTERS

<616> Bulk Density And Tapped Density Of Powders

NF MONOGRAPHS

Cellulose Acetate

STIMULI TO THE REVISION PROCESS

Stimuli Introduction

An Outline Of Planned Changes To USP <1211> Sterilization And Sterility Assurance Of Compendial

Articles

PF 38(2): Mar.-Apr. 2012 3

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

USP MONOGRAPHS

Glycopyrrolate

Heparin Sodium Injection

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<643> Total Organic Carbon (USP36-NF31 1S)

<645> Water Conductivity (USP36-NF31 1S)

<787> Subvisible Particulate Matter in Therapeutic Protein Injections [NEW] (USP36-NF31 1S)

<1106> Immunogenicity Assays - Design and Validation of Immunoassays To Detect Anti-Drug

Antibodies [NEW] (USP36-NF31 1S)

<1118> Monitoring Devices - Time, Temperature, and Humidity (USP36-NF31 1S)

<1229.2> Steam Sterilization of Aqueous Liquids [NEW] (USP36-NF31 1S)

<1231> Water for Pharmaceutical Purposes (USP36-NF31 1S)

<1724> Semisolid Drug Products - Performance Tests (USP36-NF31 1S)

<2232> Elemental Contaminants in Dietary Supplements (USP36-NF31 1S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Alizarin Complexone [NEW] (USP36-NF31 1S)

4-Amino-3-Hydroxy-1-Naphthalenesulfonic Acid (USP36-NF31 1S)

8-Amino-6-Methoxyquinoline (USP36-NF31 1S)

1,2,4-Aminonaphtholsulfonic Acid (USP36-NF31 1S)

Bacterial Alkaline Protease Preparation (USP36-NF31 1S)

Diatomaceous Earth, Flux-Calcined (USP36-NF31 1S)

1,1-Dichloro-2,2-Bis(P-Chlorophenyl)Ethane [NEW] (USP36-NF31 1S)

Ether, Peroxide-Free (USP36-NF31 1S)

Lanthanum Alizarin Complexan Mixture (USP36-NF31 1S)

Methyl Hexanoate [NEW] (USP36-NF31 1S)

Methyl Palmitoleate [NEW] (USP36-NF31 1S)

Pectate Lyase (USP36-NF31 1S)

Pepsin (USP36-NF31 1S)

Pepsin, Purified (USP36-NF31 1S)

Phosphomolybdic Acid (USP36-NF31 1S)

PF 38(3): May-Jun. 2012 1

Polyoxyethylene 10 Lauryl Ether [NEW] (USP36-NF31 1S)

Salicylic Acid [NEW] (USP36-NF31 1S)

Silica Gel, Octadecylsilanized Chromatographic (USP36-NF31 1S)

Sodium Bitartrate (USP36-NF31 1S)

Vinylpyrrolidinone (USP36-NF31 1S)

Test Solutions

Glucose Oxidase-Chromogen TS (USP36-NF31 1S)

Orthophenanthroline TS (USP36-NF31 1S)

Volumetric Solutions

Perchloric Acid, Tenth-Normal (0.1 N) in Glacial Acetic Acid (USP36-NF31 1S)

Chromatographic Columns

L45 (USP36-NF31 1S)

L48 (USP36-NF31 1S)

L66 (USP36-NF31 1S)

REFERENCE TABLES

CONTAINER SPECIFICATIONS

Containers for Dispensing Capsules and Tablets

DESCRIPTION AND SOLUBILITY

Description and Solubility

Description and Solubility - A

Description and Solubility - B

Description and Solubility - M

Description and Solubility - V

DIETARY SUPPLEMENT MONOGRAPHS

N-Acetyltyrosine (USP36-NF31 1S)

Valerian (USP36-NF31 1S)

Powdered Valerian (USP36-NF31 1S)

Powdered Valerian Extract (USP36-NF31 1S)

Valerian Tablets (USP36-NF31 1S)

EXCIPIENTS

USP AND NF EXCIPIENTS, LISTED BY CATEGORY

Briefing

Introduction

Emulsifying And/or Solubilizing Agent

Flavors and Perfumes

Plasticizer

Wetting And/or Solubilizing Agent

PF 38(3): May-Jun. 2012 2

NF MONOGRAPHS

Ammonium Glycyrrhizate [NEW] (USP36-NF31 1S)

Butane (USP36-NF31 1S)

Butyl Alcohol (USP36-NF31 1S)

Butyl Palmitostearate [NEW] (USP36-NF31 1S)

Butyl Stearate [NEW] (USP36-NF31 1S)

Cyclomethicone (USP36-NF31 1S)

Isobutane (USP36-NF31 1S)

Maltose (USP36-NF31 1S)

Potassium Benzoate (USP36-NF31 1S)

Propane (USP36-NF31 1S)

Sodium Benzoate (USP36-NF31 1S)

USP MONOGRAPHS

Acetaminophen (USP36-NF31 1S)

Amiloride Hydrochloride Tablets (USP36-NF31 1S)

Ampicillin (USP36-NF31 1S)

Anastrozole Tablets [NEW] (USP36-NF31 1S)

Antipyrine (USP36-NF31 1S)

Atropine Sulfate (USP36-NF31 1S)

Benzethonium Chloride Concentrate (USP36-NF31 1S)

Benzethonium Chloride Topical Solution (USP36-NF31 1S)

Calcium Acetate (USP36-NF31 1S)

Calcium Pantothenate (USP36-NF31 1S)

Dorzolamide Hydrochloride Ophthalmic Solution [NEW] (USP36-NF31 1S)

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution [NEW] (USP36-NF31 1S)

Estradiol Pellets (USP36-NF31 1S)

Ether (USP36-NF31 1S)

Hypromellose (USP36-NF31 1S)

Kanamycin Sulfate (USP36-NF31 1S)

Maprotiline Hydrochloride (USP36-NF31 1S)

Memantine Hydrochloride Tablets [NEW] (USP36-NF31 1S)

Meprobamate (USP36-NF31 1S)

Meprobamate Tablets (USP36-NF31 1S)

Metacresol (USP36-NF31 1S)

Methacholine Chloride (USP36-NF31 1S)

Methenamine Mandelate Delayed-Release Tablets (USP36-NF31 1S)

Mitomycin (USP36-NF31 1S)

Mitomycin for Injection (USP36-NF31 1S)

Moexipril Hydrochloride [NEW] (USP36-NF31 1S)

Nicardipine Hydrochloride [NEW] (USP36-NF31 1S)

Nortriptyline Hydrochloride (USP36-NF31 1S)

Omeprazole (USP36-NF31 1S)

Phenytoin Sodium Injection (USP36-NF31 1S)

Povidone (USP36-NF31 1S)

Prilocaine Hydrochloride (USP36-NF31 1S)

Quinine Sulfate Capsules (USP36-NF31 1S)

PF 38(3): May-Jun. 2012 3

Quinine Sulfate Tablets (USP36-NF31 1S)

Ribavirin Capsules [NEW] (USP36-NF31 1S)

Thioridazine Hydrochloride Tablets (USP36-NF31 1S)

Valproate Sodium Injection (USP36-NF31 1S)

Valproic Acid (USP36-NF31 1S)

Valproic Acid Capsules (USP36-NF31 1S)

Valproic Acid Oral Solution (USP36-NF31 1S)

Vigabatrin [NEW] (USP36-NF31 1S)

Sterile Purified Water (USP36-NF31 1S)

Sterile Water for Inhalation (USP36-NF31 1S)

Sterile Water for Injection (USP36-NF31 1S)

Sterile Water for Irrigation (USP36-NF31 1S)

STAGE 4 HARMONIZATION

Harmonization Introduction Stage 4

STIMULI TO THE REVISION PROCESS

Stimuli Introduction

Products From Natural Origin for Health Purposes: Transitioning From Dietary Supplements To

Dietary Supplements and Traditional Medicines

Signal-To-Noise Measurements From Chromatographic Data

PF 38(3): May-Jun. 2012 4

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

USP MONOGRAPHS

Colloidal Oatmeal

Simethicone Emulsion

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<2> Oral Drug Products-Product Quality Tests [NEW] (USP36-NF31 2S)

<561> Articles of Botanical Origin (USP36-NF31 2S)

<698> Deliverable Volume (USP36-NF31 2S)

<1030> Biological Assay Chapters-Overview and Glossary [NEW] (USP36-NF31 2S)

<1087> Apparent Intrinsic Dissolution-Dissolution Testing Procedures for Rotating Disk and

Stationary Disk (USP36-NF31 2S)

<1104> Immunological Test Methods-Immunoblot Analysis [NEW] (USP36-NF31 2S)

<1229.3> Monitoring of Bioburden [NEW] (USP36-NF31 2S)

<1660> Evaluation of The Inner Surface Durability of Glass Containers [NEW] (USP36-NF31 2S)

REAGENTS, INDICATORS AND SOLUTIONS

Reagents, Indicators, and Solutions

Reagent Specifications

Reagents

Reagent Specifications

Gadolinium Sulfate [NEW] (USP36-NF31 2S)

Nitric Acid, Diluted (USP36-NF31 2S)

Octanesulfonic Acid Sodium Salt (USP36-NF31 2S)

Sodium Hypochlorite Solution (USP36-NF31 2S)

Indicators

Indicators (USP36-NF31 2S)

Indicators and Test Papers

Indicator and Test Papers (USP36-NF31 2S)

Buffer Solutions

PF 38(4): Jul.-Aug. 2012 1

Buffer Solutions (USP36-NF31 2S)

Colorimetric Solutions

Colorimetric Solutions (Cs) (USP36-NF31 2S)

Test Solutions

Test Solutions (USP36-NF31 2S)

Volumetric Solutions

Volumetric Solutions (USP36-NF31 2S)

Sodium Thiosulfate, Tenth-Normal (0.1 N) (USP36-NF31 2S)

Chromatographic Columns

L## (Methacholine Chloride, Ionpac Cs17) [NEW] (USP36-NF31 2S)

L76 [NEW] (USP36-NF31 2S)

CONTAINER SPECIFICATIONS

Containers for Dispensing Capsules and Tablets (USP36-NF31 2S)

DESCRIPTION AND SOLUBILITY

Description and Solubility (USP36-NF31 2S)

Description and Solubility - A (USP36-NF31 2S)

Description and Solubility - P (USP36-NF31 2S)

DIETARY SUPPLEMENT MONOGRAPHS

Chinese Salvia [NEW] (USP36-NF31 2S)

Powdered Chinese Salvia [NEW] (USP36-NF31 2S)

Valerian Tincture [NEW] (USP36-NF31 2S)

EXCIPIENTS

USP AND NF EXCIPIENTS, LISTED BY CATEGORY

Briefing

Introduction

Flavors and Perfumes (USP36-NF31 2S)

Wetting and/or Solubilizing Agent (USP36-NF31 2S)

NF MONOGRAPHS

Isobutyl Alcohol [NEW] (USP36-NF31 2S)

USP MONOGRAPHS

Acyclovir (USP36-NF31 2S)

Albuterol Extended-Release Tablets [NEW] (USP36-NF31 2S)

Aminobenzoic Acid (USP36-NF31 2S)

PF 38(4): Jul.-Aug. 2012 2

Bethanechol Chloride (USP36-NF31 2S)

Bethanechol Chloride Injection (USP36-NF31 2S)

Bethanechol Chloride Tablets (USP36-NF31 2S)

Butalbital (USP36-NF31 2S)

Capsicum (USP36-NF31 2S)

Capsicum Oleoresin (USP36-NF31 2S)

Carbidopa and Levodopa Orally Disintegrating Tablets [NEW] (USP36-NF31 2S)

Urea C 13 (USP36-NF31 2S)

Cefuroxime Axetil (USP36-NF31 2S)

Cefuroxime Axetil Tablets (USP36-NF31 2S)

Chloroquine Phosphate (USP36-NF31 2S)

Cholecalciferol Capsules [NEW] (USP36-NF31 2S)

Cyclobenzaprine Hydrochloride (USP36-NF31 2S)

Cyclosporine (USP36-NF31 2S)

Cyproheptadine Hydrochloride (USP36-NF31 2S)

Diphenhydramine Citrate (USP36-NF31 2S)

Halobetasol Propionate (USP36-NF31 2S)

Lamivudine Oral Solution [NEW] (USP36-NF31 2S)

Levetiracetam Extended-Release Tablets [NEW] (USP36-NF31 2S)

Lopinavir and Ritonavir Oral Solution [NEW] (USP36-NF31 2S)

Metolazone (USP36-NF31 2S)

Moexipril Hydrochloride Tablets [NEW] (USP36-NF31 2S)

Moexipril Hydrochloride and Hydrochlorothiazide Tablets [NEW] (USP36-NF31 2S)

Nifedipine (USP36-NF31 2S)

Oxazepam (USP36-NF31 2S)

Oxybutynin Chloride (USP36-NF31 2S)

Pancuronium Bromide (USP36-NF31 2S)

Pancuronium Bromide Injection [NEW] (USP36-NF31 2S)

Paricalcitol Injection (USP36-NF31 2S)

Rivastigmine [NEW] (USP36-NF31 2S)

Sipuleucel-T [NEW] (USP36-NF31 2S)

Zinc Acetate Oral Solution [NEW] (USP36-NF31 2S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS

Stimuli To The Revision Process

Revision of USP General Chapter Deliverable Volume <698>

Revision of General Chapter Radioactivity <821>

Solubility Criteria for Veterinary Drugs

PF 38(4): Jul.-Aug. 2012 3

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

USP MONOGRAPHS

Heparin Lock Flush Solution

Sevoflurane

Tramadol Hydrochloride

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<16> Automated Methods of Analysis (USP36-NF31 2S)

<41> Weights and Balances (USP36-NF31 2S)

<401> Fats and Fixed Oils (USP36-NF31 2S)

<735> X-Ray Fluorescence Spectrometry [NEW] (USP36-NF31 2S)

<1059> Excipient Performance (USP36-NF31 2S)

<1251> Weighing On An Analytical Balance (USP36-NF31 2S)

<1788> Methods for The Determination of Particulate Matter in Injections and Ophthalmic

Solutions (USP36-NF31 2S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Salicylaldazine (USP36-NF31 2S)

Salicylaldehyde (USP36-NF31 2S)

Succinic Acid (USP36-NF31 2S)

Chromatographic Columns

L## [NEW] (USP36-NF31 2S)

CONTAINER SPECIFICATIONS

Containers for Dispensing Capsules and Tablets (USP36-NF31 2S)

DESCRIPTION AND SOLUBILITY

Description and Solubility (USP36-NF31 2S)

Description and Solubility - A

Description and Solubility - B

Description and Solubility - C

Description and Solubility - D

PF 38(5): Sep.-Oct. 2012 1

Description and Solubility - E

Description and Solubility - F

Description and Solubility - G

Description and Solubility - H

Description and Solubility - I

Description and Solubility - J

Description and Solubility - K

Description and Solubility - L

Description and Solubility - M

Description and Solubility - N

Description and Solubility - O

Description and Solubility - P

Description and Solubility - Q

Description and Solubility - R

Description and Solubility - S

Description and Solubility - T

Description and Solubility - U

Description and Solubility - V

Description and Solubility - W

Description and Solubility - X

Description and Solubility - Y

Description and Solubility - Z

DIETARY SUPPLEMENT MONOGRAPHS

Astaxanthin Esters [NEW] (USP36-NF31 2S)

Calcium L-5-Methyltetrahydrofolate [NEW] (USP36-NF31 2S)

Lutein Capsules [NEW] (USP36-NF31 2S)

Minerals Capsules (USP36-NF31 2S)

Minerals Tablets (USP36-NF31 2S)

Oil- and Water-Soluble Vitamins Capsules (USP36-NF31 2S)

Oil- and Water-Soluble Vitamins Oral Solution (USP36-NF31 2S)

Oil- and Water-Soluble Vitamins Tablets (USP36-NF31 2S)

Oil- and Water-Soluble Vitamins With Minerals Capsules (USP36-NF31 2S)

Oil- and Water-Soluble Vitamins With Minerals Oral Solution (USP36-NF31 2S)

Oil- and Water-Soluble Vitamins With Minerals Tablets (USP36-NF31 2S)

Water-Soluble Vitamins Capsules (USP36-NF31 2S)

Water-Soluble Vitamins Tablets (USP36-NF31 2S)

Water-Soluble Vitamins With Minerals Capsules (USP36-NF31 2S)

Water-Soluble Vitamins With Minerals Oral Solution (USP36-NF31 2S)

Water-Soluble Vitamins With Minerals Tablets (USP36-NF31 2S)

EXCIPIENTS

USP AND NF EXCIPIENTS, LISTED BY CATEGORY

Briefing (USP36-NF31 2S)

Adhesive

Air Displacement

PF 38(5): Sep.-Oct. 2012 2

Alcohol Denaturant

Antifoaming Agent

Antimicrobial Preservative

Antioxidant

Bulking Agent

Capsule Shell

Carrier

Chelating and/or Complexing Agents

Coating Agent

Colloid Stabilizing Agent

Coloring Agent

Desiccant

Diluent

Disintegrant

Emollient

Emulsifying Agent

Film-Forming Agent

Filtering Aid

Flavors and Frangrance

Free Radical Scavenger

Glidant and/or Anticaking Agent

Humectant

Lubricant

Ointment Base

Pharmaceutical Water

Ph Modifier (Acidifying Agent/ Alkalizing Agent/ Buffering Agent)

Plasticizer

Polymers for Ophthalmic Use

Polymer Membrane

Propellant

Reducing Agent

Release-Modifying Agents

Sequestering Agent

Solvent

Sorbent

Sorbent, Carbon Dioxide

Stiffening Agent

Suppository Base

Suspending and/or Viscosity-Increasing Agent

Sweetening Agent

Tonicity Agent

Transfer Ligand

Vehicle

Water-Repelling Agent

Wet Binder

Wetting and/or Solubilizing Agent

PF 38(5): Sep.-Oct. 2012 3

NF MONOGRAPHS

Methylpyrrolidone (USP36-NF31 2S)

Sucrose Octaacetate (USP36-NF31 2S)

USP MONOGRAPHS

Ampicillin Capsules (USP36-NF31 2S)

Ampicillin Tablets (USP36-NF31 2S)

Avobenzone (USP36-NF31 2S)

Azelastine Hydrochloride [NEW] (USP36-NF31 2S)

Bacampicillin Hydrochloride (USP36-NF31 2S)

Bacampicillin Hydrochloride for Oral Suspension (USP36-NF31 2S)

Bacampicillin Hydrochloride Tablets (USP36-NF31 2S)

Biotin Capsules [NEW] (USP36-NF31 2S)

Biotin Tablets [NEW] (USP36-NF31 2S)

Cephalexin (USP36-NF31 2S)

Cephalexin Capsules (USP36-NF31 2S)

Cephalexin for Oral Suspension (USP36-NF31 2S)

Erythromycin Ethylsuccinate Tablets (USP36-NF31 2S)

Flunixin Meglumine Injection (USP36-NF31 2S)

Fluticasone Propionate Inhalation Aerosol [NEW] (USP36-NF31 2S)

Fluticasone Propionate Inhalation Powder [NEW] (USP36-NF31 2S)

Gadopentetate Dimeglumine Injection (USP36-NF31 2S)

Gemcitabine Hydrochloride (USP36-NF31 2S)

Gemcitabine for Injection (USP36-NF31 2S)

Glyburide Tablets (USP36-NF31 2S)

Leucovorin Calcium Tablets (USP36-NF31 2S)

Lomustine [NEW] (USP36-NF31 2S)

Lomustine Capsules [NEW] (USP36-NF31 2S)

Loratadine (USP36-NF31 2S)

Methylphenidate Hydrochloride (USP36-NF31 2S)

Mezlocillin Sodium (USP36-NF31 2S)

Moxidectin [NEW] (USP36-NF31 2S)

Octinoxate (USP36-NF31 2S)

Orphenadrine Citrate, Aspirin, and Caffeine Tablets [NEW] (USP36-NF31 2S)

Oxcarbazepine Tablets (USP36-NF31 2S)

Pioglitazone and Glimepiride Tablets [NEW] (USP36-NF31 2S)

Pioglitazone and Metformin Hydrochloride Tablets [NEW] (USP36-NF31 2S)

Polymyxin B Sulfate (USP36-NF31 2S)

Pseudoephedrine Sulfate (USP36-NF31 2S)

Quetiapine Tablets [NEW] (USP36-NF31 2S)

Risperidone Oral Solution (USP36-NF31 2S)

Ritonavir Capsules [NEW] (USP36-NF31 2S)

Ritonavir Oral Solution [NEW] (USP36-NF31 2S)

Ritonavir Tablets [NEW] (USP36-NF31 2S)

Sulfacetamide (USP36-NF31 2S)

Sulfacetamide Sodium (USP36-NF31 2S)

Troleandomycin (USP36-NF31 2S)

PF 38(5): Sep.-Oct. 2012 4

Troleandomycin Capsules (USP36-NF31 2S)

Zolpidem Tartrate Tablets (USP36-NF31 2S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

USP MONOGRAPHS

Petrolatum (USP36-NF31 2S)

White Petrolatum (USP36-NF31 2S)

STIMULI TO THE REVISION PROCESS

Stimuli To The Revision Process

PF 38(5): Sep.-Oct. 2012 5

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

USP MONOGRAPHS

Citalopram Oral Solution

Citalopram Tablets

Escitalopram Tablets

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<1> Injections and Implanted Drug Products (Parenterals)-Product Quality Tests (USP37-NF32)

<7> Labeling (USP37-NF32)

<268> Porosity by Nitrogen Adsorption-Desorption [NEW] (USP37-NF32)

<571> Vitamin A Assay (USP37-NF32)

<581> Vitamin D Assay (USP37-NF32)

<645> Water Conductivity (USP37-NF32)

<659> Packaging and Storage Requirements (USP37-NF32)

<697> Container Content for Injections [NEW] (USP37-NF32)

<790> Visible Particulates in Injections [NEW] (USP37-NF32)

<1121> Nomenclature (USP37-NF32)

<1197> Good Distribution Practices for Bulk Pharmaceutical Excipients (USP37-NF32)

<1911> Rheometry [NEW] (USP37-NF32)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Amyl Acetate (USP37-NF32)

Ferrous Chloride Tetrahydrate [NEW] (USP37-NF32)

Silicotungstic Acid, N-Hydrate (USP37-NF32)

Sulfanilamide (USP37-NF32)

O-Tolidine (USP37-NF32)

Volumetric Solutions

Perchloric Acid, Tenth-Normal (0.1 N) in Glacial Acetic Acid (USP37-NF32)

Potassium Hydroxide, Normal (1 N) (USP37-NF32)

Sodium Nitrite, Tenth-Molar (0.1 M) (USP37-NF32)

Chromatographic Columns

PF 38(6): Nov.-Dec. 2012 1

L## (Adenine, Acclaim Mixed-Mode Wcx-1 [NEW] (USP37-NF32)

CONTAINER SPECIFICATIONS

Containers for Dispensing Capsules and Tablets (USP37-NF32)

DESCRIPTION AND SOLUBILITY

Description and Solubility [NEW] (USP37-NF32)

Description and Solubility - D

Description and Solubility - L

Description and Solubility - M

Description and Solubility - R

Description and Solubility - T

Description and Solubility - Z

DIETARY SUPPLEMENT MONOGRAPHS

N-Acetylglucosamine [NEW] (USP37-NF32)

Capsicum Tincture [NEW] (USP37-NF32)

Echinacea Angustifolia (USP37-NF32)

Powdered Echinacea Angustifolia (USP37-NF32)

Powdered Echinacea Angustifolia Extract (USP37-NF32)

Echinacea Pallida (USP37-NF32)

Powdered Echinacea Pallida (USP37-NF32)

Powdered Echinacea Pallida Extract (USP37-NF32)

Echinacea Purpurea Aerial Parts (USP37-NF32)

Echinacea Purpurea Root (USP37-NF32)

Powdered Echinacea Purpurea (USP37-NF32)

Powdered Echinacea Purpurea Extract (USP37-NF32)

Holy Basil [NEW] (USP37-NF32)

Powdered Holy Basil [NEW] (USP37-NF32)

Powdered Holy Basil Extract [NEW] (USP37-NF32)

Rutin [NEW] (USP37-NF32)

EXCIPIENTS

USP AND NF EXCIPIENTS, LISTED BY CATEGORY

Briefing

Introduction

Antifoaming Agent

Antimicrobial Preservative

Emulsifying and/or Solubilizing Agent

Tablet and/or Capsule Lubricant

NF MONOGRAPHS

Ascorbyl Palmitate (USP37-NF32)

Behenoyl Polyoxylglycerides (USP37-NF32)

Lauric Acid [NEW] (USP37-NF32)

PF 38(6): Nov.-Dec. 2012 2

Lauroyl Polyoxylglycerides (USP37-NF32)

Lecithin (USP37-NF32)

Linoleoyl Polyoxylglycerides (USP37-NF32)

Oleoyl Polyoxylglycerides (USP37-NF32)

Squalane (USP37-NF32)

Stearoyl Polyoxylglycerides (USP37-NF32)

Sugar Spheres (USP37-NF32)

Compressible Sugar (USP37-NF32)

Confectioner's Sugar (USP37-NF32)

USP MONOGRAPHS

Adenine (USP37-NF32)

Adenosine (USP37-NF32)

Alfuzosin Hydrochloride (USP37-NF32)

Aloe (USP37-NF32)

Anastrozole (USP37-NF32)

Artemether [NEW] (USP37-NF32)

Aspirin, Alumina, and Magnesium Oxide Tablets (USP37-NF32)

Atovaquone (USP37-NF32)

Bovine Acellular Dermal Matrix (USP37-NF32)

Brompheniramine Maleate (USP37-NF32)

Chloroxylenol (USP37-NF32)

Chlorpheniramine Maleate (USP37-NF32)

Chondroitin Sulfate Sodium (USP37-NF32)

Chondroitin Sulfate Sodium, Shark [NEW] (USP37-NF32)

Codeine Phosphate (USP37-NF32)

Codeine Sulfate Oral Solution [NEW] (USP37-NF32)

Cyanocobalamin Tablets [NEW] (USP37-NF32)

Dexbrompheniramine Maleate (USP37-NF32)

Dexchlorpheniramine Maleate (USP37-NF32)

Dexmedetomidine Hydrochloride [NEW] (USP37-NF32)

Dioxybenzone (USP37-NF32)

Doxycycline Extended-Release Capsules [NEW] (USP37-NF32)

Epoprostenol for Injection [NEW] (USP37-NF32)

Fentanyl Transdermal System [NEW] (USP37-NF32)

Flutamide (USP37-NF32)

Heparin Lock Flush Solution (USP37-NF32)

Heparin Sodium (USP37-NF32)

Heparin Sodium Injection (USP37-NF32)

Lamivudine and Zidovudine Tablets (USP37-NF32)

Loratadine Chewable Tablets [NEW] (USP37-NF32)

Mandelic Acid [NEW] (USP37-NF32)

Menthol (USP37-NF32)

Mepivacaine Hydrochloride (USP37-NF32)

Meropenem for Injection (USP37-NF32)

Naproxen Sodium and Pseudoephedrine Hydrochloride Extended-Release Tablets [NEW] (USP37-

PF 38(6): Nov.-Dec. 2012 3

NF32)

Olanzapine and Fluoxetine Capsules (USP37-NF32)

Oxybenzone (USP37-NF32)

Penicillin G Potassium Tablets (USP37-NF32)

Promethazine and Phenylephrine Hydrochloride Oral Solution [NEW] (USP37-NF32)

Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution [NEW]

(USP37-NF32)

Pyrantel Tartrate [NEW] (USP37-NF32)

Ropinirole Hydrochloride (USP37-NF32)

Scaffold Bovine Dermis (USP37-NF32)

Secobarbital Sodium Capsules (USP37-NF32)

Selegiline Hydrochloride Capsules [NEW] (USP37-NF32)

Sevelamer Carbonate [NEW] (USP37-NF32)

Sevelamer Carbonate for Oral Suspension [NEW] (USP37-NF32)

Sevelamer Carbonate Tablets [NEW] (USP37-NF32)

Sevelamer Hydrochloride [NEW] (USP37-NF32)

Sevelamer Hydrochloride Tablets [NEW] (USP37-NF32)

Sodium Salicylate (USP37-NF32)

Thioguanine Tablets (USP37-NF32)

Trandolapril and Verapamil Hydrochloride Extended-Release Tablets [NEW] (USP37-NF32)

Triclocarban [NEW] (USP37-NF32)

Trospium Chloride (USP37-NF32)

Zanamivir [NEW] (USP37-NF32)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

USP MONOGRAPHS

Dextrose

NF MONOGRAPHS

Ethylcellulose

STIMULI TO THE REVISION PROCESS

Stimuli To The Revision Process

An Assessment of The Impact On Pharmaceutical Product Quality Resulting From Humidity

Exposure During Distribution by Modeling Moisture Ingress

Methods for Measuring Uniformity in USP

PF 38(6): Nov.-Dec. 2012 4

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

NF MONOGRAPHS

High Fructose Corn Syrup

USP MONOGRAPHS

Escitalopram Oxalate

Famciclovir

Tamsulosin Hydrochloride Capsules

IN-PROCESS REVISION

IPR Introduction

General Notices and Requirements (USP37-NF32)

1. Title and Revision (USP37-NF32)

2. Official Status and Legal Recognition (USP37-NF32)

3. Conformance To Standards (USP37-NF32)

4. Monographs and General Chapters (USP37-NF32)

5. Monograph Components (USP37-NF32)

6. Testing Practices and Procedures (USP37-NF32)

7. Test Results

8. Terms and Definitions (USP37-NF32)

9. Prescribing and Dispensing

10. Preservation, Packaging, Storage, and Labeling (USP37-NF32)

GENERAL CHAPTERS

<5> Inhalation and Nasal Drug Products-General Information and Product Quality Tests [NEW]

(USP37-NF32)

<202> Identification of Fixed Oils by Thin-Layer Chromatography [NEW] (USP37-NF32)

<231> Heavy Metals (USP37-NF32)

<601> Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers (USP37-NF32)

<602> Propellants [NEW] (USP37-NF32)

<603> Topical Aerosols [NEW] (USP37-NF32)

<604> Leak Rate [NEW] (USP37-NF32)

<853> Fluorescence Spectroscopy [NEW] (USP37-NF32)

<1853> Fluorescence Spectroscopy-Theory and Practice [NEW] (USP37-NF32)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

PF 39(1): Jan.-Feb. 2013 1

Reagent Specifications

Nitrogen Certified Standard [NEW] (USP37-NF32)

Oxygen Certified Standard [NEW] (USP37-NF32)

21% Oxygen Certified Standard [NEW] (USP37-NF32)

93% Oxygen Certified Standard [NEW] (USP37-NF32)

Test Solutions

2 Percent Ninhydrin pH 5.2 TS [NEW] (USP37-NF32)

REFERENCE TABLES

CONTAINER SPECIFICATIONS

Containers for Dispensing Capsules and Tablets [NEW] (USP37-NF32)

DESCRIPTION AND SOLUBILITY

Description and Solubility [NEW] (USP37-NF32)

Description and Solubility - L

Description and Solubility - T

DIETARY SUPPLEMENT MONOGRAPHS

Flax Oil [NEW] (USP37-NF32)

Quercetin [NEW] (USP37-NF32)

Red Clover (USP37-NF32)

Red Clover Tablets (USP37-NF32)

Powdered Red Clover (USP37-NF32)

Powdered Red Clover Extract (USP37-NF32)

Rosemary [NEW] (USP37-NF32)

Powdered Rosemary [NEW] (USP37-NF32)

Powdered Rosemary Hydrophilic Extract [NEW] (USP37-NF32)

NF MONOGRAPHS

Tribasic Calcium Phosphate (USP37-NF32)

Sorbitan Sesquioleate (USP37-NF32)

Purified Stearic Acid (USP37-NF32)

USP MONOGRAPHS

Medical Air (USP37-NF32)

Aminobenzoate Potassium (USP37-NF32)

Aminobenzoate Sodium (USP37-NF32)

Artemether and Lumefantrine Tablets [NEW] (USP37-NF32)

Benzethonium Chloride (USP37-NF32)

Cabergoline (USP37-NF32)

Carbidopa (USP37-NF32)

Carbidopa and Levodopa Tablets (USP37-NF32)

Carbidopa and Levodopa Extended-Release Tablets [NEW] (USP37-NF32)

PF 39(1): Jan.-Feb. 2013 2

Cefazolin (USP37-NF32)

Cefazolin Sodium (USP37-NF32)

Ciprofloxacin and Dexamethasone Otic Suspension (USP37-NF32)

Deferoxamine Mesylate (USP37-NF32)

Escitalopram Oral Solution [NEW] (USP37-NF32)

Famotidine (USP37-NF32)

Formoterol Fumarate (USP37-NF32)

Hydroxocobalamin (USP37-NF32)

Lamivudine (USP37-NF32)

Lamivudine Tablets [NEW] (USP37-NF32)

Levofloxacin Tablets [NEW] (USP37-NF32)

Lidocaine Hydrochloride Jelly (USP37-NF32)

Lidocaine Ointment (USP37-NF32)

Lumefantrine [NEW] (USP37-NF32)

Methocarbamol Injection (USP37-NF32)

Metoclopramide Hydrochloride (USP37-NF32)

Metoprolol Tartrate (USP37-NF32)

Niacin (USP37-NF32)

Nimodipine (USP37-NF32)

Oxygen (USP37-NF32)

Oxygen 93 Percent (USP37-NF32)

Pectin (USP37-NF32)

Ropinirole Tablets (USP37-NF32)

Thioridazine Hydrochloride (USP37-NF32)

Tizanidine Tablets (USP37-NF32)

Topiramate Capsules [NEW] (USP37-NF32)

Topotecan Hydrochloride [NEW] (USP37-NF32)

Topotecan for Injection [NEW] (USP37-NF32)

Trazodone Hydrochloride (USP37-NF32)

Verapamil Hydrochloride (USP37-NF32)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS

Stimuli To The Revision Process

Elemental Impurities in Pharmaceutical Waters

Public Documentary Standards and Reference Materials

Responses To Public Comment about the Introduction of General Chapter <5> and Revisions to

General Chapter <601>

USP's Monographs in Support of FDA's OTC Monograph System: Modernization Opportunities

PF 39(1): Jan.-Feb. 2013 3

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

USP MONOGRAPHS

Oxycodone Hydrochloride Extended-Release Tablets (1-Sep-2013)

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<345> Assay for Citric Acid/Citrate and Phosphate (USP37-NF32 1S)

<671> Containers-Performance Testing (USP37-NF32 1S)

<787> Subvisible Particulate Matter in Therapeutic Protein Injections [NEW] (USP37-NF32 1S)

<852> Atomic Absorption Spectroscopy [NEW] (USP37-NF32 1S)

<854> Mid-Infrared Spectroscopy [NEW] (USP37-NF32 1S)

<857> Ultraviolet-Visible Spectroscopy [NEW] (USP37-NF32 1S)

<1044> Cryopreservation of Cells [NEW] (USP37-NF32 1S)

<1229.4> Sterilizing Filtration of Liquids [NEW] (USP37-NF32 1S)

<1229.10> Radiation Sterilization [NEW] (USP37-NF32 1S)

<1852> Atomic Absorption Spectroscopy-Theory and Practice [NEW] (USP37-NF32 1S)

<1854> Mid-Infrared Spectroscopy-Theory and Practice [NEW] (USP37-NF32 1S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Boldine [NEW] (USP37-NF32 1S)

CONTAINER SPECIFICATIONS

Containers for Dispensing Capsules and Tablets [NEW] (USP37-NF32 1S)

DESCRIPTION AND SOLUBILITY

Description and Solubility (USP37-NF32 1S)

Description and Solubility - D

Description and Solubility - E

Description and Solubility - S

DIETARY SUPPLEMENT MONOGRAPHS

St. John's Wort (USP37-NF32 1S)

Powdered St. John's Wort (USP37-NF32 1S)

PF 39(2): Mar.-Apr. 2013 1

Powdered St. John's Wort Extract (USP37-NF32 1S)

Powdered Valerian Extract (USP37-NF32 1S)

Vinpocetine (USP37-NF32 1S)

NF MONOGRAPHS

Benzalkonium Chloride Solution (USP37-NF32 1S)

Polyoxyl 40 Stearate (USP37-NF32 1S)

Succinic Acid (USP37-NF32 1S)

USP MONOGRAPHS

Apomorphine Hydrochloride (USP37-NF32 1S)

Aripiprazole (USP37-NF32 1S)

Atropine Sulfate (USP37-NF32 1S)

Azelastine Hydrochloride Ophthalmic Solution [NEW] (USP37-NF32 1S)

Calcium Gluconate (USP37-NF32 1S)

Cefadroxil (USP37-NF32 1S)

Cefadroxil Capsules (USP37-NF32 1S)

Cladribine Injection [NEW] (USP37-NF32 1S)

Clindamycin Phosphate (USP37-NF32 1S)

Cosyntropin [NEW] (USP37-NF32 1S)

Desloratadine [NEW] (USP37-NF32 1S)

Diethyltoluamide (USP37-NF32 1S)

Diethyltoluamide Topical Solution (USP37-NF32 1S)

Dimenhydrinate (USP37-NF32 1S)

Dipyridamole (USP37-NF32 1S)

Dutasteride [NEW] (USP37-NF32 1S)

Efavirenz Tablets [NEW] (USP37-NF32 1S)

Entecavir [NEW] (USP37-NF32 1S)

Entecavir Tablets [NEW] (USP37-NF32 1S)

Estazolam (USP37-NF32 1S)

Fluconazole Injection (USP37-NF32 1S)

Fluconazole in Dextrose Injection (USP37-NF32 1S)

Fluconazole in Sodium Chloride Injection [NEW] (USP37-NF32 1S)

Levetiracetam Tablets (USP37-NF32 1S)

Levofloxacin (USP37-NF32 1S)

Methyldopa (USP37-NF32 1S)

Padimate O (USP37-NF32 1S)

Perphenazine (USP37-NF32 1S)

Phenytoin (USP37-NF32 1S)

Phenytoin Oral Suspension (USP37-NF32 1S)

Phenytoin Chewable Tablets (USP37-NF32 1S)

Phenytoin Sodium (USP37-NF32 1S)

Extended Phenytoin Sodium Capsules (USP37-NF32 1S)

Phenytoin Sodium Injection (USP37-NF32 1S)

Pimozide (USP37-NF32 1S)

Pimozide Tablets (USP37-NF32 1S)

PF 39(2): Mar.-Apr. 2013 2

Propoxyphene Napsylate (USP37-NF32 1S)

Sufentanil Citrate (USP37-NF32 1S)

Sumatriptan Tablets (USP37-NF32 1S)

Warfarin Sodium (USP37-NF32 1S)

Warfarin Sodium for Injection (USP37-NF32 1S)

Warfarin Sodium Tablets (USP37-NF32 1S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

GENERAL CHAPTERS

<1056> Biotechnology-Derived Articles-Polyacrylamide Gel Electrophoresis

STIMULI TO THE REVISION PROCESS

Stimuli To The Revision Process

PF 39(2): Mar.-Apr. 2013 3

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

GENERAL CHAPTERS

<3> Topical and Transdermal Drug Products - Product Quality Tests (1-Nov-2013)

USP MONOGRAPHS

Orlistat (1-Nov-2013)

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<121.1> Physicochemical Analytical Procedures for Insulins [NEW] (USP37-NF32 1S)

<123> Glucagon Bioidentity Tests (USP37-NF32 1S)

<129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies [NEW]

(USP37-NF32 1S)

<202> Identification of Fixed Oils by Thin-Layer Chromatography (USP37-NF32 1S)

<227> 4-Aminophenol in Acetaminophen-Containing Drug Products [NEW] (USP37-NF32 1S)

<341> Antimicrobial Agents - Content (USP37-NF32 1S)

<551> Vitamin E Assay (USP37-NF32 1S)

<726> Electrophoresis (USP37-NF32 1S)

<851> Light-Scattering and Visual Comparison (USP37-NF32 1S)

<1094> Capsules - Dissolution Testing and Related Quality Attributes (USP37-NF32 1S)

<1229.7> Gaseous Sterilization [NEW] (USP37-NF32 1S)

<1229.8> Dry Heat Sterilization [NEW] (USP37-NF32 1S)

<1285> Preparation of Biological Specimens for Histologic and Immunohistochemical Analysis

[NEW] (USP37-NF32 1S)

<1285.1> Hematoxylin and Eosin Staining of Sectioned Tissue for Microscopic Examination

[NEW] (USP37-NF32 1S)

<2040> Disintegration and Dissolution of Dietary Supplements (USP37-NF32 1S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

2,2,2-Trichloroethanol [NEW] (USP37-NF32 1S)

Benzylparaben [NEW] (USP37-NF32 1S)

m-Cresol [NEW] (USP37-NF32 1S)

Medium-Chain Triglycerides [NEW] (USP37-NF32 1S)

PF 39(3): May-Jun. 2013 1

Pregnenolone Acetate [NEW] (USP37-NF32 1S)

t-Dodecyl Mercaptan Ethoxylate [NEW] (USP37-NF32 1S)

Chromatographic Columns

L## (Adenine, GC <227>, Acclaim Mixed-Mode WCX-1)

L79

L80

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets (USP37-NF32 1S)

Description and Solubility

Description and Solubility (USP37-NF32 1S)

Description and Solubility - A

Description and Solubility - M

Description and Solubility - O

DIETARY SUPPLEMENT MONOGRAPHS

Aztec Marigold Zeaxanthin Extract [NEW] (USP37-NF32 1S)

Calcium L-5-Methyltetrahydrofolate Capsules [NEW] (USP37-NF32 1S)

Calcium L-5-Methyltetrahydrofolate Tablets [NEW] (USP37-NF32 1S)

Fish Oil Containing Omega-3 Acids (USP37-NF32 1S)

Rhodiola Rosea [NEW] (USP37-NF32 1S)

Rhodiola Rosea Tincture [NEW] (USP37-NF32 1S)

Powdered Rhodiola Rosea [NEW] (USP37-NF32 1S)

Powdered Rhodiola Rosea Extract [NEW] (USP37-NF32 1S)

NF MONOGRAPHS

Calcium Stearate (USP37-NF32 1S)

Cholesterol (USP37-NF32 1S)

Sodium Stearate (USP37-NF32 1S)

USP MONOGRAPHS

Acetaminophen Capsules (USP37-NF32 1S)

Acetaminophen Oral Solution (USP37-NF32 1S)

Acetaminophen for Effervescent Oral Solution (USP37-NF32 1S)

Acetaminophen Suppositories (USP37-NF32 1S)

Acetaminophen Oral Suspension (USP37-NF32 1S)

Acetaminophen Tablets (USP37-NF32 1S)

Acetaminophen Extended-Release Tablets (USP37-NF32 1S)

Acetaminophen and Tramadol Hydrochloride Tablets (USP37-NF32 1S)

Tramadol Hydrochloride and Acetaminophen Tablets (USP37-NF32 1S)

PF 39(3): May-Jun. 2013 2

Amantadine Hydrochloride (USP37-NF32 1S)

Argatroban [NEW] (USP37-NF32 1S)

Aspirin Delayed-Release Tablets (USP37-NF32 1S)

Atovaquone (USP37-NF32 1S)

Aztreonam Injection (USP37-NF32 1S)

Aztreonam for Injection (USP37-NF32 1S)

Bisacodyl Delayed-Release Tablets (USP37-NF32 1S)

Butorphanol Tartrate Nasal Solution (USP37-NF32 1S)

Butorphanol Tartrate Nasal Spray (USP37-NF32 1S)

Ceftriaxone Sodium (USP37-NF32 1S)

Ceftriaxone for Injection (USP37-NF32 1S)

Chloroquine Phosphate (USP37-NF32 1S)

Corticotropin Zinc Hydroxide Injectable Suspension (USP37-NF32 1S)

Erythromycin Delayed-Release Tablets (USP37-NF32 1S)

Fluorouracil (USP37-NF32 1S)

Fluorouracil Cream (USP37-NF32 1S)

Fluorouracil Injection (USP37-NF32 1S)

Fluorouracil Topical Solution (USP37-NF32 1S)

Hydrocodone Bitartrate (USP37-NF32 1S)

Insulin Aspart (USP37-NF32 1S)

Insulin Aspart Injection (USP37-NF32 1S)

Iodixanol (USP37-NF32 1S)

Iohexol (USP37-NF32 1S)

Ketoprofen Capsules [NEW] (USP37-NF32 1S)

Lithium Carbonate Capsules (USP37-NF32 1S)

Lithium Carbonate Tablets (USP37-NF32 1S)

Lithium Carbonate Extended-Release Tablets (USP37-NF32 1S)

Magnesium Carbonate and Citric Acid for Oral Solution (USP37-NF32 1S)

Magnesium Carbonate, Citric Acid, and Potassium Citrate for Oral Solution (USP37-NF32 1S)

Magnesium Citrate for Oral Solution (USP37-NF32 1S)

Meradimate (USP37-NF32 1S)

Methsuximide (USP37-NF32 1S)

Methysergide Maleate Tablets (USP37-NF32 1S)

Metoclopramide Injection (USP37-NF32 1S)

Metoclopramide Oral Solution (USP37-NF32 1S)

Metoclopramide Tablets (USP37-NF32 1S)

Naftifine Hydrochloride (USP37-NF32 1S)

Olanzapine Orally Disintegrating Tablets [NEW] (USP37-NF32 1S)

Oxytocin Nasal Solution (USP37-NF32 1S)

Piperacillin (USP37-NF32 1S)

Piperacillin for Injection (USP37-NF32 1S)

Piperacillin Sodium (USP37-NF32 1S)

Piperacillin and Tazobactam for Injection (USP37-NF32 1S)

Prazosin Hydrochloride (USP37-NF32 1S)

Propafenone Hydrochloride Tablets [NEW] (USP37-NF32 1S)

Risperidone (USP37-NF32 1S)

Sertraline Hydrochloride (USP37-NF32 1S)

Terbinafine Hydrochloride (USP37-NF32 1S)

PF 39(3): May-Jun. 2013 3

Thiotepa (USP37-NF32 1S)

Thiotepa for Injection (USP37-NF32 1S)

Tricitrates Oral Solution (USP37-NF32 1S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS

Stimuli To The Revision Process

Confirmation of Analytical Method Calibration Linearity

Product Quality and Product Performance General Chapters

Proposed New USP General Information Chapter: Shear Cell Methodology for Powder Flow

Testing <1063>

Statistical Methods for Validation of Procedure Accuracy and Precision

PF 39(3): May-Jun. 2013 4

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

USP MONOGRAPHS

Bupropion Hydrochloride Extended-Release Tablets

Simethicone Emulsion

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<111> Design and Analysis of Biological Assays (USP37-NF32 2S)

<469> Ethylene Glycol, Diethylene Glycol, and Triethylene Glycol in Ethoxylated Substances

[NEW] (USP37-NF32 2S)

<659> Packaging and Storage Requirements (USP37-NF32 2S)

<705> Quality Attributes of Tablets Labeled As Having A Functional Score [NEW] (USP37-NF32

2S)

<724> Drug Release (USP37-NF32 2S)

<1115> Bioburden Control of Nonsterile Drug Substances and Products [NEW] (USP37-NF32 2S)

<1181> Scanning Electron Microscopy (USP37-NF32 2S)

<1229.6> Liquid-Phase Sterilization [NEW] (USP37-NF32 2S)

<1234> Vaccines for Human Use - Polysaccharide and Glycoconjugate Vaccines [NEW] (USP37-

NF32 2S)

<1240> Virus Testing of Human Plasma for Further Manufacture [NEW] (USP37-NF32 2S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

(R)-(-)-α-Phellandrene [NEW] (USP37-NF32 2S)

(+)-α-Pinene [NEW] (USP37-NF32 2S)

β-Pinene [NEW] (USP37-NF32 2S)

Brucine Sulfate (USP37-NF32 2S)

(R)-(+)-Limonene [NEW] (USP37-NF32 2S)

Sabinene [NEW] (USP37-NF32 2S)

Tetradecylammonium Bromide [NEW] (USP37-NF32 2S)

Chromatographic Columns

L81 [NEW] (USP37-NF32 2S)

PF 39(4): Jul.-Aug. 2013 1

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets [NEW] (USP37-NF32 2S)

Description and Solubility

Description and Solubility [NEW] (USP37-NF32 2S)

Description and Solubility - C

Description and Solubility - E

Description and Solubility - F

Description and Solubility - G

Description and Solubility - I

Description and Solubility - L

DIETARY SUPPLEMENT MONOGRAPHS

L-Alanyl-L-Glutamine [NEW] (USP37-NF32 2S)

Borage Oil [NEW] (USP37-NF32 2S)

Evening Primrose Oil [NEW] (USP37-NF32 2S)

Fish Oil Containing Omega-3 Acids Capsules (USP37-NF32 2S)

Fish Oil Containing Omega-3 Acids Delayed-Release Capsules (USP37-NF32 2S)

Powdered Ginkgo Extract (USP37-NF32 2S)

Glycyl-L-Glutamine [NEW] (USP37-NF32 2S)

Glycyl-L-Tyrosine [NEW] (USP37-NF32 2S)

Krill Oil (USP37-NF32 2S)

Vinpocetine Capsules [NEW] (USP37-NF32 2S)

Vinpocetine Tablets [NEW] (USP37-NF32 2S)

EXCIPIENTS

USP AND NF EXCIPIENTS, LISTED BY CATEGORY

Briefing

Introduction

Coating Agent

Flavors and Perfumes

Lubricant

Suspending and/or Viscosity-Increasing Agent

Wet Binder

NF MONOGRAPHS

Eucalyptus Oil [NEW] (USP37-NF32 2S)

Glyceryl Behenate (USP37-NF32 2S)

Glyceryl Dibehenate (USP37-NF32 2S)

USP MONOGRAPHS

Bupropion Hydrochloride (USP37-NF32 2S)

PF 39(4): Jul.-Aug. 2013 2

Calcipotriene [NEW] (USP37-NF32 2S)

Calcipotriene Ointment [NEW] (USP37-NF32 2S)

Carbamazepine Extended-Release Tablets (USP37-NF32 2S)

Carbon Monoxide C 11 (USP37-NF32 2S)

Flumazenil C 11 Injection (USP37-NF32 2S)

Mespiperone C 11 Injection (USP37-NF32 2S)

Methionine C 11 Injection (USP37-NF32 2S)

Raclopride C 11 Injection (USP37-NF32 2S)

Sodium Acetate C 11 Injection (USP37-NF32 2S)

Clarithromycin Tablets (USP37-NF32 2S)

Cupric Sulfate (USP37-NF32 2S)

Dexamethasone Oral Solution (USP37-NF32 2S)

Dexamethasone Sodium Phosphate (USP37-NF32 2S)

Dextrose Injection (USP37-NF32 2S)

Enalapril Maleate Compounded Oral Suspension, Veterinary [NEW] (USP37-NF32 2S)

Enrofloxacin Compounded Oral Suspension, Veterinary [NEW] (USP37-NF32 2S)

Felbamate (USP37-NF32 2S)

Flunixin Meglumine (USP37-NF32 2S)

Fluorodopa F 18 Injection (USP37-NF32 2S)

Gabapentin (USP37-NF32 2S)

Ibutilide Fumarate [NEW] (USP37-NF32 2S)

Insulin Glargine [NEW] (USP37-NF32 2S)

Insulin Glargine Injection [NEW] (USP37-NF32 2S)

Isradipine (USP37-NF32 2S)

Lamotrigine Compounded Oral Suspension [NEW] (USP37-NF32 2S)

Lithium Citrate (USP37-NF32 2S)

Lithium Oral Solution (USP37-NF32 2S)

Mebendazole (USP37-NF32 2S)

Mephenytoin (USP37-NF32 2S)

Mephenytoin Tablets (USP37-NF32 2S)

Metronidazole Benzoate Compounded Oral Suspension [NEW] (USP37-NF32 2S)

Mitomycin (USP37-NF32 2S)

Nadolol (USP37-NF32 2S)

Nicardipine Hydrochloride (USP37-NF32 2S)

Nicardipine Hydrochloride Injection [NEW] (USP37-NF32 2S)

Oxaprozin (USP37-NF32 2S)

Water O 15 Injection (USP37-NF32 2S)

Pentoxifylline (USP37-NF32 2S)

Phenoxybenzamine Hydrochloride Compounded Oral Suspension [NEW] (USP37-NF32 2S)

Piroxicam Compounded Oral Suspension [NEW] (USP37-NF32 2S)

Plicamycin (USP37-NF32 2S)

Plicamycin for Injection (USP37-NF32 2S)

Prednisolone Compounded Oral Suspension, Veterinary [NEW] (USP37-NF32 2S)

Prochlorperazine Maleate (USP37-NF32 2S)

Prochlorperazine Maleate Tablets (USP37-NF32 2S)

Proguanil Hydrochloride (USP37-NF32 2S)

Propranolol Hydrochloride and Hydrochlorothiazide Extended-Release Capsules (USP37-NF32 2S)

Reserpine, Hydralazine Hydrochloride, and Hydrochlorothiazide Tablets (USP37-NF32 2S)

PF 39(4): Jul.-Aug. 2013 3

Rivastigmine Transdermal System [NEW] (USP37-NF32 2S)

Salmeterol Inhalation Powder [NEW] (USP37-NF32 2S)

Sodium Phenylbutyrate [NEW] (USP37-NF32 2S)

Sulbactam Sodium (USP37-NF32 2S)

Topiramate Compounded Oral Suspension [NEW] (USP37-NF32 2S)

Trazodone Hydrochloride Tablets (USP37-NF32 2S)

Valproic Acid Capsules (USP37-NF32 2S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS

Stimuli to the Revision Process

A New General Chapter On Tablet Splitting

Metal Packaging Systems and Their Materials of Construction for Pharmaceutical Products

Overarching USP General Chapters On Good Distribution Practices

Solubility Criteria for Veterinary Drugs - Workshop Report

USP Melting Point Reference Standards: Evaluation of Parameters That Affect The Melting Point

Vibrational Circular Dichroism As A New Technology for Determining The Absolute Configuration,

Conformation, and Enantiomeric Purity of Chiral Pharmaceutical Ingredients

PF 39(4): Jul.-Aug. 2013 4

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<1> Injections (USP37-NF32 2S)

<89> Enzymes Used As Ancillary Materials in Pharmaceutical Manufacturing [NEW] (USP37-NF32

2S)

<124> Erythropoietin Bioassays [NEW] (USP37-NF32 2S)

<126> Somatropin Bioidentity Tests [NEW] (USP37-NF32 2S)

<165> Prekallikrein Activator [NEW] (USP37-NF32 2S)

<441> Niacin or Niacinamide Assay (USP37-NF32 2S)

<563> Identification of Articles of Botanical Origin (USP37-NF32 2S)

<659> Packaging and Storage Requirements (USP37-NF32 2S)

<661> Containers - Plastics (USP37-NF32 2S)

<661.1> Plastic Materials of Construction [NEW] (USP37-NF32 2S)

<661.2> Plastic Packaging Systems for Pharmaceutical Use [NEW] (USP37-NF32 2S)

<736> Mass Spectrometry (USP37-NF32 2S)

<741> Melting Range or Temperature (USP37-NF32 2S)

<751> Metal Particles in Ophthalmic Ointments (USP37-NF32 2S)

<771> Ophthalmic Ointments (USP37-NF32 2S)

<781> Optical Rotation (USP37-NF32 2S)

<791> pH (USP37-NF32 2S)

<911> Viscosity - Capillary Visometer Methods (USP37-NF32 2S)

<1081> Gel Strength of Gelatin (USP37-NF32 2S)

<1151> Pharmaceutical Dosage Forms (USP37-NF32 2S)

<1168> Compounding for Investigational Studies [NEW] (USP37-NF32 2S)

<1196>Pharmacopeial Harmonization (USP37-NF32 2S)

<1663> Assessment of Extractables Associated With Pharmaceutical Packaging/Delivery

Systems [NEW] (USP37-NF32 2S)

<1664> Assessment of Drug Product Leachables Associated With Pharmaceutical

Packaging/Delivery Systems [NEW] (USP37-NF32 2S)

<1664.1> Orally Inhaled and Nasal Drug Products [NEW] (USP37-NF32 2S)

<1736> Applications of Mass Spectrometry [NEW] (USP37-NF32 2S)

<1771> Ophthalmic Preparations - Performance Tests [NEW] (USP37-NF32 2S)

<2232> Elemental Contaminants in Dietary Supplements (USP37-NF32 2S)

<2250> Detection of Irradiated Dietary Supplements [NEW] (USP37-NF32 2S)

PF 39(5): Sep.-Oct. 2013 1

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

4-Hydroxy-2-butanone [NEW] (USP37-NF32 2S)

24,25-Dihydrolanosterol [NEW] (USP37-NF32 2S)

Butane-1,2-diol [NEW] (USP37-NF32 2S)

Butane-1,4-diol [NEW] (USP37-NF32 2S)

Butane-2,3-diol [NEW] (USP37-NF32 2S)

Cholestanol [NEW] (USP37-NF32 2S)

Methyl p-Toluenesulfonate [NEW] (USP37-NF32 2S)

Volumetric Solutions

Cupric Tartrate, Alkaline, Solution (Fehling's Solution) [NEW] (USP37-NF32 2S)

Chromatographic Columns

L82 [NEW] (USP37-NF32 2S)

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets [NEW] (USP37-NF32 2S)

Description and Solubility

Description and Solubility [NEW] (USP37-NF32 2S)

Description and Solubility - B

Description and Solubility - C

Description and Solubility - D

Description and Solubility - H

Description and Solubility - I

Description and Solubility - S

DIETARY SUPPLEMENT MONOGRAPHS

Cystine (USP37-NF32 2S)

Ganoderma Lucidum Fruiting Body [NEW] (USP37-NF32 2S)

Ganoderma Lucidum Fruiting Body Powder [NEW] (USP37-NF32 2S)

Krill Oil Capsules [NEW] (USP37-NF32 2S)

Krill Oil Delayed-Release Capsules [NEW] (USP37-NF32 2S)

Methylcobalamin [NEW] (USP37-NF32 2S)

EXCIPIENTS

USP AND NF EXCIPIENTS, LISTED BY CATEGORY

Briefing

Introduction

Coating Agent

Diluent

Emollient

Emulsifying Agent

PF 39(5): Sep.-Oct. 2013 2

Humectant

Ointment Base

Solvent

Sweetening Base

Vehicle (Oleaginous)

Wet Binder

Wetting and/or Solubilizing Agent

NF MONOGRAPHS

Butylene Glycol [NEW] (USP37-NF32 2S)

Guar Gum (USP37-NF32 2S)

Invert Sugar [NEW] (USP37-NF32 2S)

Isopropyl Myristate (USP37-NF32 2S)

Hydrogenated Lanolin [NEW] (USP37-NF32 2S)

Methylparaben Sodium (USP37-NF32 2S)

Polysorbate 80 (USP37-NF32 2S)

Propylparaben Sodium (USP37-NF32 2S)

Sucrose (USP37-NF32 2S)

Sunflower Oil (USP37-NF32 2S)

USP MONOGRAPHS

Acarbose (USP37-NF32 2S)

Amantadine Hydrochloride (USP37-NF32 2S)

Amantadine Hydrochloride Capsules (USP37-NF32 2S)

Atenolol Compounded Oral Suspension [NEW] (USP37-NF32 2S)

Atenolol Compounded Oral Suspension, Veterinary [NEW] (USP37-NF32 2S)

Atropine Sulfate Ophthalmic Ointment (USP37-NF32 2S)

Bacitracin Ophthalmic Ointment (USP37-NF32 2S)

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment (USP37-NF32 2S)

Benazepril Hydrochloride Compounded Oral Suspension, Veterinary [NEW] (USP37-NF32 2S)

Chloramphenicol Ophthalmic Ointment (USP37-NF32 2S)

Chloramphenicol and Polymyxin B Sulfate Ophthalmic Ointment (USP37-NF32 2S)

Chloramphenicol, Polymyxin B Sulfate, and Hydrocortisone Acetate Ophthalmic Ointment

(USP37-NF32 2S)

Chloramphenicol and Prednisolone Ophthalmic Ointment (USP37-NF32 2S)

Chloroxylenol (USP37-NF32 2S)

Chlortetracycline Hydrochloride Ophthalmic Ointment (USP37-NF32 2S)

Ciprofloxacin Ophthalmic Ointment (USP37-NF32 2S)

Cisatracurium Besylate [NEW] (USP37-NF32 2S)

Cisatracurium Besylate Injection [NEW] (USP37-NF32 2S)

Clopidogrel Compounded Oral Suspension [NEW] (USP37-NF32 2S)

Cryopreserved Human Fibroblast-Derived Dermal Substitute (USP37-NF32 2S)

Desonide [NEW] (USP37-NF32 2S)

Dexamethasone Tablets (USP37-NF32 2S)

Dexamethasone Sodium Phosphate Ophthalmic Ointment (USP37-NF32 2S)

PF 39(5): Sep.-Oct. 2013 3

Dextran 40 in Dextrose Injection (USP37-NF32 2S)

Dextran 70 in Dextrose Injection (USP37-NF32 2S)

Dextroamphetamine Sulfate Tablets (USP37-NF32 2S)

Doxycycline Compounded Oral Suspension, Veterinary [NEW] (USP37-NF32 2S)

Enzacamene (USP37-NF32 2S)

Erythromycin Ophthalmic Ointment (USP37-NF32 2S)

Fluphenazine Decanoate Injection (USP37-NF32 2S)

Fondaparinux Sodium [NEW] (USP37-NF32 2S)

Fondaparinux Sodium Injection [NEW] (USP37-NF32 2S)

Gentamicin and Prednisolone Acetate Ophthalmic Ointment (USP37-NF32 2S)

Gentamicin Sulfate Ophthalmic Ointment (USP37-NF32 2S)

Chorionic Gonadotropin (USP37-NF32 2S)

Chorionic Gonadotropin for Injection (USP37-NF32 2S)

Hydralazine Hydrochloride (USP37-NF32 2S)

Hydrocortisone Acetate Ophthalmic Ointment (USP37-NF32 2S)

Hydroxyzine Hydrochloride (USP37-NF32 2S)

Hydroxyzine Hydrochloride Injection (USP37-NF32 2S)

Idoxuridine Ophthalmic Ointment (USP37-NF32 2S)

Imipramine Pamoate [NEW] (USP37-NF32 2S)

Insulin Injection (USP37-NF32 2S)

Isophane Insulin Suspension (USP37-NF32 2S)

Insulin Zinc Suspension (USP37-NF32 2S)

Extended Insulin Zinc Suspension (USP37-NF32 2S)

Prompt Insulin Zinc Suspension (USP37-NF32 2S)

Isoflurophate (USP37-NF32 2S)

Isoflurophate Ophthalmic Ointment (USP37-NF32 2S)

Lansoprazole Compounded Oral Suspension [NEW] (USP37-NF32 2S)

Levobunolol Hydrochloride (USP37-NF32 2S)

Levobunolol Hydrochloride Ophthalmic Solution (USP37-NF32 2S)

Levofloxacin Injection [NEW] (USP37-NF32 2S)

Mexiletine Hydrochloride (USP37-NF32 2S)

Moricizine Hydrochloride (USP37-NF32 2S)

Naphazoline Hydrochloride Ophthalmic Solution (USP37-NF32 2S)

Naproxen Tablets (USP37-NF32 2S)

Naproxen Sodium Tablets (USP37-NF32 2S)

Neomycin Sulfate Ophthalmic Ointment (USP37-NF32 2S)

Neomycin Sulfate and Dexamethasone Sodium Phosphate Ophthalmic Ointment (USP37-NF32

2S)

Neomycin Sulfate and Hydrocortisone Acetate Ophthalmic Ointment (USP37-NF32 2S)

Neomycin and Polymyxin B Sulfates Ophthalmic Ointment (USP37-NF32 2S)

Neomycin and Polymyxin B Sulfates and Bacitracin Ophthalmic Ointment (USP37-NF32 2S)

Neomycin and Polymyxin B Sulfates, Bacitracin, and Hydrocortisone Acetate Ophthalmic

Ointment (USP37-NF32 2S)

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment (USP37-NF32 2S)

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment

(USP37-NF32 2S)

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Acetate Ophthalmic

Ointment (USP37-NF32 2S)

PF 39(5): Sep.-Oct. 2013 4

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment (USP37-NF32 2S)

Neomycin Sulfate and Prednisolone Acetate Ophthalmic Ointment (USP37-NF32 2S)

Neomycin Sulfate and Prednisolone Sodium Phosphate Ophthalmic Ointment (USP37-NF32 2S)

Neomycin Sulfate, Sulfacetamide Sodium, and Prednisolone Acetate Ophthalmic Ointment

(USP37-NF32 2S)

Neomycin Sulfate and Triamcinolone Acetonide Ophthalmic Ointment (USP37-NF32 2S)

Oleovitamin A and D Capsules (USP37-NF32 2S)

Bland Lubricating Ophthalmic Ointment (USP37-NF32 2S)

Oxymetazoline Hydrochloride Ophthalmic Solution (USP37-NF32 2S)

Oxytetracycline Hydrochloride and Polymyxin B Sulfate Ophthalmic Ointment (USP37-NF32 2S)

Paroxetine Extended-Release Tablets [NEW] (USP37-NF32 2S)

Physostigmine (USP37-NF32 2S)

Physostigmine Sulfate (USP37-NF32 2S)

Physostigmine Sulfate Ophthalmic Ointment (USP37-NF32 2S)

Pindolol (USP37-NF32 2S)

Prednisolone Sodium Phosphate Compounded Oral Solution [NEW] (USP37-NF32 2S)

Ramipril (USP37-NF32 2S)

Safflower Oil (USP37-NF32 2S)

Construct Human Fibroblasts in Polyglactin Scaffold (USP37-NF32 2S)

Construct Human Fibroblasts in Bilayer Synthetic Scaffold (USP37-NF32 2S)

Scopolamine Hydrobromide Ophthalmic Ointment (USP37-NF32 2S)

Human Fibroblast-Derived Temporary Skin Substitute (USP37-NF32 2S)

Sodium Chloride Ophthalmic Ointment (USP37-NF32 2S)

Sodium Picosulfate [NEW] (USP37-NF32 2S)

Somatropin (USP37-NF32 2S)

Somatropin for Injection (USP37-NF32 2S)

Spironolactone Compounded Oral Suspension [NEW] (USP37-NF32 2S)

Spironolactone Compounded Oral Suspension, Veterinary (USP37-NF32 2S)

Spironolactone Oral Suspension (USP37-NF32 2S)

Sulfacetamide Sodium Ophthalmic Ointment (USP37-NF32 2S)

Sulfacetamide Sodium and Prednisolone Acetate Ophthalmic Ointment (USP37-NF32 2S)

Tetracaine Ophthalmic Ointment (USP37-NF32 2S)

Tetracycline Hydrochloride Ophthalmic Ointment (USP37-NF32 2S)

Tobramycin Ophthalmic Ointment (USP37-NF32 2S)

Tobramycin and Dexamethasone Ophthalmic Ointment (USP37-NF32 2S)

Tropicamide (USP37-NF32 2S)

Vidarabine (USP37-NF32 2S)

Vidarabine Ophthalmic Ointment (USP37-NF32 2S)

Vitamin A (USP37-NF32 2S)

Vitamin A Capsules (USP37-NF32 2S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS

Stimuli to the Revision Process

PF 39(5): Sep.-Oct. 2013 5

Confirmation of Analytical Method Calibration Linearity: Practical Application

DNA-Based Methods for Authentication of Articles of Botanical Origin - Compendial Applications

Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance

Qualification, and Procedure Performance Verification

Ophthalmic Preparations

System Suitability for USP Chromatographic Procedures - Small Molecules

PF 39(5): Sep.-Oct. 2013 6

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

USP MONOGRAPHS

Acetaminophen (1-May-2014)

Loperamide Hydrochloride Oral Solution (1-May-2014)

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<7> Labeling (USP38-NF33)

<912> Rotational Rheometer Methods (USP38-NF33)

<913> Rolling Ball Viscometer Method (USP38-NF33)

<1200> Requirements for Compendial Validation [NEW] (USP38-NF33)

<1787> Measurement of Subvisible Particulate Matter in Therapeutic Protein Injections [NEW]

(USP38-NF33)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Beef Extract (USP38-NF33)

Cobaltous Acetate (USP38-NF33)

Edetic Acid [NEW] (USP38-NF33)

Magnesium Chloride (USP38-NF33)

Methylamine Hydrochloride [NEW] (USP38-NF33)

Octanesulfonic Acid Sodium Salt, Monohydrate [NEW] (USP38-NF33)

Pancreatic Digest of Casein (USP38-NF33)

Papaic Digest of Soybean Meal (USP38-NF33)

Pepsin (USP38-NF33)

Peptic Digest of Animal Tissue (USP38-NF33)

tert-Butyl Hydroperoxide Solution [NEW] (USP38-NF33)

Testosterone Benzoate (USP38-NF33)

Yeast Extract (USP38-NF33)

Chromatographic Columns

L83 [NEW] (USP38-NF33)

L84 [NEW] (USP38-NF33)

PF 39(6): Nov.-Dec. 2013 1

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets [NEW] (USP38-NF33)

Description and Solubility

Description and Solubility (USP38-NF33)

Description and Solubility - H

Description and Solubility - I

Description and Solubility - N

Description and Solubility - P

Description and Solubility - Q

Description and Solubility - T

DIETARY SUPPLEMENT MONOGRAPHS

Banaba Leaf [NEW] (USP38-NF33)

Banaba Leaf Dry Extract [NEW] (USP38-NF33)

Banaba Leaf Powder [NEW] (USP38-NF33)

Borage Seed Oil Capsules [NEW] (USP38-NF33)

Fenugreek Seed [NEW] (USP38-NF33)

Fenugreek Seed Powder [NEW] (USP38-NF33)

Fenugreek Seed Powdered Extract [NEW] (USP38-NF33)

Flax Seed Oil Capsules [NEW] (USP38-NF33)

EXCIPIENTS

USP AND NF EXCIPIENTS, LISTED BY CATEGORY

Briefing

Introduction

Coating Agent

Diluent

Film-Forming Agent

Lubricant

Ointment Base

Plasticizer

Solvent

Suppository Base

NF MONOGRAPHS

Chlorobutanol (USP38-NF33)

Methacrylic Acid Copolymer (USP38-NF33)

Methacrylic Acid Copolymer Dispersion (USP38-NF33)

Methacrylic Acid and Ethyl Acrylate Copolymer (USP38-NF33)

Methacrylic Acid and Ethyl Acrylate Copolymer Dispersion (USP38-NF33)

Methacrylic Acid and Methyl Methacrylate Copolymer (USP38-NF33)

Polyethylene Glycol (USP38-NF33)

PF 39(6): Nov.-Dec. 2013 2

USP MONOGRAPHS

Alfentanil Hydrochloride (USP38-NF33)

Amiodarone Hydrochloride Injection [NEW] (USP38-NF33)

Azathioprine (USP38-NF33)

Azithromycin (USP38-NF33)

Azithromycin for Oral Suspension (USP38-NF33)

Azithromycin Tablets (USP38-NF33)

Benzyl Benzoate (USP38-NF33)

Biotin (USP38-NF33)

Citalopram Hydrobromide (USP38-NF33)

Clofazimine (USP38-NF33)

Clotrimazole (USP38-NF33)

Cyclobenzaprine Hydrochloride Tablets (USP38-NF33)

Desipramine Hydrochloride (USP38-NF33)

Desipramine Hydrochloride Tablets (USP38-NF33)

Dinoprostone (USP38-NF33)

Diphenhydramine Hydrochloride Injection (USP38-NF33)

Duloxetine Delayed-Release Capsules (USP38-NF33)

Estradiol Cypionate (USP38-NF33)

Fluocinolone Acetonide (USP38-NF33)

Guanadrel Sulfate (USP38-NF33)

Guanadrel Sulfate Tablets (USP38-NF33)

Hydroxyzine Pamoate (USP38-NF33)

Idarubicin Hydrochloride Injection [NEW] (USP38-NF33)

Imatinib Mesylate [NEW] (USP38-NF33)

Imatinib Tablets [NEW] (USP38-NF33)

Imipenem (USP38-NF33)

Imipramine Pamoate Capsules [NEW] (USP38-NF33)

Ipratropium Bromide (USP38-NF33)

Isoniazid (USP38-NF33)

Ketoconazole (USP38-NF33)

Lidocaine Hydrochloride Topical Solution (USP38-NF33)

Lidocaine Hydrochloride Oral Topical Solution (USP38-NF33)

Magnesium Oxide (USP38-NF33)

Methocarbamol (USP38-NF33)

Methocarbamol Tablets (USP38-NF33)

Misoprostol Dispersion [NEW] (USP38-NF33)

Norelgestromin [NEW] (USP38-NF33)

Oleovitamin A and D (USP38-NF33)

Pimozide (USP38-NF33)

Polyethylene Glycol 3350 [NEW] (USP38-NF33)

Prednisone (USP38-NF33)

Prilocaine (USP38-NF33)

Prilocaine Hydrochloride (USP38-NF33)

Protamine Sulfate (USP38-NF33)

Protamine Sulfate Injection (USP38-NF33)

Protamine Sulfate for Injection (USP38-NF33)

Pyridostigmine Bromide Tablets (USP38-NF33)

PF 39(6): Nov.-Dec. 2013 3

Quetiapine Fumarate [NEW] (USP38-NF33)

Quetiapine Tablets [NEW] (USP38-NF33)

Repaglinide (USP38-NF33)

Repaglinide Tablets (USP38-NF33)

Salicylic Acid (USP38-NF33)

Sodium Bicarbonate (USP38-NF33)

Sulfamethoxazole (USP38-NF33)

Tamsulosin Hydrochloride (USP38-NF33)

Tetracaine (USP38-NF33)

Tetracaine Hydrochloride (USP38-NF33)

Tigecycline [NEW] (USP38-NF33)

Tigecycline for Injection [NEW] (USP38-NF33)

Vinorelbine Injection (USP38-NF33)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS

Stimuli to the Revision Process

Development and Application of MVTR/Unit Data in Regulatory Submissions

USP Controlled Room Temperature Range Expansion

USP Plastic Packaging General Chapters: An Overview

PF 39(6): Nov.-Dec. 2013 4

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

GENERAL CHAPTERS

<41> Balances (1-Jul-2014)

USP MONOGRAPHS

Tacrolimus Capsules (1-Jul-2014)

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<4> Mucosal Drug Products - Product Quality Tests [NEW] (USP38-NF33)

<51> Antimicrobial Effectiveness Testing (USP38-NF33)

<209> Low Molecular Weight Heparin Molecular Weight Determinations [NEW] (USP38-NF33)

<251> Lead (USP38-NF33)

<660> Containers - Glass (USP38-NF33)

<852> Atomic Absorption Spectroscopy [NEW] (USP38-NF33)

<853> Fluorescence Spectroscopy [NEW] (USP38-NF33)

<854> Mid-Infrared Spectroscopy [NEW] (USP38-NF33)

<857> Ultraviolet-Visible Spectroscopy [NEW] (USP38-NF33)

<1066> Physical Environments That Promote Safe Medication Use (USP38-NF33)

<1092> The Dissolution Procedure: Development and Validation (USP38-NF33)

<1152> Animal Drugs for Use in Animal Feeds [NEW] (USP38-NF33)

<1602> Spacers and Valved Holding Chambers Used with Inhalation Aerosols [NEW] (USP38-

NF33)

<1852> Atomic Absorption Spectroscopy - Theory and Practice [NEW] (USP38-NF33)

<1853> Fluorescence Spectroscopy - Theory and Practice [NEW] (USP38-NF33)

<1854> Mid-Infrared Spectroscopy - Theory and Practice [NEW] (USP38-NF33)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Amyl Alcohol (USP38-NF33)

Beta-Nicotinamide Adenine Dinucleotide (USP38-NF33)

Chromatographic Solvent Hexane (USP38-NF33)

Dextran, Weight-Average Molecular Weight 3,500,000 g/mol [NEW] (USP38-NF33)

Hexane, Solvent, Chromatographic (USP38-NF33)

PF 40(1): Jan.-Feb. 2014 1

Hydrocodone diol [NEW] (USP38-NF33)

Magnesium Nitrate (USP38-NF33)

Myristyltrimethylammonium Bromide [NEW] (USP38-NF33)

Polyethylene Glycol Standards with Molecular Weights of 960, 1960, 3020, 6430, and 12,300

Daltons (g/mol) [NEW] (USP38-NF33)

Test Solutions

Lead Nitrate Stock Solution TS [NEW] (USP38-NF33)

Standard Lead Solution (USP38-NF33)

Volumetric Solutions

Lithium Methoxide, Fiftieth-Normal (0.02 N) in Methanol (USP38-NF33)

Perchloric Acid, Tenth-Normal (0.1 N) in Dioxane (USP38-NF33)

Chromatographic Columns

L## (Polyethylene Glycol 3350, Aquagel-OH40) [NEW] (USP38-NF33)

L## (Polyethylene Glycol 3350, TSKgel G-Oligo-PW) [NEW] (USP38-NF33)

L24 (USP38-NF33

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets [NEW] (USP38-NF33)

Description and Solubility

Description and Solubility [NEW] (USP38-NF33)

Description and Solubility - I

DIETARY SUPPLEMENT MONOGRAPHS

Menaquinone-7 [NEW] (USP38-NF33)

Menaquinone-7 Preparation [NEW] (USP38-NF33)

NF MONOGRAPHS

Anethole (USP38-NF33)

Bentonite (USP38-NF33)

Purified Bentonite (USP38-NF33)

Calcium Propionate (USP38-NF33)

Cetyl Alcohol (USP38-NF33)

Corn Syrup (USP38-NF33)

Corn Syrup Solids (USP38-NF33)

High Fructose Corn Syrup (USP38-NF33)

Desoxycholic Acid (USP38-NF33)

Erythritol (USP38-NF33)

Magnesium Aluminum Silicate (USP38-NF33)

Myristyl Alcohol (USP38-NF33)

Hydrophobic Colloidal Silica (USP38-NF33)

PF 40(1): Jan.-Feb. 2014 2

Stannous Chloride (USP38-NF33)

USP MONOGRAPHS

Amiloride Hydrochloride (USP38-NF33)

Benzocaine (USP38-NF33)

Betaxolol Ophthalmic Solution (USP38-NF33)

Brinzolamide (USP38-NF33)

Brinzolamide Ophthalmic Suspension (USP38-NF33)

Cefotaxime Sodium (USP38-NF33)

Cloprostenol Sodium (USP38-NF33)

Cromolyn Sodium (USP38-NF33)

Cromolyn Sodium Inhalation Solution (USP38-NF33)

Cromolyn Sodium Nasal Solution (USP38-NF33)

Cromolyn Sodium Ophthalmic Solution (USP38-NF33)

Dexchlorpheniramine Maleate Tablets (USP38-NF33)

Dipivefrin Hydrochloride (USP38-NF33)

Dipivefrin Hydrochloride Ophthalmic Solution (USP38-NF33)

Dyphylline and Guaifenesin Oral Solution (USP38-NF33)

Epitetracycline Hydrochloride (USP38-NF33)

Ergotamine Tartrate and Caffeine Tablets (USP38-NF33)

Fluorometholone (USP38-NF33)

Fluorometholone Ophthalmic Suspension (USP38-NF33)

Flurbiprofen Tablets (USP38-NF33)

Formoterol Fumarate (USP38-NF33)

Histidine (USP38-NF33)

Indomethacin (USP38-NF33)

Latanoprost (USP38-NF33)

Levodopa (USP38-NF33)

Lindane Cream (USP38-NF33)

Lithium Carbonate (USP38-NF33)

Magnesium Salicylate (USP38-NF33)

Methimazole (USP38-NF33)

Methimazole Tablets (USP38-NF33)

Metronidazole Tablets (USP38-NF33)

Niacin (USP38-NF33)

Olanzapine Tablets (USP38-NF33)

Oxaprozin Tablets (USP38-NF33)

Phenytoin (USP38-NF33)

Phenytoin Oral Suspension (USP38-NF33)

Pyrantel Tartrate [NEW] (USP38-NF33)

Sulfamethoxazole and Trimethoprim Oral Suspension (USP38-NF33)

Sulindac (USP38-NF33)

Thiopental Sodium for Injection (USP38-NF33)

Venlafaxine Hydrochloride (USP38-NF33)

Venlafaxine Tablets (USP38-NF33)

Vigabatrin for Oral Solution [NEW] (USP38-NF33)

PF 40(1): Jan.-Feb. 2014 3

Vigabatrin Tablets [NEW] (USP38-NF33)

Zinc Carbonate (USP38-NF33)

Zinc Chloride (USP38-NF33)

Zinc Sulfate (USP38-NF33)

Zinc Sulfate Tablets (USP38-NF33)

Ziprasidone Hydrochloride (USP38-NF33)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS

Stimuli to the Revision Process

An Alignment of Concepts and Content across the Spectroscopy General Chapters in the United

States Pharmacopeia-National Formulary (USP-NF)

Revision of The Dissolution Procedure: Development and Validation <1092>

Stimulus To Revision: A Rational Approach To Cascade Impactor Mensuration in a Good Cascade

Impactor Practice (GCIP) Environment

PF 40(1): Jan.-Feb. 2014 4

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

NF MONOGRAPHS

Polysorbate 20 (1-Sep-2014)

USP MONOGRAPHS

Cefdinir Capsules (1-Sep-2014)

Cefdinir for Oral Suspension (1-Sep-2014)

Chlorhexidine Acetate (1-Sep-2014)

Chlorhexidine Gluconate Solution (1-Sep-2014)

Chlorhexidine Hydrochloride (1-Sep-2014)

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<3> Topical and Transdermal Drug Products - Product Quality Tests (USP38-NF33 1S)

<232> Elemental Impurities - Limits (USP38-NF33 1S)

<233> Elemental Impurities - Procedures (USP38-NF33 1S)

<1083> Good Distribution Practices [NEW] (USP38-NF33 1S)

<1083.1> Quality Management System [NEW] (USP38-NF33 1S)

<1083.2> Environmental Conditions Management [NEW] (USP38-NF33 1S)

<1083.3> Good Importation and Exportation Practices [NEW] (USP38-NF33 1S)

<1083.4> Supply Chain Integrity and Security [NEW] (USP38-NF33 1S)

<1130> Nucleic Acid-Based Techniques - Approaches for Detecting Trace Nucleic Acids

(Residual DNA Testing) (USP38-NF33 1S)

<1228> Depyrogenation [NEW] (USP38-NF33 1S)

<1229.11> Vapor Phase Sterilization [NEW] (USP38-NF33 1S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Fuchsin, Basic (USP38-NF33 1S)

4-Nitrobenzoic Acid [NEW] (USP38-NF33 1S)

1-Pentadecanol [NEW] (USP38-NF33 1S)

Volumetric Solutions

Lithium Methoxide, Tenth-Normal (0.1 N) in Chlorobenzene (USP38-NF33 1S)

PF 40(2): Mar.-Apr. 2014 1

Lithium Methoxide, Tenth-Normal (0.1 N) in Methanol (USP38-NF33 1S)

Lithium Methoxide, Tenth-Normal (0.1 N) in Toluene (USP38-NF33 1S)

Chromatographic Columns

L86 [NEW] (USP38-NF33 1S)

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets [NEW] (USP38-NF33 1S)

Description and Solubility

Description and Solubility [NEW] (USP38-NF33 1S)

Description and Solubility - A

Description and Solubility - D

Description and Solubility - L

Description and Solubility - R

Description and Solubility - T

DIETARY SUPPLEMENT MONOGRAPHS

5-Hydroxy-L-tryptophan [NEW] (USP38-NF33 1S)

Menaquinone-7 Capsules [NEW] (USP38-NF33 1S)

Menaquinone-7 Tablets [NEW] (USP38-NF33 1S)

Northern Schisandra Fruit [NEW] (USP38-NF33 1S)

Northern Schisandra Fruit Powder [NEW] (USP38-NF33 1S)

Tienchi Ginseng Root and Rhizome [NEW] (USP38-NF33 1S)

Tienchi Ginseng Root and Rhizome Dry Extract [NEW] (USP38-NF33 1S)

Tienchi Ginseng Root and Rhizome Powder [NEW] (USP38-NF33 1S)

NF MONOGRAPHS

Butylated Hydroxytoluene (USP38-NF33 1S)

Cetostearyl Alcohol (USP38-NF33 1S)

Methyl Salicylate (USP38-NF33 1S)

Octyldodecanol (USP38-NF33 1S)

Oleyl Alcohol (USP38-NF33 1S)

Potassium Metaphosphate (USP38-NF33 1S)

Stearyl Alcohol (USP38-NF33 1S)

USP MONOGRAPHS

Alanine (USP38-NF33 1S)

Aminolevulinic Acid Hydrochloride [NEW] (USP38-NF33 1S)

Amlodipine and Valsartan Tablets [NEW] (USP38-NF33 1S)

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets [NEW] (USP38-NF33 1S)

Amobarbital Sodium for Injection (USP38-NF33 1S)

PF 40(2): Mar.-Apr. 2014 2

Atazanavir Sulfate [NEW] (USP38-NF33 1S)

Atazanavir Capsules [NEW] (USP38-NF33 1S)

Benzocaine Ointment (USP38-NF33 1S)

Buprenorphine Compounded Buccal Solution, Veterinary [NEW] (USP38-NF33 1S)

Chlordiazepoxide Hydrochloride for Injection (USP38-NF33 1S)

Diclofenac Sodium and Misoprostol Delayed-Release Tablets [NEW] (USP38-NF33 1S)

Diphenhydramine Hydrochloride Capsules (USP38-NF33 1S)

Diphenoxylate Hydrochloride (USP38-NF33 1S)

Donepezil Hydrochloride (USP38-NF33 1S)

Econazole Nitrate (USP38-NF33 1S)

Epirubicin Hydrochloride (USP38-NF33 1S)

Epirubicin Hydrochloride Injection [NEW] (USP38-NF33 1S)

Galantamine Extended-Release Capsules [NEW] (USP38-NF33 1S)

Halobetasol Propionate (USP38-NF33 1S)

Levocarnitine Injection (USP38-NF33 1S)

Levocetirizine Dihydrochloride [NEW] (USP38-NF33 1S)

Levocetirizine Dihydrochloride Tablets [NEW] (USP38-NF33 1S)

Loperamide Hydrochloride Tablets (USP38-NF33 1S)

Nicotine (USP38-NF33 1S)

Nicotine Polacrilex (USP38-NF33 1S)

Norfloxacin (USP38-NF33 1S)

Oxymetazoline Hydrochloride (USP38-NF33 1S)

Phenylephrine Bitartrate (USP38-NF33 1S)

Phenylephrine Hydrochloride (USP38-NF33 1S)

Phenytoin Sodium (USP38-NF33 1S)

Rosuvastatin Calcium [NEW] (USP38-NF33 1S)

Selegiline Hydrochloride Compounded Topical Gel [NEW] (USP38-NF33 1S)

Tadalafil Compounded Oral Suspension [NEW] (USP38-NF33 1S)

Temazepam (USP38-NF33 1S)

Tetracycline (USP38-NF33 1S)

Tetracycline Hydrochloride (USP38-NF33 1S)

Timolol Maleate (USP38-NF33 1S)

Tolterodine Tartrate [NEW] (USP38-NF33 1S)

Tramadol Hydrochloride Compounded Oral Suspension, Veterinary [NEW] (USP38-NF33 1S)

Valine (USP38-NF33 1S)

Voriconazole Compounded Ophthalmic Solution, Veterinary [NEW] (USP38-NF33 1S)

Zonisamide Compounded Oral Suspension [NEW] (USP38-NF33 1S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS

Stimuli to the Revision Process

Name Confusion Between Hydromorphone and Morphine: Safety in Patient Care

Pharmaceutical Packaging: Moisture Permeation and Integrity Testing

PF 40(2): Mar.-Apr. 2014 3

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

USP MONOGRAPHS

Dextromethorphan (1-Nov-2014)

Dextromethorphan Hydrobromide (1-Nov-2014)

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<161> Transfusion and Infusion Assemblies and Similar Medical Devices (USP38-NF33 1S)

<202> Identification of Fixed Oils by Thin-Layer Chromatography [NEW] (USP38-NF33 1S)

<203> High-Performance Thin-Layer Chromatography Procedure for Identification of Articles of

Botanical Origin [NEW] (USP38-NF33 1S)

<212> Oligosaccharide Analysis [NEW] (USP38-NF33 1S)

<361> Barbiturate Assay (USP38-NF33 1S)

<476> Organic Impurities in Drug Substances and Drug Products [NEW] (USP38-NF33 1S)

<789> Particulate Matter in Ophthalmic Solutions (USP38-NF33 1S)

<800> Hazardous Drugs - Handling in Healthcare Settings [NEW] (USP38-NF33 1S)

<1010> Analytical Data - Interpretation and Treatment (USP38-NF33 1S)

<1029> Good Documentation Guidelines [NEW] (USP38-NF33 1S)

<1064> Identification of Articles of Botanical Origin Using High-Performance Thin-Layer

Chromatographic Procedure [New] (USP38-NF33 1S)

<1065> Ion Chromatography (USP38-NF33 1S)

<1086> Impurities in Drug Substances and Drug Products (USP38-NF33 1S)

<1106.1> Immunogenicity Assays - Design and Validation of Assays To Detect Anti-Drug

Neutralizing Antibody [NEW] (USP38-NF33 1S)

<1160> Pharmaceutical Calculations in Prescription Compounding (USP38-NF33 1S)

<1228.1> Dry Heat Depyrogenation [NEW] (USP38-NF33 1S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Bismuth [New] (USP38-NF33 1S)

15-Epicarboprost [New] (USP38-NF33 1S)

Molybdenum [New] (USP38-NF33 1S)

1-Monodecanoyl-rac-glycerol [New] (USP38-NF33 1S)

1-Monooctanoyl-rac-glycerol [New] (USP38-NF33 1S)

PF 40(3): May-Jun. 2014 1

Colorimetric Solutions

Buffer Solutions (USP38-NF33 1S)

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets [NEW] (USP38-NF33 1S)

Description and Solubility

Description and Solubility [NEW] (USP38-NF33 1S)

Description and Solubility - A

Description and Solubility - G

Description and Solubility - M

DIETARY SUPPLEMENT MONOGRAPHS

Astragalus Root [NEW] (USP38-NF33 1S)

Astragalus Root Dry Extract [NEW] (USP38-NF33 1S)

Astragalus Root Powder [NEW] (USP38-NF33 1S)

Bacillus subtilis subsp. subtilis Menaquinone-7 Extract [NEW] (USP38-NF33 1S)

EXCIPIENTS

USP AND NF EXCIPIENTS, LISTED BY CATEGORY

Briefing

Introduction

Emulsifying Agent

Lubricant

NF MONOGRAPHS

Ethyl Acetate (USP38-NF33 1S)

Glyceryl Monocaprylate [NEW] (USP38-NF33 1S)

Glyceryl Monocaprylocaprate [NEW] (USP38-NF33 1S)

USP MONOGRAPHS

Acebutolol Hydrochloride (USP38-NF33 1S)

Almotriptan Malate [NEW] (USP38-NF33 1S)

Almotriptan Tablets [NEW] (USP38-NF33 1S)

Amlodipine Besylate Tablets (USP38-NF33 1S)

Anastrozole Tablets [NEW] (USP38-NF33 1S)

Antipyrine (USP38-NF33 1S)

Benzocaine Cream (USP38-NF33 1S)

Benzocaine Gel (USP38-NF33 1S)

Butabarbital Sodium Oral Solution (USP38-NF33 1S)

Butabarbital Sodium Tablets (USP38-NF33 1S)

PF 40(3): May-Jun. 2014 2

Urea C 13 for Oral Solution (USP38-NF33 1S)

Ciclopirox Olamine (USP38-NF33 1S)

Ciprofloxacin (USP38-NF33 1S)

Ciprofloxacin Hydrochloride (USP38-NF33 1S)

Clotrimazole Cream (USP38-NF33 1S)

Clotrimazole Topical Solution (USP38-NF33 1S)

Doxazosin Mesylate (USP38-NF33 1S)

Doxorubicin Hydrochloride (USP38-NF33 1S)

Doxorubicin Hydrochloride Injection (USP38-NF33 1S)

Esmolol Hydrochloride (USP38-NF33 1S)

Flumazenil (USP38-NF33 1S)

Flumazenil Injection (USP38-NF33 1S)

Galantamine Oral Solution [NEW] (USP38-NF33 1S)

Glycine (USP38-NF33 1S)

Gonadorelin Acetate (USP38-NF33 1S)

Ifosfamide Injection [NEW] (USP38-NF33 1S)

Imiquimod Cream [NEW] (USP38-NF33 1S)

Indomethacin Suppositories (USP38-NF33 1S)

Levalbuterol Hydrochloride (USP38-NF33 1S)

Levetiracetam Injection [NEW] (USP38-NF33 1S)

Linezolid [NEW] (USP38-NF33 1S)

Metaxalone [NEW] (USP38-NF33 1S)

Metaxalone Tablets [NEW] (USP38-NF33 1S)

Metronidazole Injection (USP38-NF33 1S)

Milrinone (USP38-NF33 1S)

Minocycline Hydrochloride Extended-Release Tablets [NEW] (USP38-NF33 1S)

Propafenone Hydrochloride Extended-Release Capsules [NEW] (USP38-NF33 1S)

Sodium Salicylate (USP38-NF33 1S)

Sulfamethoxazole and Trimethoprim Tablets (USP38-NF33 1S)

Tetracycline Hydrochloride Capsules (USP38-NF33 1S)

Ticarcillin Disodium (USP38-NF33 1S)

Ticarcillin Monosodium (USP38-NF33 1S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

GENERAL CHAPTERS

<1055> Biotechnology-Derived Articles - Peptide Mapping

NF MONOGRAPHS

Low-Substituted Hydroxypropyl Cellulose

Sodium Lauryl Sulfate

PF 40(3): May-Jun. 2014 3

USP MONOGRAPHS

Povidone

STIMULI TO THE REVISION PROCESS

Stimuli To The Revision Process

Modernization of Organic Impurities Testing in USP Drug Substance and Drug Product

Monographs

PF 40(3): May-Jun. 2014 4

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

USP MONOGRAPHS

Calcitonin Salmon Injection (1-Jan-2015)

Calcitonin Salmon Nasal Solution (1-Jan-2015)

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<31> Volumetric Apparatus (USP38-NF33 2S)

<111> Design and Analysis of Biological Assays (USP38-NF33 2S)

<411> Folic Acid Assay (USP38-NF33 2S)

<755> Minimum Fill (USP38-NF33 2S)

<909> Uniformity of Dose From Oral Suspensions in Multiple-Unit Containers [NEW] (USP38-

NF33 2S)

<1132> Residual Host Cell Protein Measurement in Biopharmaceuticals [NEW] (USP38-NF33 2S)

<1223> Validation of Alternative Microbiological Methods (USP38-NF33 2S)

<1223.1> Validation of Alternative Methods To Antibiotic Microbial Assays [NEW] (USP38-NF33

2S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Iminodiacetic Acid [NEW] (USP38-NF33 2S)

Iron (Powder) [NEW] (USP38-NF33 2S)

Manganese [NEW] (USP38-NF33 2S)

Sodium Stearyl Fumarate [NEW] (USP38-NF33 2S)

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets [NEW] (USP38-NF33 2S)

Description and Solubility

Description and Solubility (USP38-NF33 2S)

Description and Solubility - C

Description and Solubility - M

Description and Solubility - S

PF 40(4): Jul.-Aug. 2014 1

NF MONOGRAPHS

Aspartame (USP38-NF33 2S)

Isopropyl Palmitate (USP38-NF33 2S)

Olive Oil (USP38-NF33 2S)

Shellac (USP38-NF33 2S)

USP MONOGRAPHS

Aspartic Acid (USP38-NF33 2S)

Azatadine Maleate (USP38-NF33 2S)

Benzocaine Topical Aerosol (USP38-NF33 2S)

Benzocaine Topical Solution (USP38-NF33 2S)

Budesonide (USP38-NF33 2S)

Buspirone Hydrochloride (USP38-NF33 2S)

Buspirone Hydrochloride Tablets (USP38-NF33 2S)

Calcium Succinate [NEW] (USP38-NF33 2S)

Carbamazepine (USP38-NF33 2S)

Carbamazepine Oral Suspension (USP38-NF33 2S)

Carbamazepine Tablets (USP38-NF33 2S)

Carboprost Tromethamine (USP38-NF33 2S)

Ceftiofur Hydrochloride [NEW] (USP38-NF33 2S)

Ceftiofur Sodium [NEW] (USP38-NF33 2S)

Cyclobenzaprine Hydrochloride Extended-Release Capsules [NEW] (USP38-NF33 2S)

Dexamethasone Sodium Phosphate (USP38-NF33 2S)

Doxorubicin Hydrochloride for Injection (USP38-NF33 2S)

Fluoxetine Delayed-Release Capsules (USP38-NF33 2S)

Fluoxetine Tablets (USP38-NF33 2S)

Gemfibrozil Tablets (USP38-NF33 2S)

Gonadorelin Hydrochloride (USP38-NF33 2S)

Halcinonide Cream (USP38-NF33 2S)

Halcinonide Ointment (USP38-NF33 2S)

Hydrocodone Bitartrate and Homatropine Methylbromide Tablets (USP38-NF33 2S)

Iron Dextran Injection (USP38-NF33 2S)

Isoflurane (USP38-NF33 2S)

Ketoconazole (USP38-NF33 2S)

Ketorolac Tromethamine Injection (USP38-NF33 2S)

Lamotrigine Extended-Release Tablets [NEW] (USP38-NF33 2S)

Lidocaine (USP38-NF33 2S)

Lopinavir and Ritonavir Oral Solution [NEW] (USP38-NF33 2S)

Magnesium Salicylate Tablets (USP38-NF33 2S)

Metformin Hydrochloride (USP38-NF33 2S)

Metformin Hydrochloride Tablets (USP38-NF33 2S)

Metformin Hydrochloride Extended-Release Tablets (USP38-NF33 2S)

Metronidazole Gel (USP38-NF33 2S)

Milbemycin Oxime [NEW] (USP38-NF33 2S)

Nadolol (USP38-NF33 2S)

Ritonavir Oral Solution (USP38-NF33 2S)

Rizatriptan Benzoate Tablets [NEW] (USP38-NF33 2S)

PF 40(4): Jul.-Aug. 2014 2

Rizatriptan Benzoate Orally Disintegrating Tablets [NEW] (USP38-NF33 2S)

Salicylic Acid Gel (USP38-NF33 2S)

Sertraline Hydrochloride Tablets (USP38-NF33 2S)

Sitagliptin Phosphate [NEW] (USP38-NF33 2S)

Sitagliptin Tablets [NEW] (USP38-NF33 2S)

Sodium Salicylate Tablets (USP38-NF33 2S)

Soybean Oil (USP38-NF33 2S)

Sulindac Tablets (USP38-NF33 2S)

Trihexyphenidyl Hydrochloride (USP38-NF33 2S)

Urea (USP38-NF33 2S)

Zinc Oxide (USP38-NF33 2S)

Zinc Oxide Neutral (USP38-NF33 2S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS

Stimuli To The Revision Process

Modernization of Asbestos Testing in USP Talc

Physico-Chemical Method for The Prediction of The Bioactivity of Epoetin Beta Batches

Proposed New USP General Information Chapter ''Tablet Compression Characterization <1062>''

PF 40(4): Jul.-Aug. 2014 3

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

GENERAL CHAPTERS

<121> Insulin Assays (1-Mar-2015)

DIETARY SUPPLEMENT MONOGRAPHS

Ganoderma Lucidum Fruiting Body (1-Mar-2015)

Ganoderma Lucidum Fruiting Body Powder (1-Mar-2015)

USP MONOGRAPHS

Omega-3-Acid Ethyl Esters (1-Mar-2015)

Omega-3-Acid Ethyl Esters Capsules (1-Mar-2015)

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<162> Diphtheria Antitoxin Potency Testing for Human Immune Globulins [NEW] (USP38-NF33

2S)

<381> Elastomeric Closures for Injections (USP38-NF33 2S)

<561> Articles of Botanical Origin (USP38-NF33 2S)

<565> Botanical Extracts (USP38-NF33 2S)

<580> Vitamin C Assay [NEW] (USP38-NF33 2S)

<661> Containers - Plastics (USP38-NF33 2S)

<661.1> Plastic Materials of Construction [NEW] (USP38-NF33 2S)

<661.2> Plastic Packaging Systems for Pharmaceutical Use [NEW] (USP38-NF33 2S)

<1025> Pancreatin [NEW] (USP38-NF33 2S)

<1041> Biologics (USP38-NF33 2S)

<1045> Biotechnology-Derived Articles (USP38-NF33 2S)

<1059> Excipient Performance (USP38-NF33 2S)

<1080> Bulk Pharmaceutical Excipients - Certificate of Analysis (USP38-NF33 2S)

<1207> Sterile Product Packaging - Integrity Evaluation (USP38-NF33 2S)

<1207.1> Package Integrity and Test Method Selection [NEW] (USP38-NF33 2S)

<1207.2> Package Integrity Leak Test Technologies [NEW] (USP38-NF33 2S)

<1207.3> Package Seal Quality Test Methods [NEW] (USP38-NF33 2S)

<1210> Statistical Tools for Procedure Validation [NEW] (USP38-NF33 2S)

PF 40(5): Sep.-Oct. 2014 1

Chromatographic Columns

L## (Dalteparin Sodium, Dionex Ionpac As15) [NEW] (USP38-NF33 2S)

L## (Teriparatide Acetate, Dionex Ionpac As4a, Dionex Ionpac Ag4a) [NEW] (USP38-NF33 2S)

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets [NEW] (USP38-NF33 2S)

Description and Solubility

Description and Solubility [NEW] (USP38-NF33 2S)

Description and Solubility - E

Description and Solubility - M

DIETARY SUPPLEMENT MONOGRAPHS

American Ginseng (USP38-NF33 2S)

Powdered American Ginseng (USP38-NF33 2S)

Andrographis (USP38-NF33 2S)

Powdered Andrographis (USP38-NF33 2S)

Ashwagandha Root (USP38-NF33 2S)

Powdered Ashwagandha Root (USP38-NF33 2S)

Asian Ginseng (USP38-NF33 2S)

Powdered Asian Ginseng (USP38-NF33 2S)

Aztec Marigold Zeaxanthin Extract (USP38-NF33 2S)

Bacopa (USP38-NF33 2S)

Powdered Bacopa (USP38-NF33 2S)

Black Cohosh (USP38-NF33 2S)

Powdered Black Cohosh (USP38-NF33 2S)

Black Pepper (USP38-NF33 2S)

Powdered Black Pepper (USP38-NF33 2S)

Boswellia Serrata (USP38-NF33 2S)

Calcium with Vitamin D Tablets (USP38-NF33 2S)

Calcium and Vitamin D with Minerals Tablets (USP38-NF33 2S)

Cat's Claw (USP38-NF33 2S)

Powdered Cat's Claw (USP38-NF33 2S)

Centella Asiatica (USP38-NF33 2S)

Powdered Centella Asiatica (USP38-NF33 2S)

Chaste Tree (USP38-NF33 2S)

Powdered Chaste Tree (USP38-NF33 2S)

Horse Chestnut (USP38-NF33 2S)

Powdered Horse Chestnut (USP38-NF33 2S)

Cinnamomum Cassia Bark [NEW] (USP38-NF33 2S)

Cinnamomum Cassia Bark Powder [NEW] (USP38-NF33 2S)

Cinnamomum Verum Bark [NEW] (USP38-NF33 2S)

Cinnamomum Verum Bark Powder [NEW] (USP38-NF33 2S)

Crypthecodinium Cohnii Oil (USP38-NF33 2S)

Crypthecodinium Cohnii Oil Capsules (USP38-NF33 2S)

PF 40(5): Sep.-Oct. 2014 2

Eleuthero (USP38-NF33 2S)

Powdered Eleuthero (USP38-NF33 2S)

Evening Primrose Oil Capsules [NEW] (USP38-NF33 2S)

Feverfew (USP38-NF33 2S)

Powdered Feverfew (USP38-NF33 2S)

Fish Oil Containing Omega-3 Acids (USP38-NF33 2S)

Fish Oil Containing Omega-3 Acids Capsules (USP38-NF33 2S)

Forskohlii (USP38-NF33 2S)

Powdered Forskohlii (USP38-NF33 2S)

Garcinia Cambogia (USP38-NF33 2S)

Powdered Garcinia Cambogia (USP38-NF33 2S)

Garcinia Indica (USP38-NF33 2S)

Powdered Garcinia Indica (USP38-NF33 2S)

Garlic (USP38-NF33 2S)

Powdered Garlic (USP38-NF33 2S)

Ginger (USP38-NF33 2S)

Powdered Ginger (USP38-NF33 2S)

Ginkgo (USP38-NF33 2S)

Goldenseal (USP38-NF33 2S)

Powdered Goldenseal (USP38-NF33 2S)

Guggul (USP38-NF33 2S)

Gymnema (USP38-NF33 2S)

Powdered Gymnema (USP38-NF33 2S)

Hawthorn Leaf with Flower (USP38-NF33 2S)

Powdered Hawthorn Leaf with Flower (USP38-NF33 2S)

Licorice (USP38-NF33 2S)

Powdered Licorice (USP38-NF33 2S)

Malabar-Nut-Tree, Leaf (USP38-NF33 2S)

Powdered Malabar-Nut-Tree, Leaf (USP38-NF33 2S)

Milk Thistle (USP38-NF33 2S)

Powdered Milk Thistle (USP38-NF33 2S)

Minerals Capsules (USP38-NF33 2S)

Minerals Tablets (USP38-NF33 2S)

Omega-3 Acid Triglycerides (USP38-NF33 2S)

Phyllanthus Amarus (USP38-NF33 2S)

Powdered Phyllanthus Amarus (USP38-NF33 2S)

Pygeum (USP38-NF33 2S)

St. John's Wort (USP38-NF33 2S)

Powdered St. John's Wort (USP38-NF33 2S)

Saw Palmetto (USP38-NF33 2S)

Powdered Saw Palmetto (USP38-NF33 2S)

Schizochytrium Oil (USP38-NF33 2S)

Schizochytrium Oil Capsules (USP38-NF33 2S)

Turmeric (USP38-NF33 2S)

Powdered Turmeric (USP38-NF33 2S)

Ubiquinol [NEW] (USP38-NF33 2S)

Oil-Soluble Vitamins Capsules (USP38-NF33 2S)

Oil-Soluble Vitamins Tablets (USP38-NF33 2S)

PF 40(5): Sep.-Oct. 2014 3

Oil-Soluble Vitamins with Minerals Capsules (USP38-NF33 2S)

Oil-Soluble Vitamins with Minerals Tablets (USP38-NF33 2S)

Oil- and Water-Soluble Vitamins Capsules (USP38-NF33 2S)

Oil- and Water-Soluble Vitamins Oral Solution (USP38-NF33 2S)

Oil- and Water-Soluble Vitamins Tablets (USP38-NF33 2S)

Oil- and Water-Soluble Vitamins with Minerals Capsules (USP38-NF33 2S)

Oil- and Water-Soluble Vitamins with Minerals Oral Solution (USP38-NF33 2S)

Oil- and Water-Soluble Vitamins with Minerals Tablets (USP38-NF33 2S)

Water-Soluble Vitamins Capsules (USP38-NF33 2S)

Water-Soluble Vitamins Tablets (USP38-NF33 2S)

Water-Soluble Vitamins with Minerals Capsules (USP38-NF33 2S)

Water-Soluble Vitamins with Minerals Oral Solution (USP38-NF33 2S)

Water-Soluble Vitamins with Minerals Tablets (USP38-NF33 2S)

NF MONOGRAPHS

Low-Substituted Carboxymethylcellulose Sodium (USP38-NF33 2S)

Pharmaceutical Glaze (USP38-NF33 2S)

Trehalose (USP38-NF33 2S)

Zein (USP38-NF33 2S)

USP MONOGRAPHS

Capsules Containing at Least Three of the Following - Acetaminophen and Salts of

Chlorpheniramine, Dextromethorphan, and Phenylpropanolamine (USP38-NF33 2S)

Oral Solution Containing at Least Three of the Following - Acetaminophen and Salts of

Chlorpheniramine, Dextromethorphan, and Phenylpropanolamine (USP38-NF33 2S)

Tablets Containing at Least Three of the Following - Acetaminophen and Salts of

Chlorpheniramine, Dextromethorphan, and Phenylpropanolamine (USP38-NF33 2S)

Acetazolamide Compounded Oral Suspension (USP38-NF33 2S)

Allopurinol Compounded Oral Suspension (USP38-NF33 2S)

Alprazolam Compounded Oral Suspension (USP38-NF33 2S)

Amantadine Hydrochloride (USP38-NF33 2S)

Amiodarone Hydrochloride Compounded Oral Suspension (USP38-NF33 2S)

Amlodipine Compounded Oral Suspension (USP38-NF33 2S)

Atenolol Compounded Oral Solution (USP38-NF33 2S)

Azathioprine Compounded Oral Suspension(USP38-NF33 2S)

Baclofen Compounded Oral Suspension (USP38-NF33 2S)

Beclomethasone Dipropionate Compounded Oral Solution [NEW] (USP38-NF33 2S)

Benzocaine Otic Solution (USP38-NF33 2S)

Bethanechol Chloride Compounded Oral Solution (USP38-NF33 2S)

Bethanechol Chloride Compounded Oral Suspension (USP38-NF33 2S)

Cabergoline (USP38-NF33 2S)

Captopril Compounded Oral Solution (USP38-NF33 2S)

Captopril Compounded Oral Suspension (USP38-NF33 2S)

Carbachol (USP38-NF33 2S)

Cefazolin Compounded Ophthalmic Solution (USP38-NF33 2S)

PF 40(5): Sep.-Oct. 2014 4

Chloroquine Phosphate Compounded Oral Suspension (USP38-NF33 2S)

Chlorpheniramine Maleate and Phenylpropanolamine Hydrochloride Extended-Release Capsules

(USP38-NF33 2S)

Chlorpheniramine Maleate and Phenylpropanolamine Hydrochloride Extended-Release Tablets

(USP38-NF33 2S)

Cisapride Compounded Injection, Veterinary [NEW] (USP38-NF33 2S)

Cisapride Compounded Oral Suspension, Veterinary [NEW] (USP38-NF33 2S)

Clemastine Fumarate (USP38-NF33 2S)

Clofazimine (USP38-NF33 2S)

Clofazimine Capsules (USP38-NF33 2S)

Clomiphene Citrate (USP38-NF33 2S)

Clonazepam Compounded Oral Suspension (USP38-NF33 2S)

Clotrimazole Vaginal Inserts (USP38-NF33 2S)

Clotrimazole Lozenges (USP38-NF33 2S)

Cocaine and Tetracaine Hydrochlorides and Epinephrine Compounded Topical Solution (USP38-

NF33 2S)

Codeine Phosphate Compounded Oral Solution (USP38-NF33 2S)

Construct Human Keratinocytes and Fibroblasts in Bovine Collagen Scaffold (USP38-NF33 2S)

Copper Gluconate (USP38-NF33 2S)

Corticotropin Injection (USP38-NF33 2S)

Corticotropin for Injection (USP38-NF33 2S)

Repository Corticotropin Injection (USP38-NF33 2S)

Cyclosporine Compounded Ophthalmic Solution, Veterinary [NEW] (USP38-NF33 2S)

Dalteparin Sodium [NEW] (USP38-NF33 2S)

Dapsone Compounded Oral Suspension (USP38-NF33 2S)

Desmopressin Acetate (USP38-NF33 2S)

Diltiazem Hydrochloride Compounded Oral Solution (USP38-NF33 2S)

Diltiazem Hydrochloride Compounded Oral Suspension (USP38-NF33 2S)

Diphenhydramine and Phenylephrine Hydrochlorides Tablets [NEW] (USP38-NF33 2S)

Diphenhydramine Hydrochloride Oral Solution (USP38-NF33 2S)

Dipyridamole Compounded Oral Suspension (USP38-NF33 2S)

Dolasetron Mesylate Compounded Oral Solution (USP38-NF33 2S)

Dolasetron Mesylate Compounded Oral Suspension (USP38-NF33 2S)

Enalapril Maleate Compounded Oral Suspension (USP38-NF33 2S)

Entecavir [NEW] (USP38-NF33 2S)

Entecavir Tablets [NEW] (USP38-NF33 2S)

Epinephrine Bitartrate (USP38-NF33 2S)

Eszopiclone [NEW] (USP38-NF33 2S)

Ezetimibe [NEW] (USP38-NF33 2S)

Ezetimibe Tablets [NEW] (USP38-NF33 2S)

Famciclovir Compounded Oral Suspension [NEW] (USP38-NF33 2S)

Ferrous Fumarate (USP38-NF33 2S)

Ferrous Gluconate (USP38-NF33 2S)

Ferrous Sulfate (USP38-NF33 2S)

Dried Ferrous Sulfate (USP38-NF33 2S)

Flecainide Acetate Compounded Oral Suspension (USP38-NF33 2S)

Flucytosine Compounded Oral Suspension (USP38-NF33 2S)

Fluorescein (USP38-NF33 2S)

PF 40(5): Sep.-Oct. 2014 5

Fluorescein Sodium (USP38-NF33 2S)

Gonadorelin for Injection (USP38-NF33 2S)

Graftskin (USP38-NF33 2S)

Guanadrel Sulfate (USP38-NF33 2S)

Guanadrel Sulfate Tablets (USP38-NF33 2S)

Insulin Human (USP38-NF33 2S)

Insulin Human Injection (USP38-NF33 2S)

Human Insulin Isophane Suspension and Human Insulin Injection (USP38-NF33 2S)

Isophane Insulin Human Suspension (USP38-NF33 2S)

Insulin Lispro (USP38-NF33 2S)

Insulin Lispro Injection (USP38-NF33 2S)

Insulin Human Zinc Suspension (USP38-NF33 2S)

Extended Insulin Human Zinc Suspension (USP38-NF33 2S)

Lactulose Concentrate (USP38-NF33 2S)

Lactulose Solution (USP38-NF33 2S)

Lamivudine Tablets (USP38-NF33 2S)

Lypressin Nasal Solution (USP38-NF33 2S)

Manganese Gluconate (USP38-NF33 2S)

Marbofloxacin Compounded Oral Suspension, Veterinary [NEW] (USP38-NF33 2S)

Mercaptopurine (USP38-NF33 2S)

Methyltestosterone (USP38-NF33 2S)

Montelukast Sodium Oral Granules [NEW] (USP38-NF33 2S)

Montelukast Sodium Tablets [NEW] (USP38-NF33 2S)

Montelukast Sodium Chewable Tablets [NEW] (USP38-NF33 2S)

Mycophenolate Mofetil Capsules (USP38-NF33 2S)

Mycophenolate Mofetil Tablets (USP38-NF33 2S)

Mycophenolate Sodium [NEW] (USP38-NF33 2S)

Mycophenolic Acid Delayed-Release Tablets [NEW] (USP38-NF33 2S)

Myrrh (USP38-NF33 2S)

Naproxen Sodium and Pseudoephedrine Hydrochloride Extended-Release Tablets [NEW] (USP38-

NF33 2S)

Phenylephrine Hydrochloride Tablets [NEW] (USP38-NF33 2S)

Phenylpropanolamine Bitartrate (USP38-NF33 2S)

Phenylpropanolamine Hydrochloride (USP38-NF33 2S)

Phenylpropanolamine Hydrochloride Capsules (USP38-NF33 2S)

Phenylpropanolamine Hydrochloride Extended-Release Capsules (USP38-NF33 2S)

Phenylpropanolamine Hydrochloride Oral Solution (USP38-NF33 2S)

Phenylpropanolamine Hydrochloride Tablets (USP38-NF33 2S)

Phenylpropanolamine Hydrochloride Extended-Release Tablets (USP38-NF33 2S)

Psyllium Husk (USP38-NF33 2S)

Scaffold Porcine Bladder [NEW] (USP38-NF33 2S)

Scaffold Porcine Small Intestinal Submucosa (USP38-NF33 2S)

Scaffold Silk Fibroin [NEW] (USP38-NF33 2S)

Sennosides (USP38-NF33 2S)

Sodium Nitrite (USP38-NF33 2S)

Sodium Nitrite Injection (USP38-NF33 2S)

Teriparatide Acetate (USP38-NF33 2S)

Thimerosal (USP38-NF33 2S)

PF 40(5): Sep.-Oct. 2014 6

Thyroid (USP38-NF33 2S)

Thyroid Tablets (USP38-NF33 2S)

Wheat Bran (USP38-NF33 2S)

Small Intestinal Submucosa Wound Matrix (USP38-NF33 2S)

Zinc Gluconate (USP38-NF33 2S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

NF MONOGRAPHS

Hydroxyethyl Cellulose

STIMULI TO THE REVISION PROCESS

Stimuli to the Revision Process

Proposed Revisions to General Chapter Sterile Product Packaging - Integrity Evaluation <1207>

PF 40(5): Sep.-Oct. 2014 7

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

USP MONOGRAPHS

Dexamethasone Sodium Phosphate Cream (1-May-2015)

Dexamethasone Sodium Phosphate Injection (1-May-2015)

Dexamethasone Sodium Phosphate Ophthalmic Ointment(1-May-2015)

Dexamethasone Sodium Phosphate Ophthalmic Solution (1-May-2015)

Neomycin Sulfate and Dexamethasone Sodium Phosphate Cream (1-May-2015)

Neomycin Sulfate and Dexamethasone Sodium Phosphate Ophthalmic Ointment (1-May-2015)

Neomycin Sulfate and Dexamethasone Sodium Phosphate Ophthalmic Solution (1-May-2015)

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<503> Acetic Acid in Peptides (USP39-NF34)

<503.1> Trifluoroacetic Acid (TFA) in Peptides [NEW] (USP39-NF34)

<670> Containers - Auxilary Components (USP39-NF34)

<711> Dissolution (USP39-NF34)

<730> Plasma Spectrochemistry (USP39-NF34)

<771> Ophthalmic Ointments (USP39-NF34)

<790> Visible Particulates in Injections (USP39-NF34)

<851> Spectrophotometry and Light-Scattering (USP39-NF34)

<855> Nephelometry, Turbidimetry, and Visual Comparison [NEW] (USP39-NF34)

<858> Raman Spectroscopy [NEW] (USP39-NF34)

<914> Viscosity-Pressure Driven Methods [NEW] (USP39-NF34)

<1120> Raman Spectroscopy (USP39-NF34)

<1251> Weighing On An Analytical Balance (USP39-NF34)

<1661> Evaluation of Plastic Packaging Systems and Their Materials of Construction With

Respect To Their User Safety Impact[NEW] (USP39-NF34)

<1730> Plasma Spectrochemistry - Theory and Practice [NEW] (USP39-NF34)

<1735> X-Ray Fluorescence Spectrometry - Theory and Practice [NEW] (USP39-NF34)

<1771> Ophthalmic Products - Performance Tests (USP39-NF34)

<2040> Disintegration and Dissolution of Dietary Supplements (USP39-NF34)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagents

PF 40(6): Nov.-Dec. 2014 1

Reagent Specifications

2-Pyrrolidone [NEW] (USP39-NF34)

Benzyl Ether [NEW] (USP39-NF34)

Beta-Lactoglobulin [NEW] (USP39-NF34)

Beta-Lactoglobulin A [NEW] (USP39-NF34)

Bromelain (USP39-NF34)

Calcium Citrate (USP39-NF34)

Calcium Sulfate Dihydrate (USP39-NF34)

Chenodeoxycholic Acid (USP39-NF34)

Formic Acid, 98 Percent [NEW] (USP39-NF34)

Lithocholic Acid (USP39-NF34)

Polyoxyethylene 10 Lauryl Ether (USP39-NF34)

Poly(Tetrafluoroethylene) [NEW] (USP39-NF34)

Sodium Ammonium Phosphate Tetrahydrate (USP39-NF34)

Thorium Nitrate (USP39-NF34)

Volumetric Solutions

Edetate Disodium, Tenth-Molar (0.1 M) [NEW] (USP39-NF34)

Silver Nitrate, Tenth-Normal (0.1 N) (USP39-NF34)

Chromatographic Columns

L##_Allantoin, Cosmosil HILIC [NEW] (USP39-NF34)

L##_Ezetimibe, Chiracel OD-RH [NEW] (USP39-NF34)

L##_Rosuvastatin Calcium, CHIRACEL OJ-RH [NEW] (USP39-NF34)

L##_Sodium Nitrite, IonPac AS12A [NEW] (USP39-NF34)

L8 (USP39-NF34)

L10 (USP39-NF34)

L11 (USP39-NF34)

L20 (USP39-NF34)

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets [NEW] (USP39-NF34)

Description and Solubility

Description and Solubility [NEW] (USP39-NF34)

Description and Solubility - A

Description and Solubility - D

Description and Solubility - L

Description and Solubility - P

Description and Solubility - V

DIETARY SUPPLEMENT MONOGRAPHS

Borage Seed Oil (USP39-NF34)

Evening Primrose Oil (USP39-NF34)

Flax Seed Oil (USP39-NF34)

PF 40(6): Nov.-Dec. 2014 2

Ginger (USP39-NF34)

Powdered Ginger (USP39-NF34)

Ginger Tincture (USP39-NF34)

Goldenseal (USP39-NF34)

Powdered Goldenseal (USP39-NF34)

Powdered Goldenseal Extract (USP39-NF34)

Rhodiola rosea Capsules [NEW] (USP39-NF34)

Rhodiola rosea Tablets [NEW] (USP39-NF34)

Ubiquinol Capsules [NEW] (USP39-NF34)

NF MONOGRAPHS

Butylated Hydroxyanisole (USP39-NF34)

USP MONOGRAPHS

Abiraterone Acetate [NEW] (USP39-NF34)

Abiraterone Acetate Tablets [NEW] (USP39-NF34)

Allantoin (USP39-NF34)

Amantadine Hydrochloride Capsules (USP39-NF34)

Amantadine Hydrochloride Oral Solution (USP39-NF34)

Antazoline Phosphate (USP39-NF34)

Aprepitant [NEW] (USP39-NF34)

Aprepitant Capsules [NEW] (USP39-NF34)

Bacitracin (USP39-NF34)

Bacitracin Zinc (USP39-NF34)

Methylene Blue Injection, Veterinary (USP39-NF34)

Calcium Gluconate (USP39-NF34)

Calcium Pantothenate (USP39-NF34)

Cetirizine Hydrochloride Orally Disintegrating Tablets [NEW] (USP39-NF34)

Ciclopirox Cream (USP39-NF34)

Ciclopirox Olamine Cream (USP39-NF34)

Cloxacillin Sodium (USP39-NF34)

Daunorubicin Hydrochloride (USP39-NF34)

Dexmedetomidine Injection [NEW] (USP39-NF34)

Diclofenac Potassium Tablets (USP39-NF34)

Diclofenac Sodium Delayed-Release Tablets (USP39-NF34)

Diclofenac Sodium Extended-Release Tablets (USP39-NF34)

Dicloxacillin Sodium (USP39-NF34)

Doxercalciferol [NEW] (USP39-NF34)

Doxercalciferol Capsules [NEW] (USP39-NF34)

Ephedrine Sulfate Injection (USP39-NF34)

Epinephrine (USP39-NF34)

Eszopiclone Tablets [NEW] (USP39-NF34)

Fluconazole Injection (USP39-NF34)

Fluconazole in Dextrose Injection (USP39-NF34)

Fluconazole in Sodium Chloride Injection [NEW] (USP39-NF34)

PF 40(6): Nov.-Dec. 2014 3

Ganciclovir Oral Suspension (USP39-NF34)

Granisetron Hydrochloride Oral Suspension (USP39-NF34)

Halcinonide (USP39-NF34)

Hydralazine Hydrochloride Oral Solution (USP39-NF34)

Hydrochloric Acid Injection (USP39-NF34)

Indomethacin Topical Gel (USP39-NF34)

Isradipine Oral Suspension (USP39-NF34)

Ketoconazole Oral Suspension (USP39-NF34)

Labetalol Hydrochloride Oral Suspension (USP39-NF34)

Lidocaine Hydrochloride (USP39-NF34)

Lisinopril Oral Suspension (USP39-NF34)

Loratadine Tablets (USP39-NF34)

Lufenuron [NEW] (USP39-NF34)

Meloxicam (USP39-NF34)

Mesalamine (USP39-NF34)

Metolazone Oral Suspension (USP39-NF34)

Metoprolol Tartrate Oral Solution (USP39-NF34)

Metoprolol Tartrate Oral Suspension (USP39-NF34)

Minoxidil Topical Solution (USP39-NF34)

Morphine Sulfate Suppositories (USP39-NF34)

Naratriptan Hydrochloride Oral Suspension (USP39-NF34)

Omeprazole Oral Suspension (USP39-NF34)

Ondansetron Hydrochloride Oral Suspension (USP39-NF34)

Oxacillin Sodium (USP39-NF34)

Paliperidone [NEW] (USP39-NF34)

Pancuronium Bromide Injection (USP39-NF34)

Pantoprazole Oral Suspension (USP39-NF34)

Pentoxifylline Oral Suspension (USP39-NF34)

Pergolide Oral Suspension, Veterinary (USP39-NF34)

Phenobarbital Oral Suspension (USP39-NF34)

Piroxicam Cream (USP39-NF34)

Potassium Bromide Oral Solution, Veterinary (USP39-NF34)

Progesterone Vaginal Suppositories (USP39-NF34)

Propoxyphene Hydrochloride (USP39-NF34)

Propoxyphene Hydrochloride Capsules (USP39-NF34)

Propoxyphene Hydrochloride and Acetaminophen Tablets (USP39-NF34)

Propoxyphene Hydrochloride, Aspirin, and Caffeine Capsules (USP39-NF34)

Propoxyphene Napsylate (USP39-NF34)

Propoxyphene Napsylate Oral Suspension (USP39-NF34)

Propoxyphene Napsylate Tablets (USP39-NF34)

Propoxyphene Napsylate and Acetaminophen Tablets (USP39-NF34)

Propoxyphene Napsylate and Aspirin Tablets (USP39-NF34)

Propylthiouracil Oral Suspension (USP39-NF34)

Pyrazinamide Oral Suspension (USP39-NF34)

Rosuvastatin Tablets [NEW] (USP39-NF34)

Salicylamide (USP39-NF34)

Tolcapone (USP39-NF34)

Tolcapone Tablets (USP39-NF34)

PF 40(6): Nov.-Dec. 2014 4

Vardenafil Hydrochloride [NEW] (USP39-NF34)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

NF MONOGRAPHS

Isomalt

STIMULI TO THE REVISION PROCESS

Stimuli To The Revision Process

Protecting the Quality of Clinical Trial Material During Distribution: What Studies Are Needed and

When?

Use of Enzymes in the Dissolution Testing of Gelatin Capsules and Gelatin-Coated Tablets -

Revisions to Dissolution <711> and Disintegration and Dissolution of Dietary Supplements

<2040>

Ophthalmic Products - Replies to Comments Received

PF 40(6): Nov.-Dec. 2014 5

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

NF MONOGRAPHS

Sesame Oil (1-Jul-2015)

USP MONOGRAPHS

Aluminum Sulfate and Calcium Acetate for Topical Solution (1-Jul-2015)

IN-PROCESS REVISION

IPR Introduction

GENERAL NOTICES AND REQUIREMENTS

General Notices and Requirements (USP39-NF34)

1. Title and Revision (USP39-NF34)

2. Official Status and Legal Recognition (USP39-NF34)

3. Conformance To Standards (USP39-NF34)

4. Monographs and General Chapters (USP39-NF34)

5. Monograph Components (USP39-NF34)

6. Testing Practices and Procedures (USP39-NF34)

7. Test Results (USP39-NF34)

8. Terms and Definitions (USP39-NF34)

9. Prescribing and Dispensing (USP39-NF34)

10. Preservation, Packaging, Storage, and Labeling (USP39-NF34)

GENERAL CHAPTERS

<21> Thermometers (USP39-NF34)

<321> Drug Product Assay Tests - Organic Chemical Medicines [NEW] (USP39-NF34)

<327> Drug Product Impurities Tests [NEW] (USP39-NF34)

<856> Near-Infrared Spectroscopy [NEW] (USP39-NF34)

<1119> Near-Infrared Spectroscopy (USP39-NF34)

<1790> Visual Inspection of Injections [NEW] (USP39-NF34)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

1-Naphthylacetic Acid [NEW] (USP39-NF34)

3-Chloropropane-1,2-Diol [NEW] (USP39-NF34)

PF 41(1): Jan.-Feb. 2015 1

Cupric Nitrate Hydrate (USP39-NF34)

Desmosterol [NEW] (USP39-NF34)

Lathosterol [NEW] (USP39-NF34)

Pregnenolone Isobutyrate [NEW] (USP39-NF34)

Sodium Pentacyanoammineferrate (II) (USP39-NF34)

Triethylammonium Acetate, 1 M [NEW] (USP39-NF34)

Volumetric Solutions

Edetate Disodium, Twentieth-Molar (0.05 M) (USP39-NF34)

Potassium Arsenite, Tenth-Normal (0.1 N) (USP39-NF34)

Potassium Permanganate, Tenth-Normal (0.1 N) (USP39-NF34)

Sodium Thiosulfate, Tenth-Normal (0.1 N) (USP39-NF34)

Chromatographic Columns

L65 (USP39-NF34)

L78 (USP39-NF34)

L88 [NEW] (USP39-NF34)

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets [NEW] (USP39-NF34)

Description and Solubility

Description and Solubility [NEW] (USP39-NF34)

Description and Solubility - E

Description and Solubility - M

Description and Solubility - P

EXCIPIENTS

USP and NF Excipients, Listed by Category [NEW] (USP39-NF34)

Briefing

Introduction

Antimicrobial Preservative

NF MONOGRAPHS

Cholesterol (USP39-NF34)

Ethyl Oleate (USP39-NF34)

Ethylparaben Sodium [NEW] (USP39-NF34)

Sesame Oil (USP39-NF34)

Sodium Starch Glycolate (USP39-NF34)

USP MONOGRAPHS

Amoxapine (USP39-NF34)

PF 41(1): Jan.-Feb. 2015 2

Aripiprazole Tablets [NEW] (USP39-NF34)

Aripiprazole Orally Disintegrating Tablets (USP39-NF34)

Ascorbic Acid Tablets (USP39-NF34)

Aspirin Capsules (USP39-NF34)

Benzocaine Lozenges (USP39-NF34)

Benzocaine and Menthol Topical Aerosol (USP39-NF34)

Brompheniramine Maleate Oral Solution (USP39-NF34)

Brompheniramine Maleate Tablets (USP39-NF34)

Candesartan Cilexetil Tablets [NEW] (USP39-NF34)

Candesartan Cilexetil and Hydrochlorothiazide Tablets [NEW] (USP39-NF34)

Chlorpheniramine Maleate Tablets (USP39-NF34)

Cromolyn Sodium Ophthalmic Solution (USP39-NF34)

Cyanocobalamin Tablets (USP39-NF34)

Daunorubicin Hydrochloride for Injection (USP39-NF34)

Diltiazem Hydrochloride Extended-Release Capsules (USP39-NF34)

Diltiazem Hydrochloride Tablets (USP39-NF34)

Diphenhydramine Hydrochloride Capsules (USP39-NF34)

Diphenhydramine Hydrochloride Injection (USP39-NF34)

Dopamine Hydrochloride (USP39-NF34)

Dopamine Hydrochloride Injection (USP39-NF34)

Enalapril Maleate Tablets (USP39-NF34)

Ephedrine Hydrochloride (USP39-NF34)

Fluticasone Propionate and Salmeterol Inhalation Aerosol [NEW] (USP39-NF34)

Fluticasone Propionate and Salmeterol Inhalation Powder [NEW] (USP39-NF34)

Hard Gelatin Capsule Shell [NEW] (USP39-NF34)

Hydromorphone Hydrochloride (USP39-NF34)

Hydroxyzine Hydrochloride (USP39-NF34)

Hydroxyzine Hydrochloride Injection (USP39-NF34)

Hydroxyzine Hydrochloride Tablets (USP39-NF34)

Ibuprofen Oral Suspension (USP39-NF34)

Ibuprofen Tablets (USP39-NF34)

Iodixanol (USP39-NF34)

Iohexol (USP39-NF34)

Ketorolac Tromethamine Tablets (USP39-NF34)

Memantine Hydrochloride (USP39-NF34)

Methionine (USP39-NF34)

Methocarbamol Injection (USP39-NF34)

Metoprolol Fumarate (USP39-NF34)

Naphazoline Hydrochloride (USP39-NF34)

Nitrofurazone (USP39-NF34)

Orphenadrine Citrate (USP39-NF34)

Orphenadrine Citrate Injection (USP39-NF34)

Orphenadrine Citrate Extended-Release Tablets (USP39-NF34)

Palonosetron Hydrochloride [NEW] (USP39-NF34)

Palonosetron Injection [NEW] (USP39-NF34)

Perindopril Erbumine [NEW] (USP39-NF34)

Perindopril Erbumine Tablets [NEW] (USP39-NF34)

Pyrimethamine Oral Suspension (USP39-NF34)

PF 41(1): Jan.-Feb. 2015 3

Quinidine Sulfate Oral Suspension (USP39-NF34)

Rifabutin Oral Suspension (USP39-NF34)

Rifampin Oral Suspension (USP39-NF34)

Sildenafil Citrate Oral Suspension (USP39-NF34)

Simvastatin Tablets (USP39-NF34)

Sodium Bromide Injection, Veterinary (USP39-NF34)

Sodium Bromide Oral Solution, Veterinary (USP39-NF34)

Sodium Hypochlorite Topical Solution (USP39-NF34)

Sodium Phenylbutyrate Oral Suspension (USP39-NF34)

Sotalol Hydrochloride Oral Suspension (USP39-NF34)

Spironolactone and Hydrochlorothiazide Oral Suspension (USP39-NF34)

Sumatriptan Succinate Oral Suspension (USP39-NF34)

Tacrolimus Oral Suspension (USP39-NF34)

Temozolomide Oral Suspension (USP39-NF34)

Terbinafine Oral Suspension (USP39-NF34)

Terbutaline Oral Suspension (USP39-NF34)

Tetracycline Hydrochloride Oral Suspension (USP39-NF34)

Theophylline Oral Suspension (USP39-NF34)

Tiagabine Hydrochloride Oral Suspension (USP39-NF34)

Tramadol Hydrochloride Oral Suspension (USP39-NF34)

Tramadol Hydrochloride and Acetaminophen Oral Suspension (USP39-NF34)

Triprolidine Hydrochloride (USP39-NF34)

Ursodiol Oral Suspension (USP39-NF34)

Valacyclovir Oral Suspension (USP39-NF34)

Verapamil Hydrochloride Oral Solution (USP39-NF34)

Verapamil Hydrochloride Oral Suspension (USP39-NF34)

Zaleplon

STAGE 4 HARMONIZATION

Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS

Stimuli To The Revision Process

<671> Containers - Performance Testing: Use of Water-Filled Test Containers for Water Vapor

Transmission Rate Determinations

Collaborative Study of the Variability of Drug Release Results from Nicotine Gums using Two

Apparatus Designs

Medicines Marketed under the Food and Drug Administration Over-The-Counter Drug Monograph

System Regulations: Strategy for Developing Compendial Quality Standards

PF 41(1): Jan.-Feb. 2015 4

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<3> Topical and Transdermal Drug Products - Product Quality Tests (USP39-NF34 1S)

<55> Biological Indicators - Resistance Performance Tests (USP39-NF34 1S)

<123> Glucagon Bioidentity Tests (USP39-NF34 1S)

<191> Identification Tests - General (USP39-NF34 1S)

<341> Antimicrobial Agents - Content (USP39-NF34 1S)

<381> Elastomeric Closures for Injections (USP39-NF34 1S)

<507> Protein Determination Procedures [NEW] (USP39-NF34 1S)

<800> Hazardous Drugs - Handling in Healthcare Settings [NEW] (USP39-NF34 1S)

<1050.1> Design, Evaluation, and Characterization of Viral Clearance Procedures [NEW]

(USP39-NF34 1S)

<1176> Prescription Balances and Volumetric Apparatus Used in Compounding (USP39-NF34 1S)

<1229.5> Biological Indicators for Sterilization [NEW] (USP39-NF34 1S)

<1229.9> Physicochemical Integrators and Indicators for Sterilization [NEW] (USP39-NF34 1S)

<1229.12> New Sterilization Methods [NEW] (USP39-NF34 1S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Casein, Hammarsten (USP39-NF34 1S)

Triphenylene [NEW] (USP39-NF34 1S)

Chromatographic Columns

L##_Succinylcholine Chloride, Dionex IonPac CG19 [NEW] (USP39-NF34)

L##_Succinylcholine Chloride, Dionex IonPac CS19 [NEW] (USP39-NF34)

L##_Zorbax SB-Aq [NEW] (USP39-NF34)

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets [NEW] (USP39-NF34 1S)

Description and Solubility of USP and NF Articles

Description and Solubility of USP and NF Articles [NEW] (USP39-NF34 1S)

Description and Solubility - T

PF 41(2): Mar.-Apr. 2015 1

Description and Solubility - Z

DIETARY SUPPLEMENT MONOGRAPHS

Hesperidin [NEW] (USP39-NF34 1S)

Krill Oil (USP39-NF34 1S)

Ribose [NEW] (USP39-NF34 1S)

meso-Zeaxanthin (USP39-NF34 1S)

NF MONOGRAPHS

Guar Gum (USP39-NF34 1S)

USP MONOGRAPHS

Acetaminophen and Caffeine Tablets (USP39-NF34 1S)

Acetylcysteine Compounded Solution [NEW] (USP39-NF34 1S)

Adapalene Gel [NEW] (USP39-NF34 1S)

Alendronate Sodium (USP39-NF34 1S)

Alprazolam Extended-Release Tablets (USP39-NF34 1S)

Aminobenzoate Potassium (USP39-NF34 1S)

Aminobenzoate Sodium (USP39-NF34 1S)

Amitraz (USP39-NF34 1S)

Amitraz Concentrate for Dip (USP39-NF34 1S)

Aripiprazole (USP39-NF34 1S)

Atomoxetine Hydrochloride (USP39-NF34 1S)

Atomoxetine Capsules (USP39-NF34 1S)

Carbamazepine Extended-Release Tablets (USP39-NF34 1S)

Carbidopa and Levodopa Extended-Release Tablets (USP39-NF34 1S)

Carbidopa and Levodopa Orally Disintegrating Tablets (USP39-NF34 1S)

Cefuroxime Axetil (USP39-NF34 1S)

Cefuroxime Axetil Tablets (USP39-NF34 1S)

Cetylpyridinium Chloride (USP39-NF34 1S)

Clemastine Fumarate Tablets (USP39-NF34 1S)

Clomipramine Hydrochloride Compounded Oral Suspension, Veterinary [NEW] (USP39-NF34 1S)

Desloratadine [NEW] (USP39-NF34 1S)

Desloratadine Tablets [NEW] (USP39-NF34 1S)

Desloratadine Orally Disintegrating Tablets [NEW] (USP39-NF34 1S)

Dexchlorpheniramine Maleate Tablets (USP39-NF34 1S)

Dihydroxyaluminum Sodium Carbonate (USP39-NF34 1S)

Diphenhydramine Hydrochloride and Ibuprofen Capsules [NEW] (USP39-NF34 1S)

Docusate Potassium (USP39-NF34 1S)

Dronedarone Hydrochloride [NEW] (USP39-NF34 1S)

Dronedarone Tablets [NEW] (USP39-NF34 1S)

Duloxetine Hydrochloride (USP39-NF34 1S)

Edetate Disodium (USP39-NF34 1S)

Esmolol Hydrochloride (USP39-NF34 1S)

Ethambutol Hydrochloride Compounded Oral Suspension [NEW] (USP39-NF34 1S)

PF 41(2): Mar.-Apr. 2015 2

Etidronate Disodium (USP39-NF34 1S)

Fluorometholone (USP39-NF34 1S)

Glyburide and Metformin Hydrochloride Tablets (USP39-NF34 1S)

Hydralazine Hydrochloride (USP39-NF34 1S)

Hydralazine Hydrochloride Tablets (USP39-NF34 1S)

Hydroxyzine Hydrochloride Oral Solution (USP39-NF34 1S)

Imipramine Hydrochloride Tablets (USP39-NF34 1S)

Indapamide (USP39-NF34 1S)

Indapamide Tablets (USP39-NF34 1S)

Isoleucine (USP39-NF34 1S)

Leucine (USP39-NF34 1S)

Leucovorin Calcium Compounded Oral Suspension [NEW] (USP39-NF34 1S)

Levothyroxine Sodium (USP39-NF34 1S)

Losartan Potassium Tablets (USP39-NF34 1S)

Methylprednisolone (USP39-NF34 1S)

Methylprednisolone Tablets (USP39-NF34 1S)

Miconazole Compounded Ophthalmic Solution [NEW] (USP39-NF34 1S)

Miconazole Nitrate Topical Powder (USP39-NF34 1S)

Phenazopyridine Hydrochloride (USP39-NF34 1S)

Phenazopyridine Hydrochloride Tablets (USP39-NF34 1S)

Rabeprazole Sodium [NEW] (USP39-NF34 1S)

Rimexolone Ophthalmic Suspension (USP39-NF34 1S)

Risedronate Sodium (USP39-NF34 1S)

Salicylic Acid Topical Foam (USP39-NF34 1S)

Sodium Thiosulfate (USP39-NF34 1S)

Sodium Thiosulfate Injection (USP39-NF34 1S)

Succinylcholine Chloride (USP39-NF34 1S)

Sulfamethoxazole and Trimethoprim Oral Suspension (USP39-NF34 1S)

Tacrolimus (USP39-NF34 1S)

Tacrolimus Capsules (USP39-NF34 1S)

Teniposide [NEW] (USP39-NF34 1S)

Teniposide Injection [NEW] (USP39-NF34 1S)

Timolol Maleate Tablets (USP39-NF34 1S)

Triamcinolone Acetonide Nasal Spray [NEW] (USP39-NF34 1S)

Valproic Acid Capsules (USP39-NF34 1S)

Warfarin Sodium (USP39-NF34 1S)

meso-Zeaxanthin Preparation (USP39-NF34 1S)

Zinc Sulfate Compounded Injection [NEW] (USP39-NF34 1S)

Zolmitriptan [NEW] (USP39-NF34 1S)

Zolmitriptan Tablets [NEW] (USP39-NF34 1S)

Zolmitriptan Orally Disintegrating Tablets [NEW] (USP39-NF34 1S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

PF 41(2): Mar.-Apr. 2015 3

USP MONOGRAPHS

Propylene Glycol (USP39-NF34 1S)

STIMULI TO THE REVISION PROCESS

Modernization of Identifications Tests in USP-NF

PF 41(2): Mar.-Apr. 2015 4

Table of Contents

PROPOSED IRA

GENERAL CHAPTERS

<87> BIOLOGICAL REACTIVITY TESTS, IN VITRO (1-Sept-15)

USP MONOGRAPHS

Powdered Digitalis (1-Nov-15)

Digoxin (1-Nov-15)

Omega-3-Acid Ethyl Esters (1-Nov-15)

Omega-3-Acid Ethyl Esters Capsules (1-Nov-15)

Oxycodone Hydrochloride (1-Nov-15)

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<17> PRESCRIPTION CONTAINER LABELING (USP39-NF34 1S)

<476> CONTROL OF ORGANIC IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS (USP39-

NF34 1S)

<659> PACKAGING AND STORAGE REQUIREMENTS (USP39-NF34 1S)

<791> pH (USP39-NF34 1S)

<1035> BIOLOGICAL INDICATORS FOR STERILIZATION (USP39-NF34 1S)

<1058> ANALYTICAL INSTRUMENT QUALIFICATION (USP39-NF34 1S)

<1065> ION CHROMATOGRAPHY (USP39-NF34 1S)

<1086> IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS (USP39-NF34 1S)

<1209> STERILIZATION—CHEMICAL AND PHYSICOCHEMICAL INDICATORS AND INTEGRATORS

(USP39-NF34 1S)

<2251> ADULTERATION OF DIETARY SUPPLEMENTS WITH DRUGS AND DRUG ANALOGS [NEW]

(USP39-NF34 1S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

2,6-Diaminopyridine [NEW] (USP39-NF34 1S)

Benzethonium Chloride [NEW] (USP39-NF34 1S)

Chelating Ion-Exchange Resin [NEW] (USP39-NF34 1S)

Volumetric Solutions

Benzethonium Chloride,Two Hundred Fiftieth-Molar (0.004 M) [NEW] (USP39-NF34 1S)

PF 41(3): May-Jun. 2015 1

Chromatographic Columns

L## (Eptacog Alfa, Dionex CarboPac PA100) [NEW] (USP39-NF34 1S)

L## (Eptacog Alfa, Dionex DNAPac PA100) [NEW] (USP39-NF34 1S)

L## (Metoprolol Succinate, Halo Penta-HILIC) [NEW] (USP39-NF34 1S)

L26 (USP39-NF34 1S)

IN-PROCESS REVISION

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets [NEW] (USP39-NF34 1S)

Description and Solubility

Description and Solubility of USP and NF Articles [NEW] (USP39-NF34 1S)

Description and Solubility - E

Description and Solubility - N

DIETARY SUPPLEMENT MONOGRAPHS

Gamma-Aminobutyric Acid [NEW] (USP39-NF34 1S)

Glutathione (USP39-NF34 1S)

Krill Oil Capsules (USP39-NF34 1S)

Krill Oil Delayed-Release Capsules (USP39-NF34 1S)

NF MONOGRAPHS

Lecithin (USP39-NF34 1S)

USP MONOGRAPHS

Abacavir and Lamivudine Tablets [NEW] (USP39-NF34 1S)

Acetazolamide (USP39-NF34 1S)

Acetazolamide for Injection (USP39-NF34 1S)

Acetazolamide Tablets (USP39-NF34 1S)

Aminophylline (USP39-NF34 1S)

Aminophylline Injection (USP39-NF34 1S)

Aminophylline Oral Solution (USP39-NF34 1S)

Aminophylline Tablets (USP39-NF34 1S)

Argatroban [NEW] (USP39-NF34 1S)

Barium Hydroxide Lime (USP39-NF34 1S)

Biological Indicator for Dry-Heat Sterilization, Paper Carrier (USP39-NF34 1S)

Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier (USP39-NF34 1S)

Biological Indicators for Moist Heat, Dry Heat, and Gaseous Modes of Sterilization, Liquid Spore

Suspensions (USP39-NF34 1S)

Biological Indicators for Moist Heat, Dry Heat, and Gaseous Modes of Sterilization, Nonpaper

Carriers (USP39-NF34 1S)

PF 41(3): May-Jun. 2015 2

Biological Indicator for Steam Sterilization, Paper Carrier (USP39-NF34 1S)

Biological Indicator for Steam Sterilization, Self-Contained (USP39-NF34 1S)

Bisoctrizole (USP39-NF34 1S)

Bupivacaine Hydrochloride (USP39-NF34 1S)

Bupivacaine Hydrochloride Injection (USP39-NF34 1S)

Bupivacaine Hydrochloride in Dextrose Injection (USP39-NF34 1S)

Dantrolene Sodium (USP39-NF34 1S)

Dipyridamole (USP39-NF34 1S)

Dipyridamole Tablets (USP39-NF34 1S)

Eptacog Alfa [NEW] (USP39-NF34 1S)

Eptacog Alfa for Injection [NEW] (USP39-NF34 1S)

Exemestane [NEW] (USP39-NF34 1S)

Fluticasone Propionate Lotion [NEW] (USP39-NF34 1S)

Furosemide (USP39-NF34 1S)

Gemfibrozil Tablets (USP39-NF34 1S)

Interferon beta-1a [NEW] (USP39-NF34 1S)

Interferon beta-1a Injection [NEW] (USP39-NF34 1S)

Iophendylate (USP39-NF34 1S)

Iophendylate Injection (USP39-NF34 1S)

Levamisole Hydrochloride (USP39-NF34 1S)

Levetiracetam (USP39-NF34 1S)

Lithium Carbonate (USP39-NF34 1S)

Medroxyprogesterone Acetate Injectable Suspension (USP39-NF34 1S)

Medroxyprogesterone Acetate Tablets (USP39-NF34 1S)

Mesna (USP39-NF34 1S)

Methylprednisolone Sodium Succinate (USP39-NF34 1S)

Metoprolol Succinate (USP39-NF34 1S)

Metoprolol Succinate Extended-Release Tablets (USP39-NF34 1S)

Oxcarbazepine Tablets (USP39-NF34 1S)

Oxtriphylline Delayed-Release Tablets (USP39-NF34 1S)

Paricalcitol (USP39-NF34 1S)

Paricalcitol Capsules [NEW] (USP39-NF34 1S)

Penicillin G Potassium (USP39-NF34 1S)

Penicillin V Potassium (USP39-NF34 1S)

Sildenafil Tablets [NEW] (USP39-NF34 1S)

Sodium Chloride and Dextrose Tablets (USP39-NF34 1S)

Somatropin (USP39-NF34 1S)

Somatropin for Injection (USP39-NF34 1S)

Succinylcholine Chloride for Injection (USP39-NF34 1S)

Temozolomide (USP39-NF34 1S)

Theophylline (USP39-NF34 1S)

Sterile Purified Water (USP39-NF34 1S)

Sterile Water for Inhalation (USP39-NF34 1S)

Sterile Water for Injection (USP39-NF34 1S)

Sterile Water for Irrigation (USP39-NF34 1S)

STAGE 4 HARMONIZATION

PF 41(3): May-Jun. 2015 3

Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS

Determination of Thermodynamic Solubility of Active Pharmaceutical Ingredients for Veterinary

Species: A New USP General Chapter

Performance Test for Parenteral Dosage Forms

PF 41(3): May-Jun. 2015 4

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

USP MONOGRAPHS

Methocarbamol (1-Jan-2016)

Protamine Sulfate Injection (1-Jan-2016)

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<1130> NUCLEIC ACID-BASED TECHNIQUES—APPROACHES FOR DETECTING TRACE NUCLEIC

ACIDS (RESIDUAL DNA TESTING) (USP39-NF34 2S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Carbon Tetrachloride (USP39-NF34 2S)

4-Hydroxy-4-phenylpiperidine [NEW] (USP39-NF34 2S)

Monosodium Glutamate [NEW] (USP39-NF34 2S)

6Z-Retinoic Acid [NEW] (USP39-NF34 2S)

Sulfaguanidine [NEW] (USP39-NF34 2S)

Chromatographic Columns

L## (Tretinoin, Cosmosil Cholesterol) [NEW] (USP39-NF34 2S)

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets [NEW] (USP39-NF34 2S)

Description and Solubility

Description and Solubility of USP and NF Articles [NEW] (USP39-NF34 2S)

Description and Solubility - C

Description and Solubility - F

Description and Solubility - M

DIETARY SUPPLEMENT MONOGRAPHS

Methylcobalamin Tablets [NEW] (USP39-NF34 2S)

PF 41(4): Jul.-Aug. 2015 1

Northern Schisandra Fruit Dry Extract [NEW] (USP39-NF34 2S)

NF MONOGRAPHS

Chlorobutanol (USP39-NF34 2S)

Eucalyptus Oil (USP39-NF34 2S)

USP MONOGRAPHS

Albuterol Sulfate (USP39-NF34 2S)

Alprazolam Extended-Release Tablets (USP39-NF34 2S)

Alprazolam Orally Disintegrating Tablets (USP39-NF34 2S)

Aminobenzoate Potassium (USP39-NF34 2S)

Aminobenzoate Potassium Capsules (USP39-NF34 2S)

Aminobenzoate Sodium (USP39-NF34 2S)

Gamma-Aminobutyric Acid Capsules [NEW] (USP39-NF34 2S)

Chlordiazepoxide Hydrochloride for Injection (USP39-NF34 2S)

Diatrizoate Sodium (USP39-NF34 2S)

Diclofenac Potassium (USP39-NF34 2S)

Diclofenac Sodium (USP39-NF34 2S)

Doxapram Hydrochloride (USP39-NF34 2S)

Doxapram Hydrochloride Injection (USP39-NF34 2S)

Doxycycline Hyclate Capsules (USP39-NF34 2S)

Doxycycline Hyclate Tablets (USP39-NF34 2S)

Multiple Electrolytes Injection Type 1 (USP39-NF34 2S)

Multiple Electrolytes Injection Type 2 (USP39-NF34 2S)

Multiple Electrolytes and Dextrose Injection Type 1 (USP39-NF34 2S)

Multiple Electrolytes and Dextrose Injection Type 2 (USP39-NF34 2S)

Multiple Electrolytes and Dextrose Injection Type 3 (USP39-NF34 2S)

Multiple Electrolytes and Dextrose Injection Type 4 (USP39-NF34 2S)

Multiple Electrolytes and Invert Sugar Injection Type 1 (USP39-NF34 2S)

Multiple Electrolytes and Invert Sugar Injection Type 2 (USP39-NF34 2S)

Multiple Electrolytes and Invert Sugar Injection Type 3 (USP39-NF34 2S)

Febantel [NEW] (USP39-NF34 2S)

Iopanoic Acid (USP39-NF34 2S)

Iopanoic Acid Tablets (USP39-NF34 2S)

Ipodate Sodium (USP39-NF34 2S)

Ipodate Sodium Capsules (USP39-NF34 2S)

Lisinopril (USP39-NF34 2S)

Mangafodipir Trisodium (USP39-NF34 2S)

Mangafodipir Trisodium Injection (USP39-NF34 2S)

Methotrexate Injection (USP39-NF34 2S)

Methotrexate Tablets (USP39-NF34 2S)

Methylene Blue (USP39-NF34 2S)

Metronidazole Gel (USP39-NF34 2S)

Miconazole Nitrate (USP39-NF34 2S)

Octreotide Acetate (USP39-NF34 2S)

Oxymorphone Hydrochloride Injection (USP39-NF34 2S)

PF 41(4): Jul.-Aug. 2015 2

Oxymorphone Hydrochloride Suppositories (USP39-NF34 2S)

Oxymorphone Hydrochloride Tablets [NEW] (USP39-NF34 2S)

Oxymorphone Hydrochloride Extended-Release Tablets [NEW] (USP39-NF34 2S)

Polyethylene Glycol 3350 (USP39-NF34 2S)

Potassium Chloride in Dextrose Injection (USP39-NF34 2S)

Potassium Chloride in Dextrose and Sodium Chloride Injection (USP39-NF34 2S)

Potassium Chloride in Lactated Ringer's and Dextrose Injection (USP39-NF34 2S)

Potassium Chloride in Sodium Chloride Injection (USP39-NF34 2S)

Promethazine Hydrochloride (USP39-NF34 2S)

Promethazine Hydrochloride Injection (USP39-NF34 2S)

Promethazine Hydrochloride Tablets (USP39-NF34 2S)

Oral Rehydration Salts (USP39-NF34 2S)

Ringer's and Dextrose Injection (USP39-NF34 2S)

Lactated Ringer's Injection (USP39-NF34 2S)

Lactated Ringer's and Dextrose Injection (USP39-NF34 2S)

Half-Strength Lactated Ringer's and Dextrose Injection (USP39-NF34 2S)

Modified Lactated Ringer's and Dextrose Injection (USP39-NF34 2S)

Sodium Nitroprusside (USP39-NF34 2S)

Silver Sulfadiazine (USP39-NF34 2S)

Teriparatide Injection [NEW] (USP39-NF34 2S)

Testosterone (USP39-NF34 2S)

Thiotepa for Injection (USP39-NF34 2S)

Tinidazole (USP39-NF34 2S)

Tretinoin (USP39-NF34 2S)

Tretinoin Cream (USP39-NF34 2S)

Vinblastine Sulfate for Injection (USP39-NF34 2S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS

A Rational Approach to Cascade Impactor Mensuration in a Good Cascade Impactor Practice

Environment

Total Parenteral Nutrition: Position of the USP Elemental Impurities Expert Panel

PF 41(4): Jul.-Aug. 2015 3

Table of Contents

PROPOSED IRA

Proposed IRA Intro Section

USP MONOGRAPHS

Dutasteride (1-Mar-2016)

Methylphenidate Hydrochloride Extended-Release Tablets (1-Mar-2016)

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<1> INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS)—PRODUCT QUALITY TESTS

(USP39-NF34 2S)

<2> ORAL DRUG PRODUCTS—PRODUCT QUALITY TESTS (USP39-NF34 2S)

<3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS—PRODUCT QUALITY TESTS (USP39-NF34

2S)

<4> MUCOSAL DRUG PRODUCTS—PRODUCT QUALITY TESTS (USP39-NF34 2S)

<5> INHALATION AND NASAL DRUG PRODUCTS—GENERAL INFORMATION AND PRODUCT QUALITY

TESTS (USP39-NF34 2S)

<89.1> COLLAGENASE I [NEW] (USP39-NF34 2S)

<89.2> COLLAGENASE II [NEW] (USP39-NF34 2S)

<121.1> PHYSICOCHEMICAL ANALYTICAL PROCEDURES FOR INSULINS (USP39-NF34 2S)

<127> FLOW CYTOMETRIC ENUMERATION OF CD34+ CELLS [NEW] (USP39-NF34 2S)

<212> OLIGOSACCHARIDE ANALYSIS (USP39-NF34 2S)

<467> RESIDUAL SOLVENTS (USP39-NF34 2S)

<771> OPHTHALMIC PRODUCTS—QUALITY TESTS (USP39-NF34 2S)

<782> VIBRATIONAL CIRCULAR DICHROISM SPECTROSCOPY [NEW] (USP39-NF34 2S)

<821> RADIOACTIVITY (USP39-NF34 2S)

<1004> MUCOSAL DRUG PRODUCTS—PERFORMANCE TESTS [NEW] (USP39-NF34 2S)

<1015> AUTOMATED RADIOCHEMICAL SYNTHESIS APPARATUS (USP39-NF34 2S)

<1029> GOOD DOCUMENTATION GUIDELINES (USP39-NF34 2S)

<1063> SHEAR CELL METHODOLOGY FOR POWDER FLOW TESTING [NEW] (USP39-NF34 2S)

<1228.3> DEPYROGENATION BY FILTRATION [NEW] (USP39-NF34 2S)

<1228.5> ENDOTOXIN INDICATORS FOR DEPYROGENATION [NEW] (USP39-NF34 2S)

<1229.13> STERILIZATION-IN-PLACE [NEW] (USP39-NF34 2S)

<1231> WATER FOR PHARMACEUTICAL PURPOSES (USP39-NF34 2S)

<1239> VACCINES FOR HUMAN USE—VIRAL VACCINES [NEW] (USP39-NF34 2S)

<1602> SPACERS AND VALVED HOLDING CHAMBERS USED WITH INHALATION AEROSOLS—

CHARACTERIZATION TESTS (USP39-NF34 2S)

<1782> VIBRATIONAL CIRCULAR DICHROISM SPECTROSCOPY—THEORY AND PRACTICE [NEW]

(USP39-NF34 2S)

PF 41(5): Sep.-Oct. 2015 1

<1821> RADIOACTIVITY—THEORY AND PRACTICE [NEW] (USP39-NF34 2S)

<1823> POSITRON EMISSION TOMOGRAPHY DRUGS—INFORMATION [NEW] (USP39-NF34 2S)

<2040> DISINTEGRATION AND DISSOLUTION OF DIETARY SUPPLEMENTS (USP39-NF34 2S)

<2750> MANUFACTURING PRACTICES FOR DIETARY SUPPLEMENTS (USP39-NF34 2S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

2,2,2-Trichloroethanol (USP39-NF34 2S)

Acetonitrile, Chromatographic [NEW] (USP39-NF34 2S)

Ascorbic Acid [NEW] (USP39-NF34 2S)

Citric Acid (USP39-NF34 2S)

Citric Acid, Anhydrous (USP39-NF34 2S)

4-Cyanopyridine [NEW] (USP39-NF34 2S)

2-Isoniazid [NEW] (USP39-NF34 2S)

Isonicotinamide [NEW] (USP39-NF34 2S)

Methanol, Chromatographic [NEW] (USP39-NF34 2S)

L-Phenylalanine [NEW] (USP39-NF34 2S)

Polyethylene Glycol Standards with Molecular Weights of 1000, 2000, 3000, 4000, and 6000

Daltons (g/mol) [NEW] (USP39-NF34 2S)

Silver Sulfate [NEW] (USP39-NF34 2S)

Test Solutions

10% ASCORBIC ACID TS [NEW] (USP39-NF34 2S)

0.001 N HYDROCHLORIC ACID TS [NEW] (USP39-NF34 2S)

0.06 N HYDROCHLORIC ACID TS (USP39-NF34 2S)

0.36 N HYDROCHLORIC ACID TS [NEW] (USP39-NF34 2S)

2 N HYDROCHLORIC ACID TS [NEW] (USP39-NF34 2S)

3 N HYDROCHLORIC ACID TS [NEW] (USP39-NF34 2S)

6 N HYDROCHLORIC ACID TS [NEW] (USP39-NF34 2S)

0.01 N NITRIC ACID TS [NEW] (USP39-NF34 2S)

0.2 N NITRIC ACID TS [NEW] (USP39-NF34 2S)

1 N NITRIC ACID TS [NEW] (USP39-NF34 2S)

2 N NITRIC ACID TS [NEW] (USP39-NF34 2S)

10% PHOSPHORIC ACID TS [NEW] (USP39-NF34 2S)

2 N POTASSIUM HYDROXIDE TS [NEW] (USP39-NF34 2S)

20% POTASSIUM IODIDE TS [NEW] (USP39-NF34 2S)

0.2 N SODIUM HYDROXIDE TS [NEW] (USP39-NF34 2S)

5 N SODIUM HYDROXIDE TS [NEW] (USP39-NF34 2S)

0.02 N SULFURIC ACID TS [NEW] (USP39-NF34 2S)

6 N SULFURIC ACID TS [NEW] (USP39-NF34 2S)

7 N SULFURIC ACID TS [NEW] (USP39-NF34 2S)

Volumetric Solutions

0.07 N Ferrous Ammonium Sulfate VS [NEW] (USP39-NF34 2S)

0.1 N Hydrochloric Acid VS [NEW] (USP39-NF34 2S)

0.025 N Potassium Dichromate VS [NEW] (USP39-NF34 2S)

PF 41(5): Sep.-Oct. 2015 2

Chromatographic Columns

L90 [NEW] (USP39-NF34 2S)

L91 [NEW] (USP39-NF34 2S)

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets [NEW] (USP39-NF34 2S)

Description and Solubility

Description and Solubility - A

Description and Solubility - D

Description and Solubility - E

Description and Solubility - F

Description and Solubility - M

Description and Solubility - N

Description and Solubility - S

Description and Solubility - T

EXCIPIENTS

USP AND NF EXCIPIENTS, LISTED BY CATEGORY (USP39-NF34 2S)

Briefing

Introduction

Emulsifying Agent

Flavors and Fragrance

USP MONOGRAPHS

Acamprosate Calcium [NEW] (USP39-NF34 2S)

Acetaminophen Suppositories (USP39-NF34 2S)

Albuterol Tablets (USP39-NF34 2S)

Aminohippurate Sodium Injection (USP39-NF34 2S)

Antithrombin III Human (USP39-NF34 2S)

Azelastine Hydrochloride (USP39-NF34 2S)

Betamethasone Valerate Cream (USP39-NF34 2S)

Betamethasone Valerate Lotion (USP39-NF34 2S)

Betamethasone Valerate Ointment (USP39-NF34 2S)

Bismuth Subsalicylate Oral Suspension (USP39-NF34 2S)

Bivalirudin [NEW] (USP39-NF34 2S)

Bivalirudin for Injection [NEW] (USP39-NF34 2S)

Castor Oil (USP39-NF34 2S)

Chlorhexidine Gluconate Topical Gel [NEW] (USP39-NF34 2S)

Chlorothiazide Oral Suspension (USP39-NF34 2S)

Chlorothiazide Tablets (USP39-NF34 2S)

Ciprofloxacin (USP39-NF34 2S)

Ciprofloxacin Hydrochloride (USP39-NF34 2S)

Codeine Sulfate Tablets (USP39-NF34 2S)

PF 41(5): Sep.-Oct. 2015 3

Dolasetron Mesylate Injection (USP39-NF34 2S)

Dolasetron Mesylate Tablets (USP39-NF34 2S)

Doxycycline for Oral Suspension (USP39-NF34 2S)

Epoetin [NEW] (USP39-NF34 2S)

Exenatide [NEW] (USP39-NF34 2S)

Frovatriptan Tablets [NEW] (TBD)

Frovatriptan Succinate [NEW] (TBD)

Guaifenesin (USP39-NF34 2S)

Hydroxyprogesterone Caproate Injection (USP39-NF34 2S)

Imipramine Pamoate Capsules (USP39-NF34 2S)

Insulin Injection (USP39-NF34 2S)

Isophane Insulin Suspension (USP39-NF34 2S)

Insulin Zinc Suspension (USP39-NF34 2S)

Extended Insulin Zinc Suspension (USP39-NF34 2S)

Prompt Insulin Zinc Suspension (USP39-NF34 2S)

Levonorgestrel (USP39-NF34 2S)

Mannitol (USP39-NF34 2S)

Methylergonovine Maleate (USP39-NF34 2S)

Methylnaltrexone Bromide [NEW] (USP39-NF34 2S)

Metronidazole Extended-Release Tablets [NEW] (USP39-NF34 2S)

Miconazole (USP39-NF34 2S)

Mupirocin Calcium (USP39-NF34 2S)

Nebivolol Tablets [NEW] (TBD)

Nebivolol Hydrochloride [NEW] (TBD)

Niacin (USP39-NF34 2S)

Phenol (USP39-NF34 2S)

Promethazine Hydrochloride Oral Solution (USP39-NF34 2S)

Quetiapine Extended-Release Tablets [NEW] (USP39-NF34 2S)

Ropinirole Extended-Release Tablets [NEW] (USP39-NF34 2S)

Solifenacin Succinate [NEW] (TBD)

Sulconazole Nitrate (USP39-NF34 2S)

Sulfisoxazole (USP39-NF34 2S)

Sulfisoxazole Acetyl (USP39-NF34 2S)

Theophylline Oral Solution (USP39-NF34 2S)

Trihexyphenidyl Hydrochloride Tablets (USP39-NF34 2S)

Valproic Acid (USP39-NF34 2S)

Ziprasidone Capsules [NEW] (USP39-NF34 2S)

DIETARY SUPPLEMENT MONOGRAPHS

Ashwagandha Root (USP39-NF34 2S)

Powdered Ashwagandha Root (USP39-NF34 2S)

Powdered Ashwagandha Root Extract (USP39-NF34 2S)

Curcuminoids (USP39-NF34 2S)

Eleuthero (USP39-NF34 2S)

Powdered Eleuthero (USP39-NF34 2S)

Powdered Eleuthero Extract (USP39-NF34 2S)

PF 41(5): Sep.-Oct. 2015 4

Eleuthero Root and Rhizome Dry Extract Capsules [NEW] (USP39-NF34 2S)

Eleuthero Root and Rhizome Dry Extract Tablets [NEW] (USP39-NF34 2S)

Japanese Honeysuckle Flower [NEW] (USP39-NF34 2S)

Japanese Honeysuckle Flower Dry Extract [NEW] (USP39-NF34 2S)

Japanese Honeysuckle Flower Powder [NEW] (USP39-NF34 2S)

Olive Leaf [NEW] (USP39-NF34 2S)

Olive Leaf Dry Extract [NEW] (USP39-NF34 2S)

Olive Leaf Powder [NEW] (USP39-NF34 2S)

Red Clover Aerial Parts Isoflavone Aglycones Dry Extract [NEW] (USP39-NF34 2S)

Powdered Red Clover Extract (USP39-NF34 2S)

Powdered St. John's Wort Extract (USP39-NF34 2S)

Schizochytrium Oil (USP39-NF34 2S)

Turmeric (USP39-NF34 2S)

Powdered Turmeric (USP39-NF34 2S)

Powdered Turmeric Extract (USP39-NF34 2S)

NF MONOGRAPHS

Benzalkonium Chloride Solution (USP39-NF34 2S)

Calcium Propionate (USP39-NF34 2S)

Deoxycholic Acid (USP39-NF34 2S)

Desoxycholic Acid (USP39-NF34 2S)

Hydrogenated Castor Oil (USP39-NF34 2S)

Magnesium Aluminum Silicate (USP39-NF34 2S)

Polyoxyl 35 Castor Oil (USP39-NF34 2S)

Polyoxyl 40 Hydrogenated Castor Oil (USP39-NF34 2S)

Polyvinyl Acetate Dispersion (USP39-NF34 2S)

Potassium Benzoate (USP39-NF34 2S)

Sodium Cetostearyl Sulfate (USP39-NF34 2S)

Sodium Succinate [NEW] (USP39-NF34 2S)

Carnauba Wax (USP39-NF34 2S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

GENERAL CHAPTERS

<644> CONDUCTIVITY OF SOLUTIONS [NEW]

STIMULI TO THE REVISION PROCESS

An Evaluation of the Indifference Zone of the USP <905> Content Uniformity Test

USP Responses to Comments on Stimuli Article Proposed New USP General Information

Chapter:Shear Cell Methodology for Powder Flow Testing <1063>

The Use of Endotoxin as an Analyte in Biopharmaceutical Product Hold Time Studies

PF 41(5): Sep.-Oct. 2015 5

Table of Contents

PROPOSED IRA

Proposed Interim Revision Announcements

USP MONOGRAPHS

Ketorolac Tromethamine (1-May-2016)

IN-PROCESS REVISION

IPR Introduction

GENERAL CHAPTERS

<151> PYROGEN TEST (USP40-NF35)

<481> RIBOFLAVIN ASSAY (USP40-NF35)

<531> THIAMINE ASSAY (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - INTRODUCTION (USP40-

NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - ORGANIZATION OF THIS

CHAPTER (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - RESPONSIBILITY OF

COMPOUNDING PERSONNEL (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - CSP MICROBIAL

CONTAMINATION RISK LEVELS (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - PERSONNEL TRAINING AND

EVALUATION IN ASEPTIC MANIPULATION SKILLS (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - IMMEDIATE-USE CSPs

(USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - SINGLE-DOSE AND

MULTIPLE-DOSE CONTAINERS (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - HAZARDOUS DRUGS AS

CSPs (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - RADIOPHARMACEUTICALS

AS CSPs (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - ALLERGEN EXTRACTS AS

CSPs (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - VERIFICATION OF

COMPOUNDING ACCURACY AND STERILITY (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - ENVIRONMENTAL QUALITY

AND CONTROL (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - SUGGESTED STANDARD

OPERATING PROCEDURES (SOPs) (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - ELEMENTS OF QUALITY

PF 41(6): Nov.-Dec. 2015 1

CONTROL (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - VERIFICATION OF

AUTOMATED COMPOUNDING DEVICES (ACDs) FOR PARENTERAL NUTRITION COMPOUNDING

(USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - FINISHED PREPARATION

RELEASE CHECKS AND TESTS (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - STORAGE AND BEYOND-USE

DATING (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - MAINTAINING STERILITY,

PURITY, AND STABILITY OF DISPENSED AND DISTRIBUTED CSPs (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - PATIENT OR CAREGIVER

TRAINING (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - PATIENT MONITORING AND

ADVERSE EVENTS REPORTING (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - QUALITY ASSURANCE (QA)

PROGRAM (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - ABBREVIATIONS AND

ACRONYMS (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - GLOSSARY (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - APPENDICES (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - 1. INTRODUCTION AND

SCOPE (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - 2. PERSONNEL

QUALIFICATIONS--TRAINING, EVALUATION, AND REQUALIFICATION (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - 3. PERSONAL HYGIENE AND

PERSONAL PROTECTIVE EQUIPMENT (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - 4. BUILDINGS AND

FACILITIES (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - 5. ENVIRONMENTAL

MONITORING (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - 6. CLEANING AND

DISINFECTING COMPOUNDING AREAS (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - 7. EQUIPMENT AND

COMPONENTS (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - 8. STERILIZATION AND

DEPYROGENATION (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - 9. SOPS AND MASTER

FORMULATION AND COMPOUNDING RECORDS (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - 10. RELEASE TESTING

(USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - 11. LABELING (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - 12. ESTABLISHING BEYOND-

USE DATES AND IN-USE TIMES (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - 13. QUALITY ASSURANCE

AND QUALITY CONTROL (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - 14. CSP STORAGE,

HANDLING, PACKAGING, AND TRANSPORT (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - 15. COMPLAINT HANDLING

PF 41(6): Nov.-Dec. 2015 2

AND ADVERSE EVENT REPORTING (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - 16. DOCUMENTATION

(USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - 17.

RADIOPHARMACEUTICALS AS CSPs (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - GLOSSARY (USP40-NF35)

<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS - APPENDICES (USP40-NF35)

<1039> CHEMOMETRICS [NEW] (USP40-NF35)

<1790> VISUAL INSPECTION OF INJECTIONS [NEW] (USP40-NF35)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagents, Indicators and Solutions - Introduction (USP40-NF35)

Reagent Specifications

Copper Sulfate Pentahydrate [NEW] (USP40-NF35)

1,1-Cyclobutanedicarboxylic Acid [NEW] (USP40-NF35)

Hydroxypropyl Cellulose [NEW] (USP40-NF35)

Isonicotinic Acid (USP40-NF35)

Lithium [NEW] (USP40-NF35)

Malonic Acid [NEW] (USP40-NF35)

D-Mannitol [NEW] (USP40-NF35)

Marfey's Reagent [NEW] (USP40-NF35)

Methyl cis-11-Eicosenoate [NEW] (USP40-NF35)

Methyl 12-Ketostearate [NEW] (USP40-NF35)

Nickel Nitrate Hexahydrate [NEW] (USP40-NF35)

Propionic Acid [NEW] (USP40-NF35)

Sodium 1-Dodecanesulfonate [NEW] (USP40-NF35)

Tetrahydrofuran (USP40-NF35)

Water [NEW] (USP40-NF35)

Water, Carbon Dioxide-Free (USP40-NF35)

Water, Deaerated (USP40-NF35)

Water, Organic-Free [NEW] (USP40-NF35)

Water, Particle-Free [NEW] (USP40-NF35)

Test Solutions

2 N Sodium Hydroxide TS [NEW] (USP40-NF35)

1 M Acetic Acid TS [NEW] (USP40-NF35)

2 M Acetic Acid TS [NEW] (USP40-NF35)

1 M Ammonium Hydroxide TS [NEW] (USP40-NF35)

2 M Ammonium Hydroxide TS [NEW] (USP40-NF35)

0.05 N Hydrochloric Acid TS [NEW] (USP40-NF35)

1 N Phosphoric Acid TS [NEW] (USP40-NF35)

1.8 N Potassium Hydroxide TS [NEW] (USP40-NF35)

0.02 M Monobasic Potassium Phosphate TS [NEW] (USP40-NF35)

0.0025 N Sodium Hydroxide TS [NEW] (USP40-NF35)

2.5 N Sodium Hydroxide TS [NEW] (USP40-NF35)

PF 41(6): Nov.-Dec. 2015 3

10 N Sodium Hydroxide TS [NEW] (USP40-NF35)

0.2 N Sulfuric Acid TS [NEW] (USP40-NF35)

0.5 N Sulfuric Acid TS [NEW] (USP40-NF35)

2 N Sulfuric Acid TS [NEW] (USP40-NF35)

Volumetric Solutions

Acetic Acid, Double-Normal (2 N) (USP40-NF35)

Ammonium Thiocyanate, Tenth-Normal (0.1 N) (USP40-NF35)

Bismuth Nitrate, 0.01 M (USP40-NF35)

Bromine, Tenth-Normal (0.1 N) (USP40-NF35)

Ceric Ammonium Nitrate, Twentieth-Normal (0.05 N) (USP40-NF35)

Ceric Sulfate, Tenth-Normal (0.1 N) (USP40-NF35)

Cupric Nitrate, Tenth-Normal (0.1 N) (USP40-NF35)

Cupric Tartrate, Alkaline, Solution (Fehling's Solution) (USP40-NF35)

Edetate Disodium, Twentieth-Molar (0.05 M) (USP40-NF35)

Edetate Disodium, Tenth-Molar (0.1 M) (USP40-NF35)

Ferric Ammonium Sulfate, Tenth-Normal (0.1 N) (USP40-NF35)

Ferrous Ammonium Sulfate, Tenth-Normal (0.1 N) (USP40-NF35)

0.02 N Hydrochloric Acid VS [NEW] (USP40-NF35)

Hydrochloric Acid, Alcoholic, Tenth-Molar (0.1 M) (USP40-NF35)

Hydrochloric Acid, Half-Normal (0.5 N) (USP40-NF35)

Hydrochloric Acid, Half-Normal (0.5 N) in Methanol (USP40-NF35)

Hydrochloric Acid, Normal (1 N) (USP40-NF35)

Iodine, Tenth-Normal (0.1 N) (USP40-NF35)

Iodine, Twentieth-Normal (0.05 N) (USP40-NF35)

Iodine, Hundredth-Normal (0.01 N) (USP40-NF35)

Lead Nitrate, Hundredth-Molar (0.01 M) (USP40-NF35)

Lead Perchlorate, Hundredth-Molar (0.01 M) (USP40-NF35)

Lead Perchlorate, Tenth-Molar (0.1 M) (USP40-NF35)

Lithium Methoxide, Fiftieth-Normal (0.02 N) in Methanol (USP40-NF35)

Lithium Methoxide, Tenth-Normal (0.1 N) in Chlorobenzene (USP40-NF35)

Lithium Methoxide, Tenth-Normal (0.1 N) in Methanol (USP40-NF35)

Lithium Methoxide, Tenth-Normal (0.1 N) in Toluene (USP40-NF35)

Magnesium Chloride, 0.01 M (USP40-NF35)

Mercuric Nitrate, Tenth-Molar (0.1 M) (USP40-NF35)

Oxalic Acid, Tenth-Normal (0.1 N) (USP40-NF35)

Perchloric Acid, Tenth-Normal (0.1 N) in Glacial Acetic Acid (USP40-NF35)

0.05 N Silver Nitrate VS [NEW] (USP40-NF35)

0.1 N Sodium Hydroxide VS [NEW] (USP40-NF35)

Standard Dichlorophenol-Indophenol Solution (USP40-NF35)

0.1 M Zinc Sulfate VS [NEW] (USP40-NF35)

Chromatographic Columns

L19 (USP40-NF35)

L22 (USP40-NF35)

L40 (USP40-NF35)

L45 (USP40-NF35)

L51 (USP40-NF35)

PF 41(6): Nov.-Dec. 2015 4

L54 (USP40-NF35)

L80 (USP40-NF35)

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets [NEW] (USP40-NF35)

Description and Solubility

Description and Solubility of USP and NF Articles [NEW] (USP40-NF35)

Description and Solubility - C

Description and Solubility - P

USP MONOGRAPHS

Acamprosate Delayed-Release Tablets [NEW] (USP40-NF35)

Acetaminophen and Codeine Phosphate Oral Solution (USP40-NF35)

Acetaminophen and Codeine Phosphate Oral Suspension (USP40-NF35)

Albumin Human (USP40-NF35)

Alprazolam Tablets (USP40-NF35)

Amiloxate (USP40-NF35)

Ascorbic Acid Injection (USP40-NF35)

Aspirin (USP40-NF35)

Azathioprine Sodium for Injection (USP40-NF35)

Buprenorphine Hydrochloride (USP40-NF35)

Carboplatin (USP40-NF35)

Carboplatin for Injection (USP40-NF35)

Carglumic Acid [NEW] (USP40-NF35)

Cisplatin (USP40-NF35)

Cisplatin for Injection (USP40-NF35)

Desogestrel [NEW] (USP40-NF35)

Fenbendazole (USP40-NF35)

Fluticasone Propionate Nasal Spray (USP40-NF35)

Hard Gelatin Capsule Shell (USP40-NF35)

Heparin Sodium (USP40-NF35)

Histidine (USP40-NF35)

Hydrocortisone Sodium Succinate (USP40-NF35)

Iodine Topical Solution (USP40-NF35)

Iodine Tincture (USP40-NF35)

Strong Iodine Tincture (USP40-NF35)

Iothalamate Sodium Injection (USP40-NF35)

Iron Sucrose Injection (USP40-NF35)

Ixabepilone [NEW] (USP40-NF35)

Methylprednisolone Acetate (USP40-NF35)

Methylprednisolone Acetate Injectable Suspension (USP40-NF35)

Morphine Sulfate Extended-Release Capsules (USP40-NF35)

Pemetrexed Disodium [NEW] (USP40-NF35)

Pemetrexed for Injection [NEW] (USP40-NF35)

PF 41(6): Nov.-Dec. 2015 5

Penicillin G Procaine (USP40-NF35)

Pentazocine and Acetaminophen Tablets (USP40-NF35)

Phenoxybenzamine Hydrochloride Capsules (USP40-NF35)

Prompt Phenytoin Sodium Capsules (USP40-NF35)

Potassium Gluconate (USP40-NF35)

Potassium Gluconate Oral Solution (USP40-NF35)

Potassium Gluconate Tablets (USP40-NF35)

Pregabalin [NEW] (USP40-NF35)

Pseudoephedrine Sulfate (USP40-NF35)

Riboflavin Tablets (USP40-NF35)

Ringer's Injection (USP40-NF35)

Secobarbital Sodium Injection (USP40-NF35)

Secobarbital Sodium for Injection (USP40-NF35)

Secobarbital Sodium and Amobarbital Sodium Capsules (USP40-NF35)

Selamectin [NEW] (USP40-NF35)

Sodium Citrate and Citric Acid Oral Solution (USP40-NF35)

Sulfadoxine and Pyrimethamine Tablets (USP40-NF35)

Testosterone Topical Gel [NEW] (USP40-NF35)

Tetrahydrozoline Hydrochloride (USP40-NF35)

Thiamine Hydrochloride Tablets (USP40-NF35)

DIETARY SUPPLEMENT MONOGRAPHS

Citrulline [NEW] (USP40-NF35)

Creatine [NEW] (USP40-NF35)

Rutin (USP40-NF35)

Sodium Ferrous Citrate [NEW] (USP40-NF35)

Tienchi Ginseng Root and Rhizome Dry Extract Capsules [NEW] (USP40-NF35)

Tienchi Ginseng Root and Rhizome Dry Extract Tablets [NEW] (USP40-NF35)

Tienchi Ginseng Root and Rhizome Powder Capsules [NEW] (USP40-NF35)

Tienchi Ginseng Root and Rhizome Powder Tablets [NEW] (USP40-NF35)

NF MONOGRAPHS

Tribasic Calcium Phosphate (USP40-NF35)

Croscarmellose Sodium (USP40-NF35)

Monosodium Glutamate (USP40-NF35)

Potassium Hydroxide (USP40-NF35)

STAGE 4 Harmonization

Harmonization Introduction Stage 4

STIMULI TO THE REVISION PROCESS

Stimuli Introduction

Guideline for Assigning Titles to USP Dietary Supplements Monographs

PF 41(6): Nov.-Dec. 2015 6

Pharmacopieal Forum Vol. 42(1) [Jan–Feb 2016] 1

Table of Contents

Journal of Standards Development ........................................................... 5

Pharmacopeial Forum’s Public Review and Comment Process ........................................ 7

How to Use PF ........................................................................... 8

Proposed IRA

Proposed Interim Revision Announcements .................................................... 11

USP Monographs

Ceftriaxone Sodium ..................................................................... 13

Ceftriaxone for Injection .................................................................. 14

Cisatracurium Besylate ................................................................... 16

Corticotropin Injection ................................................................... 18

Corticotropin for Injection ................................................................. 20

Repository Corticotropin Injection ........................................................... 22

Protamine Sulfate ....................................................................... 24

Protamine Sulfate Injection ................................................................ 26

NF Monographs

Glyceryl Tristearate ...................................................................... 28

In-Process Revision

In-Process Revision Introduction ............................................................ 31

General Notices and Requirements

General Notices to USP-NF ................................................................ 33

General Chapters

〈670〉 Containers—Auxiliary Packaging Components ............................................. 45

Reagents, Indicators, and Solutions

Reagents ............................................................................. 53

Butylated Hydroxytoluene ................................................................. 53

Deschloroclotrimazole .................................................................... 53

Paired Ion Chromatography Reagent ........................................................ 53

0.06 M Phosphoric Acid TS ................................................................ 51

Polysorbate 80 ......................................................................... 53

Tetrabutylammonium Hydroxide 30-Hydrate ................................................... 53

Cupric Nitrate .......................................................................... 54

Test Solutions

0.01 M Edetate Disodium TS .............................................................. 54

0.01 N Hydrochloric Acid TS ............................................................... 54

0.025 N Hydrochloric Acid TS .............................................................. 54

20% Phosphoric Acid TS .................................................................. 54

0.05 M Phosphoric Acid TS ................................................................ 54

45% Potassium Hydroxide TS .............................................................. 54

0.2 M Dibasic Potassium Phosphate TS ....................................................... 54

2 Pharmacopieal Forum Vol. 42(1) [Jan–Feb 2016]

0.02 N Sodium Hydroxide TS .............................................................. 55

1 M Sulfuric Acid TS ..................................................................... 55

0.02 M Tetrabutylammonium Hydrogen Sulfate TS .............................................. 55

Volumetric Solutions

0.1 N Potassium Thiocyanate VS ............................................................ 55

0.1 N Perchloric Acid In Dioxane VS ......................................................... 55

0.1 N Potassium Arsenite VS ............................................................... 56

0.1 N Potassium Bromate VS .............................................................. 56

0.1 N Potassium Bromide—Bromate VS ...................................................... 56

0.1 N Potassium Dichromate VS ............................................................ 56

0.05 M Potassium Ferricyanide VS ........................................................... 57

0.5 N Alcoholic Potassium Hydroxide VS ...................................................... 57

0.1 M Alcoholic Potassium Hydroxide VS ..................................................... 57

0.1 N Methanolic Potassium Hydroxide VS .................................................... 57

1 N Potassium Hydroxide VS ............................................................... 58

0.05 M Potassium Iodate VS ............................................................... 58

0.1 N Potassium Permanganate VS .......................................................... 58

0.1 N Silver Nitrate VS ................................................................... 58

0.002 N Silver Nitrate In Isopropyl Alcohol VS ................................................. 59

0.05 M Sodium Arsenite VS ............................................................... 59

1 N Sodium Hydroxide VS ................................................................ 59

0.1 N Alcoholic Sodium Hydroxide VS ....................................................... 59

0.5 N Sodium Methoxide In Methanol VS ..................................................... 60

0.1 N Sodium Methoxide In Toluene VS ...................................................... 60

0.1 M Sodium Nitrite VS .................................................................. 60

0.02 M Sodium Tetraphenylboron VS ........................................................ 61

0.1 N Sodium Thiosulfate VS .............................................................. 61

1 N Sulfuric Acid VS ..................................................................... 61

0.5 N Sulfuric Acid In Alcohol VS ........................................................... 62

0.1 N Tetrabutylammonium Hydroxide VS .................................................... 62

0.1 N Tetrabutylammonium Hydroxide In Methanol/Isopropyl Alcohol VS ............................. 62

0.1 M Tetramethylammonium Bromide VS .................................................... 63

0.1 M Tetramethylammonium Chloride VS .................................................... 63

0.1 N Titanium Trichloride VS .............................................................. 63

0.05 M Zinc Sulfate VS ................................................................... 64

Chromatographic Columns

L56 .................................................................................. 64

Reference Tables

Container Specifications .................................................................. 65

Description and Solubility ................................................................. 66

USP Monographs

Acebutolol Hydrochloride Capsules .......................................................... 67

Acetaminophen, Chlorpheniramine Maleate, and Dextromethorphan Hydrobromide Tablets ............... 69

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Pseudoephedrine

Hydrochloride Oral Solution ............................................................. 71

Acetaminophen and Diphenhydramine Citrate Tablets ........................................... 73

Acetaminophen, Diphenhydramine Hydrochloride, and Pseudoephedrine Hydrochloride Tablets ............ 74

Acetaminophen and Pseudoephedrine Hydrochloride Tablets ...................................... 76

Acetaminophen and Tramadol Hydrochloride Tablet ............................................. 77

Pharmacopieal Forum Vol. 42(1) [Jan–Feb 2016] 3

Aminophylline .......................................................................... 80

Amlodipine and Atorvastatin Tablets ......................................................... 83

Atazanavir Sulfate ....................................................................... 87

Atazanavir Capsules ..................................................................... 89

Atorvastatin Calcium Tablets ............................................................... 92

Biperiden ............................................................................. 95

Biperiden Hydrochloride .................................................................. 96

Biperiden Hydrochloride Tablets ............................................................ 97

Biperiden Lactate Injection ................................................................ 98

Cidofovir .............................................................................. 99

Cidofovir Injection ..................................................................... 100

Ciprofloxacin Tablets .................................................................... 102

Cromolyn Sodium ...................................................................... 103

Cysteine Hydrochloride .................................................................. 106

Dalfampridine ......................................................................... 107

Demeclocycline Hydrochloride Tablets ...................................................... 109

Desipramine Hydrochloride Tablets ......................................................... 112

Desoximetasone ....................................................................... 112

Desoximetasone Cream ................................................................. 113

Desoximetasone Gel .................................................................... 114

Desoximetasone Ointment ............................................................... 115

Doxercalciferol ........................................................................ 116

Hydroxyzine Hydrochloride ............................................................... 118

Hydroxyzine Hydrochloride Oral Solution .................................................... 120

Hydroxyzine Pamoate ................................................................... 122

Hydroxyzine Pamoate Capsules ............................................................ 125

Ibuprofen Oral Suspension ............................................................... 127

Iloperidone ........................................................................... 130

Indomethacin Oral Suspension ............................................................ 132

Isoflurane ............................................................................ 134

Methylene Blue Injection ................................................................. 137

Metoprolol Tartrate Injection .............................................................. 139

Moxifloxacin Hydrochloride .............................................................. 141

Moxifloxacin Tablets .................................................................... 143

Nicotine Polacrilex ..................................................................... 145

Norethindrone ........................................................................ 148

Norethindrone Tablets .................................................................. 150

Norethindrone Acetate .................................................................. 153

Norethindrone Acetate Tablets ............................................................ 156

Olopatadine Hydrochloride ............................................................... 159

Olopatadine Hydrochloride Ophthalmic Solution .............................................. 161

Pimobendan .......................................................................... 162

Polymyxin B Sulfate .................................................................... 164

Potassium Citrate Extended-Release Tablets ................................................... 166

Prochlorperazine Maleate ................................................................ 168

Sodium Hypochlorite Solution ............................................................. 170

Spironolactone ........................................................................ 171

Silver Sulfadiazine Cream ................................................................ 173

Tissue Human Amnion Chorion Membrane Dehydrated ......................................... 175

Tranexamic Acid Injection ................................................................ 177

Tramadol Hydrochloride and Acetaminophen Tablets ........................................... 178

Tretinoin Gel .......................................................................... 181

Ziprasidone Hydrochloride ............................................................... 182

4 Pharmacopieal Forum Vol. 42(1) [Jan–Feb 2016]

Dietary Supplement Monographs

Cinnamomum cassia Twig ............................................................... 187

Cinnamomum cassia Twig Powder ......................................................... 189

Crypthecodinium cohnii Oil .............................................................. 191

St. John’s Wort ........................................................................ 193

St. John’s Wort Flowering Tops Dry Extract Capsules ............................................ 195

St. John’s Wort Flowering Tops Dry Extract Tablets ............................................. 197

Powdered St. John’s Wort ................................................................ 198

Powdered St. John’s Wort Extract .......................................................... 200

Salix Species Bark ...................................................................... 202

Salix Species Bark Dry Extract ............................................................. 204

Salix Species Bark Powder ................................................................ 206

Stage 4 Harmonization

Stage 4 Harmonization .................................................................. 209

General Chapters

〈1061〉 Color—Instrumental Measurement .................................................... 211

Stimuli to the Revision Process

Stimuli to The Revision Process ............................................................ 217

The Advisability and Feasibility of Developing USP Standards for Medical Cannabis ..................... 219

Pharmacopeial Forum Vol. 42(2) [Mar.–Apr. 2016] i

Table of Contents

Journal of Standards Development ........................................................... 1

Pharmacopeial Forum’s Public Review and Comment Process ........................................ 3

How to Use PF ........................................................................... 5

Proposed IRA

Proposed Interim Revision Announcements Introduction ........................................... 7

USP Monographs

Asparatic Acid (1-Sep-2016) ................................................................ 9

Levothyroxine Sodium Tablets (1-Sep-2016) ................................................... 10

Liothyronine Sodium (1-Sep-2016) .......................................................... 12

Tamsulosin Hydrochloride (1-Sep-2016) ...................................................... 13

In-Process Revision

In-Process Revision Introduction ............................................................ 17

General Chapters

〈210〉 Monosaccharide Analysis [NEW] (1

Supp to USP 40) ....................................... 19

〈232〉 Elemental Impurities—Limits (1

Supp to USP 40) .......................................... 24

〈856〉 Near-Infrared Spectroscopy [NEW] (1

Supp to USP 40) ..................................... 29

〈858〉 Raman Spectroscopy [NEW] (1

Supp to USP 40) .......................................... 34

〈1120〉 Raman Spectroscopy (1

Supp to USP 40) ............................................... 38

〈1171〉 Phase-Solubility Analysis (1

Supp to USP 40) ............................................ 51

〈1225〉 Validation of Compendial Procedures (1

Supp to USP 40) .................................. 53

Reagents, Indicators, and Solutions

Reagent Specifications .................................................................. 59

Bacterial Alkaline Protease Preparation (1

Supp to USP 40) ....................................... 59

(S)-Binol [NEW] (1

Supp to USP 40) ........................................................ 59

2,6-Dichloroquinone-chlorimide (1

Supp to USP 40) ............................................ 59

Ether, Peroxide-Free (1

Supp to USP 40) ..................................................... 59

Filter Paper, Quantitative (1

Supp to USP 40) ................................................. 60

Guaifenesin (1

Supp to USP 40) ........................................................... 60

5-Hydroxymethylfurfural [NEW] (1

Supp to USP 40) ............................................ 60

Montelukast Sodium Hydrate [NEW] (1

Supp to USP 40) ........................................ 60

Pepsin (1

Supp to USP 40) ............................................................... 60

Propylparaben (1

Supp to USP 40) ......................................................... 62

Silicotungstic Acid, n-Hydrate (1

Supp to USP 40) .............................................. 62

Sodium 1-Hexanesulfonate Monohydrate (1

Supp to USP 40) ..................................... 62

Tosylchloramide Sodium [NEW] (1

Supp to USP 40) ............................................ 62

Xylometazoline Hydrochloride [NEW] (1

Supp to USP 40) ........................................ 62

Volumetric Solutions .................................................................... 62

0.1 N Hydrochloric Acid VS (1

Supp to USP 40) ............................................... 62

ii Pharmacopeial Forum Vol. 42(2) [Mar.–Apr. 2016]

Chromatographic Columns ............................................................... 63

L91 [NEW] (1

Supp to USP 40) ............................................................ 63

L99 [NEW] (1

Supp to USP 40) ............................................................ 63

Reference Tables

Container Specifications [NEW] (1

Supp to USP 40) ............................................ 64

Description and Solubility [NEW] (1

Supp to USP 40) ........................................... 65

USP Monographs

Acetaminophen Tablets (1

Supp to USP 40) .................................................. 66

Aloe (1

Supp to USP 40) ................................................................. 68

Belladonna Leaf (1

Supp to USP 40) ........................................................ 69

Cabergoline Tablets (1

Supp to USP 40) ..................................................... 71

Carbinoxamine Maleate (1

Supp to USP 40) .................................................. 73

Carbinoxamine Maleate Tablets (1

Supp to USP 40) ............................................ 75

Ciprofloxacin for Oral Suspension [NEW] (1

Supp to USP 40) ..................................... 77

Clonazepam Orally Disintegrating Tablets (1

Supp to USP 40) ..................................... 79

Darifenacin Hydrobromide [NEW] (1

Supp to USP 40) ........................................... 81

Dexamethasone Topical Aerosol (1

Supp to USP 40) ............................................ 83

Dexamethasone Gel (1

Supp to USP 40) ..................................................... 83

Digitalis (1

Supp to USP 40) .............................................................. 84

Doxycycline (1

Supp to USP 40) ........................................................... 85

Doxycycline Capsules (1

Supp to USP 40) .................................................... 88

Doxycycline Tablets (1

Supp to USP 40) ..................................................... 91

Doxycycline Hyclate (1

Supp to USP 40) ..................................................... 93

Esomeprazole Strontium [NEW] (1

Supp to USP 40) ............................................ 96

Estradiol Valerate (1

Supp to USP 40) ....................................................... 98

Flecainide Acetate (1

Supp to USP 40) ...................................................... 101

Flecainide Acetate Tablets (1

Supp to USP 40) ................................................ 103

Indomethacin for Injection (1

Supp to USP 40) ............................................... 106

Ipecac (1

Supp to USP 40) .............................................................. 107

Leuprolide Acetate (1

Supp to USP 40) ..................................................... 109

Loratadine Oral Solution (1

Supp to USP 40) ................................................. 112

Loratadine Tablets (1

Supp to USP 40) ..................................................... 114

Methionine (1

Supp to USP 40) .......................................................... 115

Methyldopa (1

Supp to USP 40) .......................................................... 118

Myrrh (1

Supp to USP 40) ............................................................... 120

Nicotine Transdermal System (1

Supp to USP 40) ............................................. 121

Nilutamide [NEW] (1

Supp to USP 40) ..................................................... 125

Nitrofurazone (1

Supp to USP 40) ......................................................... 126

Paricalcitole Capsules [NEW] (1

Supp to USP 40) .............................................. 128

Plantago Seed (1

Supp to USP 40) ........................................................ 130

Podophyllum (1

Supp to USP 40) ......................................................... 131

Prednisone (1

Supp to USP 40) ........................................................... 132

Promethazine Hydrochloride Suppositories (1

Supp to USP 40) ................................... 134

Rauwolfia Serpentina (1

Supp to USP 40) ................................................... 136

Senna Leaf (1

Supp to USP 40) ........................................................... 138

Senna Pods (1

Supp to USP 40) .......................................................... 139

Storax (1

Supp to USP 40) .............................................................. 140

Theophylline Extended-Release Capsules (1

Supp to USP 40) ..................................... 141

Timolol Maleate (1

Supp to USP 40) ....................................................... 145

Tizanidine Tablets (1

Supp to USP 40) ...................................................... 147

Tobramycin (1

Supp to USP 40) .......................................................... 149

Pharmacopeial Forum Vol. 42(2) [Mar.–Apr. 2016]

iii

Tripelennamine Hydrochloride (1

Supp to USP 40) ........................................... . 151

Witch Hazel (1

Supp to USP 40) ......................................................... . 152

Zaleplon Capsules (1

Supp to USP 40) .................................................... . 153

Zolpidem Tartrate (1

Supp to USP 40)..................................................... . 156

Dietary Supplement Monographs

Ashwagandha Root (1

Supp to USP 40) ................................................... . 158

Powdered Ashwagandha Root (1

Supp to USP 40) ........................................... . 161

Powdered Ashwagandha Root Extract (1

Supp to USP 40)...................................... . 164

Cascara Sagrada (1

Supp to USP 40)...................................................... . 168

Chia Seed Oil [NEW] (1

Supp to USP 40) .................................................. . 170

Coffee Fruit Dry Extract [NEW] (1

Supp to USP 40) ........................................... . 171

Eleuthero Root and Rhizome Powder Capsules [NEW] (1

Supp to USP 40) ......................... . 173

Lactobacillus paracasei LPC-37 [NEW] (1

Supp to USP 40) ...................................... . 175

Lactobacillus rhamnosus HN001 [NEW] (1

Supp to USP 40) ..................................... . 176

Lactobacillus acidophilus La-14 [NEW] (1

Supp to USP 40) ...................................... . 178

Lactobacillus acidophilus NCFM [NEW] (1

Supp to USP 40) ..................................... . 180

Plant Stanol Esters [NEW] (1

Supp to USP 40) ............................................... . 182

Excipients

USP and NF Excipients, Listed by Category .................................................. . 185

NF Monographs

Caraway (1

Supp to NF 35)............................................................. . 186

Cardamom Seed [NEW] (1

Supp to NF 35) ................................................. . 186

Chocolate (1

Supp to NF 35) ........................................................... . 187

Cholesterol (1

Supp to NF 35) .......................................................... . 187

Sodium Lauroyl Sarcosinate (1

Supp to NF 35) ............................................. . 190

Vanilla (1

Supp to NF 35) .............................................................. . 193

White Wax (1

Supp to NF 35) .......................................................... . 194

Yellow Wax (1

Supp to NF 35) .......................................................... . 195

Stage 4 Harmonization

Stage 4 Harmonization Introduction....................................................... . 197

Stimuli to the Revision Process

Stimuli to the Revision Process Introduction ................................................. . 199

Evaluation of USP Melting Point Standards by Differential Scanning Calorimetry ...................... . 201

Fitness for Use: Decision Rules and Target Measurement Uncertainty............................... . 207

Need for Clear Regulation of Pesticide Residue Limits for Articles of Botanical Origin................... . 217

Pharmacopeial Forum Vol. 42(3) [May–June 2016] i

Table of Contents

Journal of Standards Development ........................................................... 1

Pharmacopeial Forum’s Public Review and Comment Process ........................................ 3

How to Use PF ........................................................................... 5

Proposed IRA

Proposed Interim Revision Announcements Introduction ........................................... 7

USP Monographs

Insulin Glargine (1-Nov-2016) ............................................................... 9

Insulin Glargine Injection (1-Nov-2016) ....................................................... 12

Pimozide (1-Nov-2016) ................................................................... 14

Pimozide Tablets (1-Nov-2016) ............................................................. 15

In-Process Revision

In-Process Revision Introduction ............................................................ 19

General Chapters

〈126〉 Somatropin Bioidentity Tests (USP40-NF35 1S) ............................................ 21

〈371〉 Cobalamin Radiotracer Assay (USP40-NF35 1S) ............................................ 23

〈621〉 Chromatography (USP40-NF35 1S) ..................................................... 24

〈661.3〉 Plastic Components and Systems Used in Pharmaceutical Manufacturing [NEW] (USP40-NF35 1S) .... 35

〈1058〉 Analytical Instrument Qualification [NEW] (USP40-NF35 1S) ................................. 40

〈1661〉 Evaluation of Plastic Packaging Systems and Their Materials of Construction with Respect to Their User

Safety Impact [NEW] (USP40-NF35 1S) ....................................................... 49

Reagents, Indicators, and Solutions

Reagent Specifications .................................................................. 66

Acetaldehyde Ammonia Trimer Trihydrate [NEW] (USP40-NF35 1S) ................................. 66

2-Chlorobenzophenone [NEW] (USP40-NF35 1S) ............................................... 66

1-Chloro-4-Nitrobenzene [NEW] (USP40-NF35 1S) .............................................. 66

Ethylparaben [NEW] (USP40-NF35 1S) ....................................................... 66

Lactic Acid [NEW] (USP40-NF35 1S) ......................................................... 66

-Methionine Sulfoxide [NEW] (USP40-NF35 1S) ................................................ 66

1-Methylimidazole [NEW] (USP40-NF35 1S) ................................................... 66

2-Methylimidazole [NEW] (USP40-NF35 1S) ................................................... 67

1-Naphthol (USP40-NF35 1S) .............................................................. 67

Resorcinol [NEW] (USP40-NF35 1S) ......................................................... 67

Tyrosol [NEW] (USP40-NF35 1S) ............................................................ 67

Test Solutions ......................................................................... 67

0.01% Phosphoric Acid TS [NEW] (USP40-NF35 1S) ............................................. 67

0.02 M Phosphoric Acid TS [NEW] (USP40-NF35 1S) ............................................ 67

Volumetric Solutions .................................................................... 67

0.05 N Sulfuric Acid VS [NEW] (USP40-NF35 1S) ............................................... 67

ii Pharmacopeial Forum Vol. 42(3) [May–June 2016]

Reference Tables

Container Specifications [NEW] (USP40-NF35 1S) ............................................... 69

Description and Solubility (USP40-NF35 1S) ................................................... 70

USP Monographs

Acetaminophen Tablets (USP40-NF35 1S) ..................................................... 71

Acetaminophen and Codeine Phosphate Capsules (USP40-NF35 1S) ................................. 72

Acetaminophen and Codeine Phosphate Tablets (USP40-NF35 1S) .................................. 74

Acetohexamide (USP40-NF35 1S) ........................................................... 75

Acetohexamide Tablets (USP40-NF35 1S) ..................................................... 76

Amoxicillin (USP40-NF35 1S) .............................................................. 77

Benzocaine, Butamben, and Tetracaine Hydrochloride Topical Aerosol (USP40-NF35 1S) .................. 79

Benzocaine, Butamben, and Tetracaine Hydrochloride Gel (USP40-NF35 1S) ........................... 81

Benzocaine, Butamben, and Tetracaine Hydrochloride Topical Solution (USP40-NF35 1S) ................. 84

Buprenorphine and Naloxone Sublingual Tablets [NEW] (USP40-NF35 1S) ............................ 86

Butamben (USP40-NF35 1S) ............................................................... 88

Carisoprodol Tablets (USP40-NF35 1S) ....................................................... 90

Clavulanate Potassium (USP40-NF35 1S) ...................................................... 92

Clomipramine Hydrochloride (USP40-NF35 1S) ................................................. 95

Clomipramine Hydrochloride Capsules (USP40-NF35 1S) ......................................... 97

Clotrimazole (USP40-NF35 1S) ............................................................ 100

Clotrimazole Cream (USP40-NF35 1S) ...................................................... 102

Cyproheptadine Hydrochloride (USP40-NF35 1S) .............................................. 104

Cyproheptadine Hydrochloride Oral Solution (USP40-NF35 1S) .................................... 106

Cyproheptadine Hydrochloride Tablets (USP40-NF35 1S) ........................................ 108

Doxycycline for Injection (USP40-NF35 1S) ................................................... 110

Doxylamine Succinate (USP40-NF35 1S) ..................................................... 113

Doxylamine Succinate Tablets (USP40-NF35 1S) ............................................... 115

Eprosartan Mesylate [NEW] (USP40-NF35 1S) ................................................. 117

Esmolol Hydrochloride (USP40-NF35 1S) ..................................................... 119

Etidronate Disodium (USP40-NF35 1S) ...................................................... 121

Etidronate Disodium Tablets (USP40-NF35 1S) ................................................ 123

Etomidate (USP40-NF35 1S) .............................................................. 125

Etomidate Injection (USP40-NF35 1S) ....................................................... 126

Ezetimibe Tablets (USP40-NF35 1S) ......................................................... 128

Flumazenil Injection (USP40-NF35 1S) ...................................................... 129

Gluconolactone (USP40-NF35 1S) .......................................................... 131

Goserelin Implants [NEW] (USP40-NF35 1S) .................................................. 132

Idarubicin Hydrochloride Injection (USP40-NF35 1S) ............................................ 136

Indomethacin Sodium (USP40-NF35 1S) ..................................................... 137

Lindane (USP40-NF35 1S) ................................................................ 140

Lindane Lotion (USP40-NF35 1S) .......................................................... 142

Lindane Shampoo (USP40-NF35 1S) ........................................................ 144

Lorazepam Oral Concentrate (USP40-NF35 1S) ................................................ 146

Metoprolol Tartrate Tablets (USP40-NF35 1S) ................................................. 147

Naloxone Hydrochloride Injection (USP40-NF35 1S) ............................................ 150

Nevirapine Extended Release Tablets [NEW] (USP40-NF35 1S) .................................... 151

Olmesartan Medoxomil Tablets [NEW] (USP40-NF35 1S) ........................................ 153

Ondansetron Orally Disintegrating Tablets (USP40-NF35 1S) ...................................... 155

Pentazocine Hydrochloride (USP40-NF35 1S) ................................................. 157

Potassium Chloride Extended-Release Tablets (USP40-NF35 1S) .................................... 159

Ramipril Tablets [NEW] (USP40-NF35 1S) .................................................... 160

Salmeterol Xinafoate (USP40-NF35 1S) ...................................................... 162

Pharmacopeial Forum Vol. 42(3) [May–June 2016] iii

Scopolamine Hydrobromide (USP40-NF35 1S) ................................................ 164

Theophylline In Dextrose Injection (USP40-NF35 1S) ........................................... 166

Venlafaxine Tablets (USP40-NF35 1S) ....................................................... 169

Dietary Supplement Monographs

Annatto Seed Tocotrienols Extract [NEW] (USP40-NF35 1S) ...................................... 171

Bifidobacterium Animalis Ssp. Lactis [NEW] (USP40-NF35 1S) ..................................... 172

Cobamamide [NEW] (USP40-NF35 1S) ...................................................... 175

Echinacea Species Dry Extract Capsules [NEW] (USP40-NF35 1S) ................................... 176

Echinacea Species Dry Extract Tablets [NEW] (USP40-NF35 1S) .................................... 179

NF Monographs

Neotame (USP40-NF35 1S) ............................................................... 182

Palmitic Acid (USP40-NF35 1S) ............................................................ 183

Stage 4 Harmonization

Stage 4 Harmonization Introduction ........................................................ 187

NF Monographs

Microcrystalline Cellulose ................................................................ 189

Copovidone .......................................................................... 191

Stimuli to the Revision Process

Stimuli to the Revision Process Introduction .................................................. 195

Factors to Consider in Setting Adequate Overages of Vitamins and Minerals in Dietary Supplements ....... 197

Pharmacopeial Forum Vol. 42(4) [Jul.–Aug. 2016] i

Table of Contents

Journal of Standards Development ........................................................... 1

Pharmacopeial Forum’s Public Review and Comment Process ....................................... 3

How to Use PF .......................................................................... 5

Proposed IRA

Proposed Interim Revision Announcements Introduction .......................................... 7

USP Monographs

Acitretin Capsules (1-Jan-2017) ............................................................. 9

Aspirin Boluses (1-Jan-2017) ............................................................... 11

Aspirin Delayed-Release Capsules (1-Jan-2017) .................................................. 13

Aspirin Tablets (1-Jan-2017) ................................................................ 14

Buffered Aspirin Tablets (1-Jan-2017) ......................................................... 15

Aspirin Delayed-Release Tablets (1-Jan-2017) ................................................... 17

Aspirin Effervescent Tablets for Oral Solution (1-Jan-2017) ......................................... 18

Aspirin Extended-Release Tablets (1-Jan-2017) .................................................. 19

Aspirin, Alumina, and Magnesia Tablets (1-Jan-2017) ............................................. 21

Doxorubicin Hydrochloride Injection (1-Jan-2017) ............................................... 23

Eprinomectin (1-Jan-2017) ................................................................. 25

Naproxen Sodium Tablets (1-Jan-2017) ....................................................... 27

NF Monographs

Octyldodecanol (USP40-NF35 2S) ........................................................... 30

In-Process Revision

In-Process Revision Introduction ............................................................. 35

General Chapters

〈91〉 Calcium Pantothenate Assay (USP40-NF35 2S) .............................................. 37

〈115〉 Dexpanthenol Assay (USP40-NF35 2S) ................................................... 42

〈661.1〉 Plastic Materials of Construction (USP40-NF35 2S) ........................................ 44

〈661.2〉 Plastic Packaging Systems for Pharmaceutical Use (USP40-NF35 2S) ........................... 62

〈771〉 Opthalmic Products—Quality Tests (USP40-NF35 2S) ........................................ 66

〈781〉 Optical Rotation (USP40-NF35 2S) ...................................................... 71

〈785〉 Osmolality and Osmolarity (USP40-NF35 2S) .............................................. 73

〈857〉 Ultraviolet-Visible Spectroscopy (USP40-NF35 2S) ........................................... 77

〈1079.1〉 Storage and Transportation of Investigational Drug Products [NEW](USP40-NF35 2S) ............. 85

〈1090〉 Assessment of Drug Product Performance—Bioavailability, Bioequivalence, and Dissolution (USP40-NF35

2S) ................................................................................. 90

〈1857〉 Ultraviolet-Visible Spectroscopy—Theory and Practice (USP40-NF35 2S) ......................... 100

Reagents, Indicators, and Solutions

Reagent Specifications ................................................................... 112

Benzil [NEW] (USP40-NF35 2S) ............................................................. 112

Butylparaben [NEW] (USP40-NF35 2S) ....................................................... 112

Desoxycorticosterone Acetate [NEW] (USP40-NF35 2S) ........................................... 112

Linolenic Acid [NEW] (USP40-NF35 2S) ....................................................... 112

(R)-(–)-Littorine Hydrochloride [NEW] (USP40-NF35 2S) ........................................... 112

ii Pharmacopeial Forum Vol. 42(4) [Jul.–Aug. 2016]

p-Methoxyacetophenone [NEW] (USP40-NF35 2S) .............................................. 112

Polyvinyl Alcohol (USP40-NF35 2S) .......................................................... 113

Undecanoic Acid [NEW] (USP40-NF35 2S) ..................................................... 113

Test Solutions .......................................................................... 113

0.125 N Hydrochloric Acid TS [NEW] (USP40-NF35 2S) ........................................... 113

1.5 M Phosphoric Acid TS [NEW] (USP40-NF35 2S) .............................................. 113

0.1% Trifluoroacetic Acid TS [NEW] (USP40-NF35 2S) ............................................ 113

Volumetric Solutions .................................................................... 113

0.05 M Barium Perchlorate VS [NEW] (USP40-NF35 2S) .......................................... 113

Chromatographic Columns ............................................................... 114

L102 [NEW] (USP40-NF35 2S) .............................................................. 114

Reference Tables

Container Specifications [NEW] (USP40-NF35 2S) ............................................... 115

Description and Solubility (USP40-NF35 2S) ................................................... 116

USP Monographs

Acetaminophen, Guaifenesin, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride Tablets

[NEW] (USP40-NF35 2S) ................................................................ 117

Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride Tablets [NEW] (USP40-NF35 2S) ........... 121

Acetaminophen, Phenylephrine Hydrochloride, Chlorpheniramine Maleate, and Dextromethorphan

Hydrobromide Oral Suspension [NEW] (USP40-NF35 2S) ........................................ 125

Atropine Sulfate Injection (USP40-NF35 2S) .................................................... 128

Atropine Sulfate Ophthalmic Ointment (USP40-NF35 2S) ......................................... 129

Atropine Sulfate Ophthalmic Solution (USP40-NF35 2S) .......................................... 132

Bimatoprost [NEW] (USP40-NF35 2S) ........................................................ 134

Bimatoprost Ophthalmic Solution [NEW] (USP40-NF35 2S) ........................................ 135

Brimonidine Tartrate [NEW] (USP40-NF35 2S) .................................................. 136

Cinacalcet Hydrochloride [NEW] (USP40-NF35 2S) .............................................. 138

Cinacalcet Tablets [NEW] (USP40-NF35 2S) .................................................... 140

Cinoxacin (USP40-NF35 2S) ............................................................... 142

Cinoxacin Capsules (USP40-NF35 2S) ........................................................ 143

Cyclophosphamide Tablets (USP40-NF35 2S) ................................................... 144

Desoxycorticosterone Acetate (USP40-NF35 2S) ................................................. 146

Desoxycorticosterone Acetate Injection (USP40-NF35 2S) ......................................... 146

Desoxycorticosterone Acetate Pellets (USP40-NF35 2S) ........................................... 147

Dexamethasone (USP40-NF35 2S) ........................................................... 147

Dexmedetomidine Injection [NEW] (USP40-NF35 2S) ............................................ 150

Diclofenac Potassium (USP40-NF35 2S) ....................................................... 151

Diclofenac Sodium (USP40-NF35 2S) ......................................................... 153

Dienestrol (USP40-NF35 2S) ............................................................... 156

Dienestrol Cream (USP40-NF35 2S) .......................................................... 156

Doxycycline Calcium Oral Suspension (USP40-NF35 2S) .......................................... 157

Doxycycline Hyclate Delayed-Release Tablets (USP40-NF35 2S) ..................................... 160

Eptifibatide [NEW] (USP40-NF35 2S) ......................................................... 164

Famciclovir Tablets [NEW] (USP40-NF35 2S) ................................................... 166

Fingolimod Hydrochloride [NEW] (USP40-NF35 2S) .............................................. 168

Fluvastatin Sodium Extended-Release Tablets [NEW] (USP40-NF35 2S) ................................ 170

Guanidine Hydrochloride [NEW] (USP40-NF35 2S) .............................................. 171

Hypromellose Capsule Shell [NEW] (USP40-NF35 2S) ............................................ 173

Linezolid [NEW] (USP40-NF35 2S) ........................................................... 173

Lorazepam (USP40-NF35 2S) ............................................................... 175

Metoprolol Tartrate and Hydrochlorothiazide Tablets (USP40-NF35 2S) ............................... 177

Pharmacopeial Forum Vol. 42(4) [Jul.–Aug. 2016] iii

Nandrolone Phenpropionate (USP40-NF35 2S) ................................................. 181

Nandrolone Phenpropionate Injection (USP40-NF35 2S) .......................................... 182

Naproxen (USP40-NF35 2S) ............................................................... 183

Naproxen Oral Suspension (USP40-NF35 2S) ................................................... 185

Naproxen Delayed-Release Tablets (USP40-NF35 2S) ............................................. 187

Naproxen Sodium (USP40-NF35 2S) ......................................................... 190

Oxaprozin (USP40-NF35 2S) ............................................................... 192

Paraldehyde (USP40-NF35 2S) .............................................................. 194

Pioglitazone and Metformin Hydrochloride Tablets (USP40-NF35 2S) ................................. 196

Pramipexole Dihydrochloride (USP40-NF35 2S) ................................................. 200

Reserpine Injection (USP40-NF35 2S) ......................................................... 202

Reserpine Oral Solution (USP40-NF35 2S) ..................................................... 203

Reserpine and Hydrochlorothiazide Tablets (USP40-NF35 2S) ....................................... 204

Riluzole Tablets (USP40-NF35 2S) ........................................................... 206

Sodium Acetate (USP40-NF35 2S) ........................................................... 207

Sulfamethoxazole (USP40-NF35 2S) .......................................................... 208

Telmisartan and Amlodipine Tablets [NEW] (USP40-NF35 2S) ...................................... 211

Terbinafine Tablets (USP40-NF35 2S) ......................................................... 213

Trandolapril and Verapamil Hydrochloride Extended-Release Tablets (USP40-NF35 2S) .................... 215

Tranylcypromine Tablets (USP40-NF35 2S) ..................................................... 221

Triacetin (USP40-NF35 2S) ................................................................. 223

Zolpidem Tartrate Tablets (USP40-NF35 2S) .................................................... 225

Zonisamide Capsules (USP40-NF35 2S) ....................................................... 227

DS Monographs

Conjugated Linoleic Acids–Free Fatty Acids [NEW] (USP40-NF35 2S) ................................. 230

Conjugated Linoleic Acids–Triglycerides [NEW] (USP40-NF35 2S) .................................... 231

Rhodiola crenulata Root and Rhizome [NEW] (USP40-NF35 2S) ..................................... 233

Rhodiola crenulata Root and Rhizome Dry Extract [NEW] (USP40-NF35 2S) ............................ 235

Rhodiola crenulata Root and Rhizome Powder [NEW] (USP40-NF35 2S) .............................. 236

NF Monographs

Octyldodecanol (USP40-NF35 2S) ........................................................... 239

Excipients

USP and NF Excipients, Listed by Category .................................................... 243

Stage 4 Harmonization

Stage 4 Harmonization ................................................................... 245

Stimuli to the Revision Process

Stimuli to the Revision Process .............................................................. 247

The Effect of Primary Packaging on the Physical Degradation of Metformin, Lisinopril, and Simvastatin Solid

Doses During Patient Use When Stored at Different Temperature and Humidity Conditions .............. 249

Future of Element-Specific Chapters in the USP–NF .............................................. 261

Rationale for the Omission of the Packaging and Storage Statement from USP–NF Monographs and the Omis-

sion of the “Well-Closed” Specification from Containers—Performance Testing 〈671〉 .................... 262

Table of Contents

PROPOSED IRA

Proposed Interim Revision Announcements

USP MONOGRAPHS

Anastrozole Tablets (1-Mar-2017)

IN-PROCESS REVISION

In-Process Revision

GENERAL CHAPTERS

<161> Medical Devices - Bacterial Endotoxin and Pyrogen Tests (USP40-NF35 2S)

<197> Spectrophotometric Identification Tests (USP40-NF35 2S)

<503> Acetic Acid In Peptides (USP40-NF35 2S)

<503.1> Trifluoroacetic Acid (TFA) in Peptides (USP40-NF35 2S)

<509> Residual DNA Testing [NEW] (USP40-NF35 2S)

<1062> Tablet Compression Characterization [NEW] (USP40-NF35 2S)

<1080> Bulk Pharmaceutical Excipients - Certificate of Analysis (USP40-NF35 2S)

<1210> Statistical Tools for Procedure Validation [NEW] (USP40-NF35 2S)

<1211> Sterilization and Sterility Assurance of Compendial Articles (USP40-NF35 2S)

<1229.14> Sterilization Cycle Development [NEW] (USP40-NF35 2S)

<1229.15> Sterilizing Filtration of Gases [NEW] (USP40-NF35 2S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Dihydroxybenzaldehyde [NEW] (USP40-NF35 2S)

Dihydroxyphenylacetone [NEW] (USP40-NF35 2S)

7,8-Dihydrofolic Acid [NEW] (USP40-NF35 2S)

Hydroxypropyl-[BETA]-cyclodextrin (USP40-NF35 2S)

Mercurous Nitrate Dihydrate (USP40-NF35 2S)

Methyl Isobutyrate [NEW] (USP40-NF35 2S)

Nickel Sulfate (USP40-NF35 2S)

n-Octane [NEW] (USP40-NF35 2S)

Tetraethylammonium Chloride [NEW] (USP40-NF35 2S)

Triazolam [NEW] (USP40-NF35 2S)

Indicators

Phenolphthalein (USP40-NF35 2S)

Test Solutions

0.008 M Acetic Acid TS [NEW] (USP40-NF35 2S)

0.3 N Acetic Acid TS [NEW] (USP40-NF35 2S)

0.08 N Hydrochloric Acid TS [NEW] (USP40-NF35 2S)

0.75 M Phosphoric Acid TS [NEW] (USP40-NF35 2S)

REFERENCE TABLES

Containers for Dispensing Capsules and Tablets

PF 42(5): Sep.-Oct. 2016

Containers for Dispensing Capsules and Tablets [NEW] (USP40-NF35 2S)

Description and Relative Solubility of USP and NF Articles

Description and Relative Solubility of USP and NF Articles (USP40-NF35 2S)

Description and Solubility - G

Description and Solubility - M

Description and Solubility - O

Description and Solubility - R

USP MONOGRAPHS

Acetaminophen and Aspirin Tablets (USP40-NF35 2S)

Acetaminophen, Aspirin, and Caffeine Tablets (USP40-NF35 2S)

Anagrelide Capsules (USP40-NF35 2S)

Antipyrine and Benzocaine Otic Solution (USP40-NF35 2S)

Ascorbic Acid Compounded Oral Solution [NEW] (USP40-NF35 2S)

Baclofen Tablets (USP40-NF35 2S)

Betamethasone Acetate (USP40-NF35 2S)

Betamethasone Dipropionate Topical Aerosol (USP40-NF35 2S)

Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension (USP40-NF35 2S)

Budesonide Delayed-Release Capsules [NEW] (USP40-NF35 2S)

Carbidopa and Levodopa Tablets (USP40-NF35 2S)

Cytarabine (USP40-NF35 2S)

Decoquinate Premix (USP40-NF35 2S)

Dexamethasone Sodium Phosphate Compounded Injection [NEW] (USP40-NF35 2S)

Divalproex Sodium (USP40-NF35 2S)

Divalproex Sodium Delayed-Release Tablets (USP40-NF35 2S)

Divalproex Sodium Extended-Release Tablets (USP40-NF35 2S)

Docetaxel Injection (USP40-NF35 2S)

Doxycycline for Oral Suspension (USP40-NF35 2S)

Estriol Compounded Vaginal Cream [NEW] (USP40-NF35 2S)

Fentanyl Citrate Compounded Injection [NEW] (USP40-NF35 2S)

Fentanyl Citrate and Bupivacaine Hydrochloride Compounded Injection [NEW] (USP40-NF35 2S)

Fentanyl Citrate and Ropivacaine Hydrochloride Compounded Injection [NEW] (USP40-NF35 2S)

Flutamide Capsules (USP40-NF35 2S)

Fluvoxamine Maleate (USP40-NF35 2S)

Fluvoxamine Maleate Tablets (USP40-NF35 2S)

Folic Acid Compounded Oral Solution [NEW] (USP40-NF35 2S)

Fondaparinux Sodium (USP40-NF35 2S)

Fondaparinux Sodium Injection (USP40-NF35 2S)

Hydralazine Hydrochloride (USP40-NF35 2S)

Hydralazine Hydrochloride Tablets (USP40-NF35 2S)

Hydrocortisone Injectable Suspension (USP40-NF35 2S)

Hydrocortisone Acetate Injectable Suspension (USP40-NF35 2S)

Hydrocortisone Acetate Ophthalmic Suspension (USP40-NF35 2S)

Indomethacin Capsules (USP40-NF35 2S)

Insulin Aspart (USP40-NF35 2S)

Diluted Isosorbide Dinitrate (USP40-NF35 2S)

Isosorbide Dinitrate Tablets (USP40-NF35 2S)

Leucovorin Calcium (USP40-NF35 2S)

Leucovorin Calcium for Injection [NEW] (USP40-NF35 2S)

Lithium Hydroxide (USP40-NF35 2S)

Mefenamic Acid (USP40-NF35 2S)

Mefenamic Acid Capsules (USP40-NF35 2S)

Meropenem (USP40-NF35 2S)

PF 42(5): Sep.-Oct. 2016

Meropenem for Injection (USP40-NF35 2S)

Methohexital (USP40-NF35 2S)

Methohexital Sodium for Injection (USP40-NF35 2S)

Methylnaltrexone Bromide [NEW] (USP40-NF35 2S)

Metoprolol Succinate Extended-Release Tablets (USP40-NF35 2S)

Monensin Premix (USP40-NF35 2S)

Morphine Sulfate Compounded Injection [NEW] (USP40-NF35 2S)

Narasin Premix (USP40-NF35 2S)

Nimodipine (USP40-NF35 2S)

Olanzapine and Fluoxetine Capsules (USP40-NF35 2S)

Ondansetron Compounded Topical Gel [NEW] (USP40-NF35 2S)

Oxiconazole Nitrate [NEW] (USP40-NF35 2S)

Pentazocine (USP40-NF35 2S)

Pentazocine Injection (USP40-NF35 2S)

Phenytoin Chewable Tablets (USP40-NF35 2S)

Potassium Phosphates Compounded Injection [NEW] (USP40-NF35 2S)

Protriptyline Hydrochloride Tablets (USP40-NF35 2S)

Raltegravir Tablets [NEW] (USP40-NF35 2S)

Raltegravir Chewable Tablets [NEW] (USP40-NF35 2S)

Raltegravir Potassium [NEW] (USP40-NF35 2S)

Sodium Bicarbonate Compounded Injection [NEW] (USP40-NF35 2S)

Sodium Phosphates Compounded Injection [NEW] (USP40-NF35 2S)

Silver Sulfadiazine (USP40-NF35 2S)

Teriparatide (USP40-NF35 2S)

Teriparatide Injection (USP40-NF35 2S)

Trandolapril Tablets (USP40-NF35 2S)

Trihexyphenidyl Hydrochloride Oral Solution (USP40-NF35 2S)

DIETARY SUPPLEMENT MONOGRAPHS

Tangerine Peel [NEW] (USP40-NF35 2S)

Tangerine Peel Powder [NEW] (USP40-NF35 2S)

Tangerine Peel Dry Extract [NEW] (USP40-NF35 2S)

EXCIPIENTS

USP and NF Excipients, Listed By Category (USP40-NF35 2S)

Briefing

Introduction

Coating Agent

Diluent

Emulsifying Agent

Film-Forming Agent

Lubricant

Vehicle (solid carrier)

Wet Binder

NF MONOGRAPHS

Almond Oil (USP40-NF35 2S)

Aluminum Monostearate (USP40-NF35 2S)

Canola Oil (USP40-NF35 2S)

Cetyl Esters Wax (USP40-NF35 2S)

Corn Oil (USP40-NF35 2S)

Cottonseed Oil (USP40-NF35 2S)

PF 42(5): Sep.-Oct. 2016

Dichlorodifluoromethane (USP40-NF35 2S)

Dichlorotetrafluoroethane (USP40-NF35 2S)

Ethyl Acetate (USP40-NF35 2S)

Glyceryl Tricaprylate [NEW] (USP40-NF35 2S)

Myristic Acid (USP40-NF35 2S)

Peanut Oil (USP40-NF35 2S)

Polyoxyl 40 Hydrogenated Castor Oil (USP40-NF35 2S)

Sodium Hydroxide (USP40-NF35 2S)

Sodium Lauryl Sulfate (USP40-NF35 2S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

USP MONOGRAPHS

Hypromellose

Methylcellulose

STIMULI TO THE REVISION PROCESS

Stimuli to The Revision Process

Analytical Control Strategy

Analytical Target Profile: Structure and Application Throughout The Analytical Lifecycle

Applying The USP <905> Content Uniformity Zero Tolerance Criterion to Large Sample Sizes

Responses to Stimuli Article, "Medicines Marketed Under the Food and Drug Administration Over-The-Counter Drug

Monograph System Regulations: Strategy for Developing Compendial Quality Standards"

USP Responses to Comments On Stimuli Article Proposed New USP General Information Chapter. "Tablet

Compression Characterization <1062>"

PF 42(5): Sep.-Oct. 2016

Table of Contents

PROPOSED IRA

Proposed Interim Revision Announcements

USP MONOGRAPHS

Almotriptan Malate (1-May-2017)

Topiramate (1-May-2017)

IN-PROCESS REVISION

In-Process Revision

GENERAL CHAPTERS

<227> 4-AMINOPHENOL IN ACETAMINOPHEN-CONTAINING DRUG PRODUCTS (USP41-NF36)

<591> ZINC DETERMINATION (USP41-NF36)

<601> INHALATION AND NASAL DRUG PRODUCTS: AEROSOLS, SPRAYS, AND POWDERS—

PERFORMANCE QUALITY TESTS (USP41-NF36)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Octanesulfonic Acid Sodium Salt, Monohydrate [NEW] (USP41-NF36)

Chromatographic Columns

L52 (USP41-NF36)

L100 [NEW] (USP41-NF36)

L103 [NEW] (USP41-NF36)

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets [NEW] (USP41-NF36)

Description and Relative Solubility of USP and NF Articles

Description and Relative Solubility of USP and NF Articles (USP41-NF36)

Description and Solubility - B

Description and Solubility - D

Description and Solubility - G

USP MONOGRAPHS

Acetaminophen Oral Suspension (USP41-NF36)

PF 42(6): Nov.-Dec. 2016 1

Acetazolamide for Injection (USP41-NF36)

Acetazolamide Tablets (USP41-NF36)

Amikacin (USP41-NF36)

Amikacin Sulfate (USP41-NF36)

Amikacin Sulfate Injection (USP41-NF36)

Amoxicillin Capsules (USP41-NF36)

Amoxicillin for Oral Suspension (USP41-NF36)

Amoxicillin Tablets (USP41-NF36)

Benzethonium Chloride (USP41-NF36)

Betamethasone Dipropionate Cream (USP41-NF36)

Betamethasone Dipropionate Lotion (USP41-NF36)

Bortezomib [NEW] (USP41-NF36)

Bortezomib for Injection [NEW] (USP41-NF36)

Cefaclor (USP41-NF36)

Cefaclor Capsules (USP41-NF36)

Cefaclor for Oral Suspension (USP41-NF36)

Cefaclor Chewable Tablets (USP41-NF36)

Cefaclor Extended-Release Tablets (USP41-NF36)

Choline Fenofibrate [NEW] (USP41-NF36)

Cyanocobalamin Co 57 Capsules (USP41-NF36)

Cyanocobalamin Co 57 Oral Solution (USP41-NF36)

Cyanocobalamin Co 58 Capsules (USP41-NF36)

Epinephrine (USP41-NF36)

Everolimus [NEW] (USP41-NF36)

Fenofibric Acid Delayed-Release Capsules [NEW] (USP41-NF36)

Fluticasone Propionate Nasal Spray (USP41-NF36)

Gatifloxacin [NEW] (USP41-NF36)

Gatifloxacin Ophthalmic Solution [NEW] (USP41-NF36)

Glimepiride (USP41-NF36)

Glimepiride Tablets (USP41-NF36)

Granisetron [NEW] (USP41-NF36)

Itraconazole (USP41-NF36)

Lorazepam Injection (USP41-NF36)

Megestrol Acetate (USP41-NF36)

Megestrol Acetate Tablets (USP41-NF36)

Menthol (USP41-NF36)

Milrinone Lactate Injection [NEW] (USP41-NF36)

Moxifloxacin Ophthalmic Solution (USP41-NF36)

Pralidoxime Chloride (USP41-NF36)

Pralidoxime Chloride for Injection (USP41-NF36)

Reserpine (USP41-NF36)

Reserpine Tablets (USP41-NF36)

Tacrine Hydrochloride (USP41-NF36)

Tacrine Capsules (USP41-NF36)

Temozolomide Capsules [NEW] (USP41-NF36)

Temozolomide for Injection [NEW] (USP41-NF36)

Triamterene (USP41-NF36)

Tropicamide Ophthalmic Solution (USP41-NF36)

PF 42(6): Nov.-Dec. 2016 2

Warfarin Sodium (USP41-NF36)

Zinc Oxide (USP41-NF36)

Zinc Oxide Neutral (USP41-NF36)

Zinc Sulfate Ophthalmic Solution (USP41-NF36)

DIETARY SUPPLEMENT MONOGRAPHS

Citicoline Sodium [NEW] (USP41-NF36)

Coix Seed [NEW] (USP41-NF36)

Coix Seed Powder [NEW] (USP41-NF36)

Echinacea Species Powder Capsules [NEW] (USP41-NF36)

NF MONOGRAPHS

Dextrose Excipient (USP41-NF36)

Gelatin (USP41-NF36)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

USP MONOGRAPHS

Anhydrous Dibasic Calcium Phosphate

STIMULI TO THE REVISION PROCESS

Analytical Gaps and Challenges for Particles in the Submicrometer Size Domain

The Application of Abbreviated Impactor Measurement and Efficient Data Analysis in the

Lifecycle of an Orally-Inhaled Product: A Roadmap

The Journal of Standards Development and Official Compendia Revision

Executive Vice President and Chief Science Officer; Chair, USP Council of Experts

Jaap Venema, Ph.D.

Chief Executive Officer

Ronald T. Piervincenzi, Ph.D.

Executive Vice President and Chief Legal Officer

Susan S. de Mars, J.D.

Senior Vice President, Global Biologics

Tina S. Morris, Ph.D.

Senior Vice President, Chemical Medicines and General Chapters

Robert A. Femia, Ph.D.

Vice President, Science—Dietary Supplements and Herbal Medicines

Gabriel Giancaspro, Ph.D.

Senior Director, Science and Standards, Biologics

PF 42(6): Nov.-Dec. 2016 3

Table of Contents

PROPOSED IRA

Proposed Interim Revision Announcements

USP MONOGRAPHS

Sulindac Tablets (1-Jul-2017)

IN-PROCESS REVISION

In-Process Revision

GENERAL NOTICES FOR USP-NF

General Notices to USP-NF (USP41-NF36)

1. TITLE AND REVISION

2. OFFICIAL STATUS AND LEGAL RECOGNITION

3. CONFORMANCE TO STANDARDS

4. MONOGRAPHS AND GENERAL CHAPTERS

5. MONOGRAPH COMPONENTS

6. TESTING PRACTICES AND PROCEDURES

7. TEST RESULTS

8. TERMS AND DEFINITIONS

9. PRESCRIBING AND DISPENSING

10. PRESERVATION, PACKAGING, STORAGE, AND LABELING

GENERAL CHAPTERS

<5> INHALATION AND NASAL DRUG PRODUCTS-GENERAL INFORMATION AND PRODUCT QUALITY

TESTS (USP41-NF36)

<671> CONTAINERS-PERFORMANCE TESTING (USP41-NF36)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Aluminum Chloride [NEW] (USP41-NF36)

Bromelain (USP41-NF36)

Dipicolinic Acid [NEW] (USP41-NF36)

Gelatin [NEW] (USP41-NF36)

Pancreatic Digest of Casein (USP41-NF36)

6Z-Retinoic Acid (USP41-NF36)

PF 43(1) Jan.–Feb. 2017 1

Indicators

Indicators Introduction (USP41-NF36)

Indicator and Test Papers Introduction (USP41-NF36)

Buffer Solutions

Buffer Solutions (USP41-NF36)

Colorimetric Solutions

Colorimetric Solutions Introduction (USP41-NF36)

Test Solutions

Test Solutions Introduction (USP41-NF36)

5 N Hydrochloric Acid TS [NEW] (USP41-NF36)

0.01 M Phosphoric Acid TS [NEW] (USP41-NF36)

0.01% Phosphoric Acid TS (USP41-NF36)

10 M Potassium Hydroxide TS [NEW] (USP41-NF36)

0.5 M Sodium Chloride TS [NEW] (USP41-NF36)

Volumetric Solutions

Volumetric Solutions Introduction (USP41-NF36)

0.1 N Potassium Hydroxide VS [NEW] (USP41-NF36)

0.01 N Sodium Hydroxide VS [NEW] (USP41-NF36)

0.5 N Sodium Hydroxide VS [NEW] (USP41-NF36)

0.01 M Sodium Thiosulfate VS [NEW] (USP41-NF36)

Chromatographic Columns

L108 [NEW] (USP41-NF36)

L109 [NEW] (USP41-NF36)

REFERENCE TABLES

Container Specifications

Containers for Dispensing Capsules and Tablets [NEW] (USP41-NF36)

Description and Relative Solubility of USP and NF Articles

Description and Relative Solubility of USP and NF Articles (USP41-NF36)

Description and Solubility - B

Description and Solubility - I

Description and Solubility - P

Description and Solubility - R

USP MONOGRAPHS

Alclometasone Dipropionate Cream (USP41-NF36)

Alclometasone Dipropionate Ointment (USP41-NF36)

Aminobenzoic Acid Topical Solution (USP41-NF36)

Atropine (USP41-NF36)

BCG Live (USP41-NF36)

PF 43(1) Jan.–Feb. 2017 2

BCG Vaccine (USP41-NF36)

Bendamustine Hydrochloride [NEW] (USP41-NF36)

Bendamustine Hydrochloride for Injection [NEW] (USP41-NF36)

Betamethasone Tablets (USP41-NF36)

Cyclophosphamide for Injection (USP41-NF36)

Cyclosporine (USP41-NF36)

Cyclosporine Capsules (USP41-NF36)

Cyclosporine Injection (USP41-NF36)

Cyclosporine Oral Solution (USP41-NF36)

Cyproheptadine Hydrochloride Tablets (USP41-NF36)

Fludrocortisone Acetate Tablets (USP41-NF36)

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution [NEW] (USP41-NF36)

Mesna (USP41-NF36)

Mesna Injection [NEW] (USP41-NF36)

Mesna Tablets [NEW] (USP41-NF36)

Mycophenolic Acid Delayed-Release Tablets (USP41-NF36)

Prasugrel Hydrochloride [NEW] (USP41-NF36)

Ropivacaine [NEW] (USP41-NF36)

Sibutramine Hydrochloride (USP41-NF36)

Simvastatin Tablets (USP41-NF36)

Sodium Fluoride Oral Solution (USP41-NF36)

Sodium Fluoride and Acidulated Phosphate Topical Solution (USP41-NF36)

Telmisartan (USP41-NF36)

Verapamil Hydrochloride Extended-Release Capsules (USP41-NF36)

Zidovudine (USP41-NF36)

Zidovudine Oral Solution (USP41-NF36)

Zinc Oxide Powder [NEW] (USP41-NF36)

Zolmitriptan Nasal Spray [NEW] (USP41-NF36)

DIETARY SUPPLEMENT MONOGRAPHS

Bacillus coagulans GBI-30, 6086 [NEW] (USP41-NF36)

Bacillus coagulans GBI-30, 6086 Capsules [NEW] (USP41-NF36)

EXCIPIENTS

USP and NF Excipients, Listed by Category (USP41-NF36)

Briefing

Introduction

Emollient

Emulsifying Agent

NF MONOGRAPHS

Isopropyl Isostearate [NEW] (USP41-NF36)

Isostearyl Isostearate [NEW] (USP41-NF36)

PF 43(1) Jan.–Feb. 2017 3

STAGE 4 HARMONIZATION

Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS

Pharmaceutical Foams

Proposed New USP General Chapter: The Analytical Procedure Lifecycle <1220>

PF 43(1) Jan.–Feb. 2017 4

Table of Contents

PROPOSED IRA

Proposed Interim Revision Announcements

USP MONOGRAPHS

Amlodipine and Valsartan Tablets (1-Sep-2017)

Amlodipine, Valsartan and Hydrochlorothiazide Tablets (1-Sep-2017)

Levocetirizine Dihydrochloride (1-Sep-2017)

Pyridostigmine Bromide Tablets (1-Sep-2017)

Valine (1-Sep-2017)

IN-PROCESS REVISION

In-Process Revision

GENERAL CHAPTERS

<64> Probiotic Tests [NEW] (USP41-NF36 1S)

<198> Nuclear Magnetic Resonance Spectroscopy Identity Testing of Bacterial Polysaccharides

Used In Vaccine Manufacture [NEW] (USP41-NF36 1S)

<467> Residual Solvents (USP41-NF36 1S)

<724> Drug Release (USP41-NF36 1S)

<741> Melting Range or Temperature (USP41-NF36 1S)

<915> Measurement of Structural Strength of Semisolids By Penetrometry [NEW] (USP41-NF36

1S)

<1151> Pharmaceutical Dosage Forms (USP41-NF36 1S)

<1231> Water for Pharmaceutical Purposes (USP41-NF36 1S)

<1236> Solubility Measurements [NEW] (USP41-NF36 1S)

<1467> Residual Solvents- Verification of Compendial Procedures and Validation of Alternative

Procedures [NEW] (USP41-NF36 1S)

<1912> Measurement of Hardness of Semisolids [NEW] (USP41-NF36 1S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Cadmium Nitrate (USP41-NF36 1S)

2-Chloroethylamine Monohydrochloride (USP41-NF36 1S)

Cupric Nitrate Hydrate (USP41-NF36 1S)

3-Cyclohexylpropionic Acid [NEW] (USP41-NF36 1S)

N,N'-Diisopropylethylenediamine [NEW] (USP41-NF36 1S)

2-Ethylhexanoic Acid [NEW] (USP41-NF36 1S)

(plusminus)-1-(9-Fluorenyl)ethanol [NEW] (USP41-NF36 1S)

(+)-1-(9-Fluorenyl)ethyl Chloroformate Solution [NEW] (USP41-NF36 1S)

PF 43(2): Mar.-Apr. 2017 1

25% Hydrochloric Acid [NEW] (USP41-NF36 1S)

Isopropyl Stearate [NEW] (USP41-NF36 1S)

Isostearic Acid [NEW] (USP41-NF36 1S)

L-Cystine (USP41-NF36 1S)

3-Mercaptopropionic Acid [NEW] (USP41-NF36 1S)

3-Methyl-2-Pentanone [NEW] (USP41-NF36 1S)

4-Morpholine Propane Sulfonic Acid [NEW] (USP41-NF36 1S)

Nitric Acid, Ultratrace [NEW] (USP41-NF36 1S)

Phenylacetic Acid [NEW] (USP41-NF36 1S)

Sodium Phosphate [NEW] (USP41-NF36 1S)

Sulfuric Acid, Diluted (USP41-NF36 1S)

1,1,3,3-Tetramethylbutylamine [NEW] (USP41-NF36 1S)

Tetramethylethylenediamine [NEW] (USP41-NF36 1S)

Test Solutions

4 N Hydrochloric Acid TS [NEW] (USP41-NF36 1S)

0.05 M Monobasic Sodium Phosphate TS [NEW] (USP41-NF36 1S)

0.1 M Monobasic Sodium Phosphate TS [NEW] (USP41-NF36 1S)

Volumetric Solutions

0.1 N Ceric Sulfate VS (USP41-NF36 1S)

0.02 N Sulfuric Acid VS [NEW] (USP41-NF36 1S)

Chromatographic Columns

L52 (USP41-NF36 1S)

L110 [NEW] (USP41-NF36 1S)

REFERENCE TABLES

Container Specifications

Container Specifications [NEW] (USP41-NF36 1S)

Description and Solubility

Description and Relative Solubility of USP and NF Articles (USP41-NF36 1S)

Description and Solubility - C

Description and Solubility - D

Description and Solubility - E

Description and Solubility - F

Description and Solubility - I

USP MONOGRAPHS

Acamprosate Calcium [NEW] (USP41-NF36 1S)

Alosetron Hydrochloride [NEW] (USP41-NF36 1S)

Alosetron Tablets [NEW] (USP41-NF36 1S)

Aminobenzoic Acid Gel (USP41-NF36 1S)

Amlodipine and Atorvastatin Tablets (USP41-NF36 1S)

Ampicillin (USP41-NF36 1S)

PF 43(2): Mar.-Apr. 2017 2

Aztreonam (USP41-NF36 1S)

Betamethasone (USP41-NF36 1S)

Calcium Acetate Capsules [NEW] (USP41-NF36 1S)

Calcium Citrate Malate [NEW] (USP41-NF36 1S)

Candesartan Cilexetil and Hydrochlorothiazide Tablets (USP41-NF36 1S)

Cholecalciferol Tablets [NEW] (USP41-NF36 1S)

Chymotrypsin (USP41-NF36 1S)

Chymotrypsin for Ophthalmic Solution (USP41-NF36 1S)

Clarithromycin (USP41-NF36 1S)

Colchicine (USP41-NF36 1S)

Cortisone Acetate (USP41-NF36 1S)

Cortisone Acetate Injectable Suspension (USP41-NF36 1S)

Cortisone Acetate Tablets (USP41-NF36 1S)

Cyclopentolate Hydrochloride (USP41-NF36 1S)

Dexamethasone Sodium Phosphate Inhalation Aerosol (USP41-NF36 1S)

Doxycycline Hyclate Capsules (USP41-NF36 1S)

Doxycycline Hyclate Tablets (USP41-NF36 1S)

Epinastine Hydrochloride [NEW] (USP41-NF36 1S)

Ergotamine Tartrate Inhalation Aerosol (USP41-NF36 1S)

Glycine (USP41-NF36 1S)

Hydrocortisone Acetate Ophthalmic Ointment (USP41-NF36 1S)

Levocarnitine (USP41-NF36 1S)

Meloxicam Oral Suspension (USP41-NF36 1S)

Methylphenidate Hydrochloride (USP41-NF36 1S)

Miconazole Nitrate (USP41-NF36 1S)

Miconazole Nitrate Topical Powder (USP41-NF36 1S)

Minocycline Hydrochloride (USP41-NF36 1S)

Naratriptan Tablets (USP41-NF36 1S)

Nifedipine Capsules (USP41-NF36 1S)

Norelgestromin (USP41-NF36 1S)

Omega-3-Acids Ethyl Esters (USP41-NF36 1S)

Oxiconazole Nitrate Cream [NEW] (USP41-NF36 1S)

Oxiconazole Nitrate Lotion [NEW] (USP41-NF36 1S)

Pamabrom (USP41-NF36 1S)

Pantoprazole Sodium (USP41-NF36 1S)

Perphenazine Injection (USP41-NF36 1S)

Perphenazine Oral Solution (USP41-NF36 1S)

Perphenazine Syrup (USP41-NF36 1S)

Prilocaine Hydrochloride Injection (USP41-NF36 1S)

Rosuvastatin Tablets [NEW] (USP41-NF36 1S)

Rosuvastatin Calcium [NEW] (USP41-NF36 1S)

Salicylic Acid Plaster (USP41-NF36 1S)

Sodium Thiosulfate (USP41-NF36 1S)

Sodium Thiosulfate Injection (USP41-NF36 1S)

Terazosin Tablets (USP41-NF36 1S)

Tocainide Hydrochloride (USP41-NF36 1S)

Tocainide Hydrochloride Tablets (USP41-NF36 1S)

Verapamil Hydrochloride Extended-Release Tablets (USP41-NF36 1S)

PF 43(2): Mar.-Apr. 2017 3

DIETARY SUPPLEMENT MONOGRAPHS

Carotenes [NEW] (USP41-NF36 1S)

European Elder Berry Dry Extract [NEW] (USP41-NF36 1S)

Flax Seed Oil (USP41-NF36 1S)

Powdered Decaffeinated Green Tea Extract (USP41-NF36 1S)

Valerian Root Dry Extract Capsules [NEW] (USP41-NF36 1S)

Valerian Root Powder Capsules [NEW] (USP41-NF36 1S)

Vitex negundo Leaf [NEW] (USP41-NF36 1S)

Vitex negundo Leaf Dry Extract [NEW] (USP41-NF36 1S)

Vitex negundo Leaf Powder [NEW] (USP41-NF36 1S)

NF MONOGRAPHS

Palm Oil (USP41-NF36 1S)

Polydextrose (USP41-NF36 1S)

Hydrogenated Vegetable Oil (USP41-NF36 1S)

Microcrystalline Wax (USP41-NF36 1S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

USP MONOGRAPHS

Edetate Calcium Disodium (USP41-NF36 1S)

Povidone (USP41-NF36 1S)

STIMULI TO THE REVISION PROCESS

Stimuli to The Revision Process

PF 43(2): Mar.-Apr. 2017 4

Table of Contents

PROPOSED IRA

Proposed Interim Revision Announcements

IN-PROCESS REVISION

In-Process Revision

GENERAL CHAPTERS

<381> ELASTOMERIC CLOSURES FOR INJECTIONS (USP41-NF36 1S)

<382> ELASTOMERIC CLOSURE FUNCTIONALITY IN INJECTABLE PHARMACEUTICAL

PACKAGING/DELIVERY SYSTEMS [NEW] (USP41-NF36 1S)

<660> CONTAINERS—GLASS (USP41-NF36 1S)

<665> POLYMERIC COMPONENTS AND SYSTEMS USED IN THE MANUFACTURING OF

PHARMACEUTICAL AND BIOPHARMACEUTICAL DRUG PRODUCTS [NEW] (USP41-NF36 1S)

<1168> COMPOUNDING FOR PHASE I INVESTIGATIONAL STUDIES [NEW] (USP41-NF36 1S)

<1381> ELASTOMERIC EVALUATION OF ELASTOMERIC COMPONENTS USED IN PHARMACEUTICAL

PACKAGING/DELIVERY SYSTEMS [NEW] (USP41-NF36 1S)

<1382> ASSESSMENT OF ELASTOMERIC CLOSURE FUNCTIONALITY IN INJECTABLE

PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS [NEW] (USP41-NF36 1S)

<1660> EVALUATION OF THE INNER SURFACE DURABILITY OF GLASS CONTAINERS (USP41-NF36

1S)

<1665> PLASTIC COMPONENTS AND SYSTEMS USED TO MANUFACTURE PHARMACEUTICAL

DRUG PRODUCTS [NEW] (USP41-NF36 1S)

<2040> DISINTEGRATION AND DISSOLUTION OF DIETARY SUPPLEMENTS (USP41-NF36 1S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Ammonium Hydrogen Difluoride [NEW] (USP41-NF36 1S)

Blood Group A1 Red Blood Cells and Blood Group B Red Blood Cells (USP41-NF36 1S)

Chloromethylnitroimidazole [NEW] (USP41-NF36 1S)

Dimethylcarbonate [NEW] (USP41-NF36 1S)

Dimidium Bromide [NEW] (USP41-NF36 1S)

Fluoroandrostadiene Carboxylic Acid [NEW] (USP41-NF36 1S)

Gadolinium Sulfate (USP41-NF36 1S)

Lithium Sulfate (USP41-NF36 1S)

Petroleum Ether [NEW] (USP41-NF36 1S)

Sulfan Blue [NEW] (USP41-NF36 1S)

n-Tricosane (USP41-NF36 1S)

Water, Ammonia-Free (USP41-NF36 1S)

Test Solutions

PF 43(3): May-Jun. 2017 1

0.1 N Sodium Chloride TS [NEW] (USP41-NF36 1S)

10 N Sulfuric Acid TS [NEW] (USP41-NF36 1S)

Volumetric Solutions

0.01 M Sodium Thiosulfate VS (USP41-NF36 1S)

Chromatographic Columns

L86 (USP41-NF36 1S)

L112 [NEW] (USP41-NF36 1S)

REFERENCE TABLES

Container Specifications

Container Specifications [NEW] (USP41-NF36 1S)

Description and Solubility

Description and Relative Solubility of USP and NF Articles [NEW] (USP41-NF36 1S)

Description and Solubility - B

Description and Solubility - D

Description and Solubility - E

Description and Solubility - M

USP MONOGRAPHS

Acetaminophen Tablets (USP41-NF36 1S)

Amitriptyline Hydrochloride (USP41-NF36 1S)

Amitriptyline Hydrochloride Injection (USP41-NF36 1S)

Amitriptyline Hydrochloride Tablets (USP41-NF36 1S)

Amoxicillin (USP41-NF36 1S)

Anthrax Vaccine Adsorbed (USP41-NF36 1S)

Azathioprine Tablets (USP41-NF36 1S)

Azelastine Hydrochloride Ophthalmic Solution [NEW] (USP41-NF36 1S)

Azithromycin (USP41-NF36 1S)

Azithromycin Tablets (USP41-NF36 1S)

Benzphetamine Hydrochloride [NEW] (USP41-NF36 1S)

Benzphetamine Hydrochloride Tablets [NEW] (USP41-NF36 1S)

Carbidopa and Levodopa Extended-Release Tablets (USP41-NF36 1S)

Carprofen (USP41-NF36 1S)

Celecoxib Capsules [NEW] (USP41-NF36 1S)

Deferasirox [NEW] (USP41-NF36 1S)

Desmopressin Acetate (USP41-NF36 1S)

Dexamethasone Ophthalmic Suspension (USP41-NF36 1S)

Dexamethasone Sodium Phosphate Injection (USP41-NF36 1S)

Dihydrocodeine Bitartrate (USP41-NF36 1S)

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution (USP41-NF36 1S)

Eletriptan Hydrobromide [NEW] (USP41-NF36 1S)

Epinephrine Injection (USP41-NF36 1S)

Estradiol Benzoate (USP41-NF36 1S)

PF 43(3): May-Jun. 2017 2

Estriol (USP41-NF36 1S)

Ethotoin (USP41-NF36 1S)

Ethotoin Tablets (USP41-NF36 1S)

Fludeoxyglucose F 18 Injection (USP41-NF36 1S)

Gentamicin Sulfate (USP41-NF36 1S)

Hydroxyzine Pamoate Oral Suspension (USP41-NF36 1S)

Imipenem (USP41-NF36 1S)

Lactulose [NEW] (USP41-NF36 1S)

Lidocaine (USP41-NF36 1S)

Lidocaine Hydrochloride (USP41-NF36 1S)

Lidocaine Hydrochloride Oral Topical Solution (USP41-NF36 1S)

Lidocaine Hydrochloride Topical Solution (USP41-NF36 1S)

Liothyronine Sodium (USP41-NF36 1S)

Maprotiline Hydrochloride (USP41-NF36 1S)

Mebendazole Tablets (USP41-NF36 1S)

Metaproterenol Sulfate Inhalation Aerosol (USP41-NF36 1S)

Methotrexate (USP41-NF36 1S)

Milnacipran Hydrochloride [NEW] (USP41-NF36 1S)

Milnacipran Hydrochloride Tablets [NEW] (USP41-NF36 1S)

Ammonia N 13 Injection (USP41-NF36 1S)

Octinoxate (USP41-NF36 1S)

Octisalate (USP41-NF36 1S)

Octocrylene (USP41-NF36 1S)

Omega-3-Acid Ethyl Esters Capsules (USP41-NF36 1S)

Phentolamine Mesylate (USP41-NF36 1S)

Pilocarpine Hydrochloride Tablets (USP41-NF36 1S)

Pravastatin Sodium (USP41-NF36 1S)

Promethazine and Phenylephrine Hydrochloride Oral Solution (USP41-NF36 1S)

Rizatriptan Benzoate Orally Disintegrating Tablets (USP41-NF36 1S)

Selenium Sulfide Topical Suspension (USP41-NF36 1S)

Somatropin (USP41-NF36 1S)

Sumatriptan Nasal Spray (USP41-NF36 1S)

Tacrolimus Ointment [NEW] (USP41-NF36 1S)

Taurine (USP41-NF36 1S)

Terbutaline Sulfate Inhalation Aerosol (USP41-NF36 1S)

Testosterone Enanthate (USP41-NF36 1S)

Testosterone Enanthate Injection (USP41-NF36 1S)

Tetracycline (USP41-NF36 1S)

Tetracycline Hydrochloride (USP41-NF36 1S)

Tetrahydrozoline Hydrochloride Ophthalmic Solution (USP41-NF36 1S)

Tiamulin (USP41-NF36 1S)

Tiamulin Fumarate (USP41-NF36 1S)

Trandolapril (USP41-NF36 1S)

Trazodone Hydrochloride Tablets (USP41-NF36 1S)

Triptorelin Pamoate [NEW] (USP41-NF36 1S)

Verapamil Hydrochloride Injection (USP41-NF36 1S)

Xylazine (USP41-NF36 1S)

PF 43(3): May-Jun. 2017 3

DIETARY SUPPLEMENT MONOGRAPHS

Ascorbic Acid Chewable Gels [NEW] (USP41-NF36 1S)

Cholecalciferol Chewable Gels [NEW] (USP41-NF36 1S)

Menaquinone-4 [NEW] (USP41-NF36 1S)

Methylcobalamin (USP41-NF36 1S)

Methylcobalamin Tablets (USP41-NF36 1S)

NF MONOGRAPHS

Squalane (USP41-NF36 1S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS

Applying the USP <905> Content Uniformity Zero Tolerance Criterion to Large Sample Sizes

Drug Products Containing Nanomaterials

PROPOSALS FOR DATA INTERPRETATION IN THE CONTEXT OF DETERMINATION OF

AERODYNAMIC PARTICLE SIZE DISTRIBUTION PROFILE FOR ORALLY INHALED PRODUCTS

PF 43(3): May-Jun. 2017 4

Table of Contents

PROPOSED IRA

Proposed Interim Revision Announcements

IN-PROCESS REVISION

In-Process Revision

GENERAL CHAPTERS

<5> Inhalation and Nasal Drug Products - General Information and Product Quality Tests

(USP41-NF36 2S)

<121> Insulin Assays (USP41-NF36 2S)

<856> Near-Infrared Spectroscopy [NEW] (USP41-NF36 2S)

<858> Raman Spectroscopy [NEW] (USP41-NF36 2S)

<861> Sutures - Diameter (USP41-NF36 2S)

<871> Sutures - Needle Attachment (USP41-NF36 2S)

<881> Tensile Strength (USP41-NF36 2S)

<1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products (USP41-NF36 2S)

<1099> Limit On Number of Large Deviations When Assessing Content Uniformity In Large

Samples [NEW] (USP41-NF36 2S)

<1119> Near-Infrared Spectroscopy (USP41-NF36 2S)

<1120> Raman Spectroscopy (USP41-NF36 2S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Ethyl p-Toluenesulfonate [NEW] (USP41-NF36 2S)

Packings for High-Pressure Liquid Chromatography (USP41-NF36 2S)

Phases for Gas Chromatography (USP41-NF36 2S)

Supports for Gas Chromatography (USP41-NF36 2S)

Chromatographic Columns

L111 [NEW] (USP41-NF36 2S)

L113 [NEW] (USP41-NF36 2S)

REFERENCE TABLES

Container Specifications

Container Specifications [NEW] (USP41-NF36 2S)

Description and Solubility

Description and Relative Solubility of USP and NF Articles (USP41-NF36 2S)

Description and Solubility - C

PF 43(4): Jul.-Aug. 2017 1

Description and Solubility - D

Description and Solubility - I

Description and Solubility - T

USP MONOGRAPHS

Acetazolamide (USP41-NF36 2S)

Amantadine Hydrochloride (USP41-NF36 2S)

Amantadine Hydrochloride Capsules (USP41-NF36 2S)

Amantadine Hydrochloride Oral Solution (USP41-NF36 2S)

Azithromycin for Oral Suspension (USP41-NF36 2S)

Bicalutamide Tablets (USP41-NF36 2S)

Captopril Tablets (USP41-NF36 2S)

Captopril and Hydrochlorothiazide Tablets (USP41-NF36 2S)

Carbinoxamine Maleate (USP41-NF36 2S)

Castor Oil (USP41-NF36 2S)

Cefazolin Sodium (USP41-NF36 2S)

Chlorzoxazone (USP41-NF36 2S)

Chlorzoxazone Tablets (USP41-NF36 2S)

Citalopram Oral Solution (USP41-NF36 2S)

Climbazole [NEW] (USP41-NF36 2S)

Clomiphene Citrate Tablets (USP41-NF36 2S)

Cromolyn Sodium (USP41-NF36 2S)

Cyclobenzaprine Hydrochloride (USP41-NF36 2S)

Diphenhydramine Hydrochloride Tablets [NEW] (USP41-NF36 2S)

Entecavir (USP41-NF36 2S)

Entecavir Oral Solution [NEW] (USP41-NF36 2S)

Epinephrine Inhalation Aerosol (USP41-NF36 2S)

Epinephrine Bitartrate Inhalation Aerosol (USP41-NF36 2S)

Escitalopram Tablets (USP41-NF36 2S)

Gabapentin (USP41-NF36 2S)

Gemcitabine Hydrochloride (USP41-NF36 2S)

Guanidine Hydrochloride [NEW] (USP41-NF36 2S)

Hyoscyamine Sulfate (USP41-NF36 2S)

Indomethacin (USP41-NF36 2S)

Isoetharine Mesylate Inhalation Aerosol (USP41-NF36 2S)

Isoproterenol Hydrochloride Inhalation Aerosol (USP41-NF36 2S)

Isoproterenol Hydrochloride and Phenylephrine Bitartrate Inhalation Aerosol (USP41-NF36 2S)

Loperamide Hydrochloride (USP41-NF36 2S)

Lopinavir and Ritonavir Oral Solution (USP41-NF36 2S)

Lopinavir and Ritonavir Tablets (USP41-NF36 2S)

Maprotiline Hydrochloride Tablets (USP41-NF36 2S)

Meloxicam Tablets (USP41-NF36 2S)

Methoxsalen (USP41-NF36 2S)

Methoxsalen Capsules (USP41-NF36 2S)

Methoxsalen Topical Solution (USP41-NF36 2S)

Methscopolamine Bromide (USP41-NF36 2S)

Methscopolamine Bromide Tablets (USP41-NF36 2S)

PF 43(4): Jul.-Aug. 2017 2

Metoprolol Tartrate Injection (USP41-NF36 2S)

Oxaliplatin for Injection (USP41-NF36 2S)

Pimobendan (USP41-NF36 2S)

Primaquine Phosphate (USP41-NF36 2S)

Protriptyline Hydrochloride (USP41-NF36 2S)

Ritonavir Capsules (USP41-NF36 2S)

Ritonavir Oral Solution (USP41-NF36 2S)

Ritonavir Tablets (USP41-NF36 2S)

Sodium Monofluorophosphate (USP41-NF36 2S)

Stavudine Capsules (USP41-NF36 2S)

Absorbable Surgical Suture (USP41-NF36 2S)

Nonabsorbable Surgical Suture (USP41-NF36 2S)

Testosterone Topical Solution [NEW] (USP41-NF36 2S)

Travoprost Ophthalmic Solution (USP41-NF36 2S)

Trichlormethiazide Tablets (USP41-NF36 2S)

Vinblastine Sulfate (USP41-NF36 2S)

DIETARY SUPPLEMENT MONOGRAPHS

Krill Oil (USP41-NF36 2S)

Sichuan Lovage Rhizome [NEW] (USP41-NF36 2S)

Sichuan Lovage Rhizome Powder [NEW] (USP41-NF36 2S)

NF MONOGRAPHS

Sodium Lauroyl Sarcosinate [NEW] (USP41-NF36 2S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS

Stimuli to The Revision Process

A Proposed In Vitro Insulin Cell-Based Bioassay to be Included in USP General Chapter Insulin

Assays <121>

USPC Responses to Comments On Stimuli Article "Modernization of Asbestos Testing in USP

Talc"

PF 43(4): Jul.-Aug. 2017 3

Table of Contents

PROPOSED IRA

Proposed Interim Revision Announcements

USP MONOGRAPHS

Diclofenac Sodium and Misoprostol Delayed-Release Tablets (1-Mar-2018)

DIETARY SUPPLEMENT MONOGRAPHS

Salix Species Bark (1-Mar-2018)

Salix Species Bark Dry Extract (1-Mar-2018)

Salix Species Bark Powder (1-Mar-2018)

NF MONOGRAPHS

Diethyl Sebacate (1-Mar-2018)

IN-PROCESS REVISION

In-Process Revision

GENERAL CHAPTERS

<630> Visual Comparison [NEW] (USP41-NF36 2S)

<785> Osmolality and Osmolarity (USP41-NF36 2S)

<855> Nephelometry, Turbidimetry, and Visual Comparison (USP41-NF36 2S)

<857> Ultraviolet-Visible Spectroscopy (USP41-NF36 2S)

<1211> Sterilization and Sterility Assurance of Compendial Articles (USP41-NF36 2S)

<1222> Terminally Sterilized Pharmaceutical Products - Parametric Release (USP41-NF36 2S)

<1228.4> Depyrogenation By Rinsing [NEW] (USP41-NF36 2S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Aluminum Oxide Strips [NEW] (USP41-NF36 2S)

Ammonium Tartrate [NEW] (USP41-NF36 2S)

Cellulose Diethylaminoethyl [NEW] (USP41-NF36 2S)

Diethyl Phthalate [NEW] (USP41-NF36 2S)

Indigo Carmine (USP41-NF36 2S)

Magnesium Carbonate [NEW] (USP41-NF36 2S)

p-Nitroaniline (USP41-NF36 2S)

Potassium Pyroantimonate (USP41-NF36 2S)

Sulfiram [NEW] (USP41-NF36 2S)

PF 43(5): Sep.-Oct. 2017 1

Trimethylamine Hydrochloride [NEW] (USP41-NF36 2S)

Indicators

Eriochrome Black T (USP41-NF36 2S)

REFERENCE TABLES

Container Specifications

Container Specifications [NEW] (USP41-NF36 2S)

Description and Solubility

Description and Relative Solubility of USP and NF Articles (USP41-NF36 2S)

Description and Solubility - D

Description and Solubility - G

Description and Solubility - P

Description and Solubility - R

USP MONOGRAPHS

Acarbose Tablets [NEW] (USP41-NF36 2S)

Acetaminophen and Codeine Phosphate Tablets (USP41-NF36 2S)

Atropine Sulfate (USP41-NF36 2S)

Azacitidine [NEW] (USP41-NF36 2S)

Bacitracin (USP41-NF36 2S)

Betahistine Hydrochloride (USP41-NF36 2S)

Biotin Compounded Oral Suspension [NEW] (USP41-NF36 2S)

Chlorothiazide Compounded Oral Suspension [NEW] (USP41-NF36 2S)

Cod Liver Oil (USP41-NF36 2S)

Cyclophosphamide Compounded Oral Suspension [NEW] (USP41-NF36 2S)

Desvenlafaxine [NEW] (USP41-NF36 2S)

Desvenlafaxine Fumarate [NEW] (USP41-NF36 2S)

Desvenlafaxine Succinate [NEW] (USP41-NF36 2S)

Dextromethorphan (USP41-NF36 2S)

Dextromethorphan Hydrobromide (USP41-NF36 2S)

Dichlorphenamide Tablets (USP41-NF36 2S)

Diphenhydramine Hydrochloride Capsules (USP41-NF36 2S)

Diphenhydramine Hydrochloride Oral Powder [NEW] (USP41-NF36 2S)

Diphenhydramine Hydrochloride Oral Solution (USP41-NF36 2S)

Diphenhydramine and Phenylephrine Hydrochlorides Tablets (USP41-NF36 2S)

Ephedrine (USP41-NF36 2S)

Ephedrine Sulfate (USP41-NF36 2S)

Eptacog Alfa Activated (USP41-NF36 2S)

Eptacog Alfa Activated for Injection (USP41-NF36 2S)

Exenatide Injection [NEW] (USP41-NF36 2S)

Fludarabine Phosphate (USP41-NF36 2S)

Fluvastatin Sodium (USP41-NF36 2S)

Fosinopril Sodium (USP41-NF36 2S)

Gadobutrol [NEW] (USP41-NF36 2S)

PF 43(5): Sep.-Oct. 2017 2

Guanabenz Acetate Tablets (USP41-NF36 2S)

Iscotrizinol [NEW] (USP41-NF36 2S)

Isotretinoin Capsules (USP41-NF36 2S)

Ivermectin Compounded Oral Solution, Veterinary [NEW] (USP41-NF36 2S)

Lansoprazole Delayed-Release Capsules (USP41-NF36 2S)

Leflunomide Compounded Oral Suspension [NEW] (USP41-NF36 2S)

Loratadine Orally-Disintegrating Tablets (USP41-NF36 2S)

Mirtazapine Compounded Oral Suspension, Veterinary [NEW] (USP41-NF36 2S)

Naproxen Sodium and Pseudoephedrine Hydrochloride Extended-Release Tablets [NEW] (USP41-

NF36 2S)

Orlistat Capsules (USP41-NF36 2S)

Phenylephrine Hydrochloride Injection (USP41-NF36 2S)

Phenylephrine Hydrochloride Tablets (USP41-NF36 2S)

Phytonadione (USP41-NF36 2S)

Polidocanol [NEW] (USP41-NF36 2S)

Prazosin Hydrochloride Capsules (USP41-NF36 2S)

Prazosin Hydrochloride Compounded Oral Suspension [NEW] (USP41-NF36 2S)

Propafenone Hydrochloride Tablets (USP41-NF36 2S)

Pseudoephedrine Hydrochloride Tablets (USP41-NF36 2S)

Rotigotine [NEW] (USP41-NF36 2S)

Rotigotine Transdermal System [NEW] (USP41-NF36 2S)

Scaffold Human Amniotic Membrane Allograft [NEW] (USP41-NF36 2S)

Sennosides (USP41-NF36 2S)

Sotalol Hydrochloride (USP41-NF36 2S)

Torsemide Tablets (USP41-NF36 2S)

Triamcinolone Acetonide (USP41-NF36 2S)

Triamcinolone Acetonide Ointment (USP41-NF36 2S)

Urea Compounded Irrigation [NEW] (USP41-NF36 2S)

Vigabatrin (USP41-NF36 2S)

DIETARY SUPPLEMENT MONOGRAPHS

L-Alpha-Glycerylphosphorylcholine [NEW] (USP41-NF36 2S)

Cod Liver Oil Capsules (USP41-NF36 2S)

Dong Quai Root [NEW] (USP41-NF36 2S)

Dong Quai Root Powder [NEW] (USP41-NF36 2S)

NF MONOGRAPHS

Dextrose Excipient (USP41-NF36 2S)

Fumaric Acid (USP41-NF36 2S)

Maleic Acid (USP41-NF36 2S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

PF 43(5): Sep.-Oct. 2017 3

GENERAL CHAPTERS

<621> Chromatography [NEW] (USP41-NF36 2S)

NF MONOGRAPHS

Sodium Lauryl Sulfate

Wheat Starch

STIMULI TO THE REVISION PROCESS

Stimuli to The Revision Process

Assessment of Drug Product Performance - Bioavailability, Bioequivalence, and Dissolution

<1090>: Status Update

Considerations for Possible Revision to Align All USP Uniformity Requirements

Determination of Heat of Fusion of USP Melting Point Standards By Differential Scanning

Calorimetry

Evaluation of Screening Technologies for Assessing Medicines Quality

The Future of Normality In USP-NF

The Rationale and Proposed Changes to the Revision of Elastomeric Closures for Injections

<381>

The Development of Compendial Rapid Sterility Tests

PF 43(5): Sep.-Oct. 2017 4

Table of Contents

PROPOSED IRA

Proposed Interim Revision Announcements

IN-PROCESS REVISION

In-Process Revision

GENERAL CHAPTERS

<197> Spectrophotometric Identification Tests (USP42-NF37)

<476> Organic Impurities In Drug Substances and Drug Products (USP42-NF37)

<1086> Impurities In Drug Substances and Drug Products (USP42-NF37)

<1217> Tablet Breaking Force (USP42-NF37)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

N-Benzylacetamide [NEW] (USP42-NF37)

Glucoamylase [NEW] (USP42-NF37)

Glucose Oxidase [NEW] (USP42-NF37)

Glyoxal Solution [NEW] (USP42-NF37)

Peroxidase [NEW] (USP42-NF37)

Propylene Glycol [NEW] (USP42-NF37)

Sodium Phosphate, Tribasic, Anhydrous [NEW] (USP42-NF37)

Triacetin [NEW] (USP42-NF37)

Zinc Chloride, Anhydrous, Powdered (USP42-NF37)

Indicators

Oracet Blue B (USP42-NF37)

Test Solutions

Oracet Blue B TS (USP42-NF37)

Volumetric Solutions

0.02 M Edetate Disodium VS [NEW] (USP42-NF37)

0.01 N Hydrochloric Acid VS [NEW] (USP42-NF37)

0.01 M Lead Nitrate VS (USP42-NF37)

0.05 N Silver Nitrate VS (USP42-NF37)

0.025 N Sodium Hydroxide VS [NEW] (USP42-NF37)

0.002 N Sodium Thiosulfate VS [NEW] (USP42-NF37)

0.01 N Sulfuric Acid VS [NEW] (USP42-NF37)

0.05 N Sulfuric Acid VS (USP42-NF37)

0.02 M Zinc Sulfate VS [NEW] (USP42-NF37)

PF 43(6): Nov.-Dec. 2017 1

REFERENCE TABLES

Container Specifications

Container Specifications [NEW] (USP42-NF37)

Description and Solubility

Description and Relative Solubility of USP and NF Articles [NEW] (USP42-NF37)

Description and Solubility - L

Description and Solubility - N

Description and Solubility - P

USP MONOGRAPHS

Altretamine (USP42-NF37)

Altretamine Capsules (USP42-NF37)

Beta Carotene Capsules (USP42-NF37)

Betaxolol Hydrochloride (USP42-NF37)

Betaxolol Tablets (USP42-NF37)

Bromocriptine Mesylate Capsules (USP42-NF37)

Bumetanide Tablets (USP42-NF37)

Caffeine Citrate Injection (USP42-NF37)

Calcipotriene Topical Solution [NEW] (USP42-NF37)

Calcitriol (USP42-NF37)

Cefepime Hydrochloride (USP42-NF37)

Cefotetan for Injection (USP42-NF37)

Cefotetan Disodium (USP42-NF37)

Cefprozil (USP42-NF37)

Celecoxib (USP42-NF37)

Cephalexin (USP42-NF37)

Cephalexin Capsules (USP42-NF37)

Cephalexin for Oral Suspension (USP42-NF37)

Cytarabine (USP42-NF37)

Dexamethasone Elixir (USP42-NF37)

Dexamethasone Oral Solution (USP42-NF37)

Dexamethasone Sodium Phosphate Ophthalmic Solution (USP42-NF37)

Dichlorphenamide (USP42-NF37)

Dicyclomine Hydrochloride (USP42-NF37)

Dicyclomine Hydrochloride Capsules (USP42-NF37)

Dicyclomine Hydrochloride Injection (USP42-NF37)

Dicyclomine Hydrochloride Oral Solution (USP42-NF37)

Dicyclomine Hydrochloride Tablets (USP42-NF37)

Disulfiram (USP42-NF37)

Disulfiram Tablets (USP42-NF37)

Dobutamine Hydrochloride (USP42-NF37)

Doxycycline Hyclate Delayed-Release Tablets (USP42-NF37)

Emetine Hydrochloride (USP42-NF37)

Emetine Hydrochloride Injection (USP42-NF37)

Erythromycin Ethylsuccinate and Sulfisoxazole Acetyl for Oral Suspension (USP42-NF37)

Ethambutol Hydrochloride (USP42-NF37)

PF 43(6): Nov.-Dec. 2017 2

Felodipine Extended-Release Tablets (USP42-NF37)

Fenofibrate Capsules (USP42-NF37)

Fenofibrate Tablets (USP42-NF37)

Fexofenadine Hydrochloride Oral Suspension [NEW] (USP42-NF37)

Fingolimod Hydrochloride (USP42-NF37)

Fluconazole (USP42-NF37)

Fluorescein Injection (USP42-NF37)

Fluoxetine Hydrochloride (USP42-NF37)

Hard Gelatin Capsule Shell (USP42-NF37)

Guaifenesin Compounded Injection, Veterinary [NEW] (USP42-NF37)

Histidine (USP42-NF37)

Ifosfamide (USP42-NF37)

Ifosfamide Injection [NEW] (USP42-NF37)

Ifosfamide for Injection (USP42-NF37)

Itraconazole Capsules [NEW] (USP42-NF37)

Lacosamide [NEW] (USP42-NF37)

Lacosamide Injection [NEW] (USP42-NF37)

Lacosamide Oral Solution [NEW] (USP42-NF37)

Lacosamide Tablets [NEW] (USP42-NF37)

Lidocaine Ointment (USP42-NF37)

Lidocaine Hydrochloride Jelly (USP42-NF37)

Magnesium Oxide (USP42-NF37)

Magnesium Oxide Capsules (USP42-NF37)

Magnesium Oxide Tablets (USP42-NF37)

Mycophenolate Mofetil for Injection (USP42-NF37)

Mycophenolate Mofetil for Oral Suspension (USP42-NF37)

Naltrexone Hydrochloride (USP42-NF37)

Nisoldipine [NEW] (USP42-NF37)

Norethindrone and Ethinyl Estradiol Tablets (USP42-NF37)

Norgestrel (USP42-NF37)

Oxazepam Capsules (USP42-NF37)

Oxycodone Hydrochloride (USP42-NF37)

Paroxetine Hydrochloride (USP42-NF37)

Phenmetrazine Hydrochloride (USP42-NF37)

Phenmetrazine Hydrochloride Tablets (USP42-NF37)

Progesterone (USP42-NF37)

Progesterone Injection (USP42-NF37)

Propranolol Hydrochloride (USP42-NF37)

Propranolol Hydrochloride Tablets (USP42-NF37)

Sulfamethoxazole (USP42-NF37)

Temozolomide for Injection (USP42-NF37)

Tranexamic Acid Tablets [NEW] (USP42-NF37)

Crystallized Trypsin (USP42-NF37)

Vincristine Sulfate (USP42-NF37)

Witch Hazel (USP42-NF37)

Zinc Oxide Ointment (USP42-NF37)

Zinc Oxide Paste (USP42-NF37)

PF 43(6): Nov.-Dec. 2017 3

GLOBAL HEALTH MONOGRAPHS

Chlorhexidine Gluconate Topical Gel (USP42-NF37)

DIETARY SUPPLEMENT MONOGRAPHS

Eleuthero Root and Rhizome Dry Extract Capsules (USP42-NF37)

Eleuthero Root and Rhizome Dry Extract Tablets (USP42-NF37)

Rhodiola Rosea Capsules (USP42-NF37)

Rhodiola Rosea Tablets (USP42-NF37)

Vitamins With Minerals Oral Powder [NEW] (USP42-NF37)

EXCIPIENTS

USP and NF Excipients, Listed By Category (USP42-NF37)

Briefing

Introduction

Emulsifying Agent

Flavors and Fragrance

Solvent

Sweetening Agent

NF MONOGRAPHS

Low-Substituted Carboxymethylcellulose Sodium (USP42-NF37)

Neohesperidin Dihyrochalcone [NEW] (USP42-NF37)

Propylene Glycol Diacetate [NEW] (USP42-NF37)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS

Stimuli to The Revision Process

Higher Order Structure of Proteins In Biopharmaceutical Development

Proceedings of The Workshop On Lifecycle Approach of Analytical Procedures

PF 43(6): Nov.-Dec. 2017 4

Table of Contents

PROPOSED IRA

Proposed Interim Revision Announcements

IN-PROCESS REVISION

In-Process Revision

GENERAL NOTICES FOR USP-NF

General Notices to USP-NF (USP42-NF37)

1. TITLE AND REVISION

2. OFFICIAL STATUS AND LEGAL RECOGNITION

3. CONFORMANCE TO STANDARDS

4. MONOGRAPHS AND GENERAL CHAPTERS

5. MONOGRAPH COMPONENTS

6. TESTING PRACTICES AND PROCEDURES

7. TEST RESULTS

8. TERMS AND DEFINITIONS

9. PRESCRIBING AND DISPENSING

10. PRESERVATION, PACKAGING, STORAGE, AND LABELING

GENERAL CHAPTERS

<7> LABELING (USP42-NF37)

<561> ARTICLES OF BOTANICAL ORIGIN (USP42-NF37)

<1057> BIOTECHNOLOGY-DERIVED ARTICLES—TOTAL PROTEIN ASSAY (USP42-NF37)

<1160> PHARMACEUTICAL CALCULATIONS IN PHARMACY PRACTICE (USP42-NF37)

<1176> PRESCRIPTION BALANCES AND VOLUMETRIC APPARATUS USED IN COMPOUNDING

(USP42-NF37)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Aflatoxin B1 [NEW] (USP42-NF37)

Aflatoxin B2 [NEW] (USP42-NF37)

Aflatoxin G1 [NEW] (USP42-NF37)

Aflatoxin G2 [NEW] (USP42-NF37)

Clozapine N-Oxide [NEW] (USP42-NF37)

Deuterated Ethanol [NEW] (USP42-NF37)

Deuterium Chloride Solution [NEW] (USP42-NF37)

Deuterium Oxide (USP42-NF37)

Isobutyl Chloroformate [NEW] (USP42-NF37)

Polyethylene Glycol 400 [NEW] (USP42-NF37)

PF 44(1): Jan.-Feb. 2018 1

Polyethylene Glycol 4000 [NEW] (USP42-NF37)

Pyridine, Anhydrous [NEW] (USP42-NF37)

Trifluoroacetic Acid Ethyl Ester [NEW] (USP42-NF37)

Test Solutions

Citric Acid TS [NEW] (USP42-NF37)

Sodium Chloride TS [NEW] (USP42-NF37)

Volumetric Solutions

0.2 N Alcoholic Potassium Hydroxide VS [NEW] (USP42-NF37)

0.002 M Edetate Disodium VS [NEW] (USP42-NF37)

0.01 M Edetate Disodium VS [NEW] (USP42-NF37)

REFERENCE TABLES

Container Specifications

Container Specifications [NEW] (USP42-NF37)

Description and Solubility

Description and Relative Solubility of USP and NF Articles [NEW] (USP42-NF37)

Description and Solubility - G

USP MONOGRAPHS

Albuterol Inhalation Aerosol [NEW] (USP42-NF37)

Ampicillin and Sulbactam for Injection (USP42-NF37)

Atomoxetine Capsules (USP42-NF37)

Bendroflumethiazide (USP42-NF37)

Benzonatate (USP42-NF37)

Betamethasone (USP42-NF37)

Bisacodyl (USP42-NF37)

Bumetanide (USP42-NF37)

Bumetanide Injection (USP42-NF37)

Carbidopa and Levodopa Orally Disintegrating Tablets (USP42-NF37)

Cefixime (USP42-NF37)

Cefixime Capsules [NEW] (USP42-NF37)

Cefixime for Oral Suspension (USP42-NF37)

Cefixime Tablets (USP42-NF37)

Chromium Cr 51 Edetate Injection (USP42-NF37)

Desvenlafaxine Extended-Release Tablets [NEW] (USP42-NF37)

Diclofenac Sodium Topical Solution [NEW] (USP42-NF37)

Ertapenem Sodium [NEW] (USP42-NF37)

Ethosuximide (USP42-NF37)

Ethosuximide Capsules (USP42-NF37)

Ethosuximide Oral Solution (USP42-NF37)

Famciclovir Tablets [NEW] (USP42-NF37)

Fentanyl (USP42-NF37)

Fentanyl Citrate Compounded Injection [NEW] (USP42-NF37)

PF 44(1): Jan.-Feb. 2018 2

Fentanyl Citrate and Bupivacaine Hydrochloride Compounded Injection [NEW] (USP42-NF37)

Fentanyl Citrate and Ropivacaine Hydrochloride Compounded Injection [NEW] (USP42-NF37)

Heparin Lock Flush Solution (USP42-NF37)

Heparin Sodium Injection (USP42-NF37)

Hydrochlorothiazide Capsules (USP42-NF37)

Hydromorphone Hydrochloride (USP42-NF37)

Hypromellose Capsule Shell (USP42-NF37)

Inamrinone Injection (USP42-NF37)

Indium In 111 Ibritumomab Tiuxetan Injection (USP42-NF37)

Indium In 111 Satumomab Pendetide Injection (USP42-NF37)

Insulin (USP42-NF37)

Iobenguane I 131 Injection (USP42-NF37)

Iodohippurate Sodium I 123 Injection (USP42-NF37)

Iodohippurate Sodium I 131 Injection (USP42-NF37)

Rose Bengal Sodium I 131 Injection (USP42-NF37)

Levalbuterol Inhalation Solution (USP42-NF37)

Levalbuterol Hydrochloride (USP42-NF37)

Lovastatin Tablets (USP42-NF37)

Magnesium Hydroxide (USP42-NF37)

Metaraminol Bitartrate (USP42-NF37)

Mitoxantrone Injection (USP42-NF37)

Mitoxantrone Hydrochloride (USP42-NF37)

Nicotine Polacrilex (USP42-NF37)

Orphenadrine Citrate Injection (USP42-NF37)

Orphenadrine Citrate Extended-Release Tablets (USP42-NF37)

Oxazepam (USP42-NF37)

Phenylephrine Hydrochloride Nasal Solution (USP42-NF37)

Phenylephrine Hydrochloride Ophthalmic Solution (USP42-NF37)

Chromic Phosphate P 32 Suspension (USP42-NF37)

Sodium Phosphate P 32 Solution (USP42-NF37)

Pramipexole Dihydrochloride Tablets [NEW] (USP42-NF37)

Primidone Tablets (USP42-NF37)

Propranolol Hydrochloride Injection (USP42-NF37)

Pyridostigmine Bromide (USP42-NF37)

Risperidone Orally Disintegrating Tablets (USP42-NF37)

Salicylic Acid Gel (USP42-NF37)

Sertraline Hydrochloride Tablets (USP42-NF37)

Suprofen (USP42-NF37)

Suprofen Ophthalmic Solution (USP42-NF37)

Technetium Tc 99m Albumin Injection (USP42-NF37)

Technetium Tc 99m Albumin Colloid Injection (USP42-NF37)

Technetium Tc 99m Apcitide Injection (USP42-NF37)

Technetium Tc 99m Arcitumomab Injection (USP42-NF37)

Technetium Tc 99m Depreotide Injection (USP42-NF37)

Technetium Tc 99m Etidronate Injection (USP42-NF37)

Technetium 99mTc Fanolesomab Injection (USP42-NF37)

Technetium Tc 99m Gluceptate Injection (USP42-NF37)

Technetium Tc 99m Lidofenin Injection (USP42-NF37)

PF 44(1): Jan.-Feb. 2018 3

Technetium Tc 99m Nofetumomab Merpentan Injection (USP42-NF37)

Terbutaline Sulfate (USP42-NF37)

Terbutaline Sulfate Injection (USP42-NF37)

Terbutaline Sulfate Tablets (USP42-NF37)

Triamcinolone Acetonide Nasal Spray (USP42-NF37)

Valproic Acid Oral Solution (USP42-NF37)

Xenon Xe 127 (USP42-NF37)

Xenon Xe 133 Injection (USP42-NF37)

DIETARY SUPPLEMENT MONOGRAPHS

Ashwagandha Root (USP42-NF37)

Powdered Ashwagandha Root (USP42-NF37)

Powdered Ashwagandha Root Extract (USP42-NF37)

Bitter Orange Fruit Flavonoids Dry Extract [NEW] (USP42-NF37)

Krill Oil Capsules (USP42-NF37)

Krill Oil Delayed-Release Capsules (USP42-NF37)

Lycopene (USP42-NF37)

Lycopene Preparation (USP42-NF37)

Tomato Extract Containing Lycopene (USP42-NF37)

Tienchi Ginseng Root and Rhizome (USP42-NF37)

Tienchi Ginseng Root and Rhizome Powder (USP42-NF37)

Tienchi Ginseng Root and Rhizome Powder Capsules (USP42-NF37)

Tienchi Ginseng Root and Rhizome Powder Tablets (USP42-NF37)

Tienchi Ginseng Root and Rhizome Dry Extract (USP42-NF37)

Tienchi Ginseng Root and Rhizome Dry Extract Capsules (USP42-NF37)

Tienchi Ginseng Root and Rhizome Dry Extract Tablets (USP42-NF37)

NF MONOGRAPHS

Butylated Hydroxyanisole (USP42-NF37)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

GENERAL CHAPTERS

<1055> BIOTECHNOLOGY-DERIVED ARTICLES—PEPTIDE MAPPING

STIMULI TO THE REVISION PROCESS

Measurement Uncertainty for the Pharmaceutical Industry

PF 44(1): Jan.-Feb. 2018 4

Table of Contents

PROPOSED IRA

Proposed Interim Revision Announcements

IN-PROCESS REVISION

In-Process Revision

GENERAL CHAPTERS

<2> ORAL DRUG PRODUCTS-PRODUCT QUALITY TESTS (USP42-NF37 1S)

<41> BALANCES (USP42-NF37 1S)

<701> DISINTEGRATION (USP42-NF37 1S)

<729> GLOBULE SIZE DISTRIBUTION IN LIPID INJECTABLE EMULSIONS (USP42-NF37 1S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Octylamine [NEW] (USP42-NF37 1S)

Poly(dimethylsiloxane-co-methylphenylsiloxane) [NEW] (USP42-NF37 1S)

Silica Gel, Precoated Plates, with Fluorescence Indicator F254 [NEW] (USP42-NF37 1S)

Sodium 1-Heptanesulfonate Monohydrate (USP42-NF37 1S)

Tryptamine Hydrochloride [NEW] (USP42-NF37 1S)

Test Solutions

1 M Phosphoric Acid TS [NEW] (USP42-NF37 1S)

Volumetric Solutions

0.1 N Potassium Arsenite VS (USP42-NF37 1S)

0.1 N Sodium Hydroxide VS (USP42-NF37 1S)

Chromatographic Columns

G50 [NEW] (USP42-NF37 1S)

L87 (USP42-NF37 1S)

L117 [NEW] (USP42-NF37 1S)

REFERENCE TABLES

Container Specifications

Container Specifications [NEW] (USP42-NF37)

Description and Solubility

Description and Relative Solubility of USP and NF Articles (USP42-NF37 1S)

Description and Solubility - A

PF 44(2): Mar.-Apr. 2018 1

Description and Solubility - C

Description and Solubility - F

Description and Solubility - N

Description and Solubility - S

USP MONOGRAPHS

Allopurinol Compounded Oral Suspension (USP42-NF37 1S)

Aminoglutethimide (USP42-NF37 1S)

Aminoglutethimide Tablets (USP42-NF37 1S)

Aminosalicylate Sodium (USP42-NF37 1S)

Aminosalicylate Sodium Tablets (USP42-NF37 1S)

Aminosalicylic Acid Tablets (USP42-NF37 1S)

Amlodipine and Olmesartan Medoxomil Tablets [NEW] (USP42-NF37 1S)

Azithromycin for Injection (USP42-NF37 1S)

Benazepril Hydrochloride Tablets (USP42-NF37 1S)

Bivalirudin [NEW] (USP42-NF37 1S)

Bivalirudin for Injection [NEW] (USP42-NF37 1S)

Cefepime for Injection (USP42-NF37 1S)

Chlorothiazide Sodium for Injection (USP42-NF37 1S)

Cholecalciferol Capsules (USP42-NF37 1S)

Clindamycin Injection (USP42-NF37 1S)

Clindamycin Hydrochloride Capsules (USP42-NF37 1S)

Clindamycin Hydrochloride Compounded Oral Solution [NEW] (USP42-NF37 1S)

Clindamycin Hydrochloride Oral Solution (USP42-NF37 1S)

Clindamycin Phosphate Topical Solution (USP42-NF37 1S)

Clindamycin Phosphate Vaginal Inserts (USP42-NF37 1S)

Clobetasol Propionate Ointment (USP42-NF37 1S)

Dacarbazine (USP42-NF37 1S)

Dacarbazine for Injection (USP42-NF37 1S)

Desmopressin Acetate (USP42-NF37 1S)

Desoximetasone (USP42-NF37 1S)

Doxycycline (USP42-NF37 1S)

Doxycycline Hyclate (USP42-NF37 1S)

Ephedrine Hydrochloride (USP42-NF37 1S)

Epoprostenol Sodium [NEW] (USP42-NF37 1S)

Epoprostenol for Injection [NEW] (USP42-NF37 1S)

Ergocalciferol Capsules (USP42-NF37 1S)

Ergoloid Mesylates Sublingual Tablets (USP42-NF37 1S)

Ergotamine Tartrate Sublingual Tablets (USP42-NF37 1S)

Escitalopram Oral Solution (USP42-NF37 1S)

Fosfomycin Tromethamine (USP42-NF37 1S)

Glycopyrrolate Tablets (USP42-NF37 1S)

Gonadorelin Acetate (USP42-NF37 1S)

Hydroxychloroquine Sulfate (USP42-NF37 1S)

Lamotrigine Tablets for Oral Suspension (USP42-NF37 1S)

Loracarbef Capsules (USP42-NF37 1S)

Loracarbef for Oral Suspension (USP42-NF37 1S)

PF 44(2): Mar.-Apr. 2018 2

Magnesium Carbonate (USP42-NF37 1S)

Magnesium Trisilicate (USP42-NF37 1S)

Manganese Chloride for Oral Solution (USP42-NF37 1S)

Manganese Sulfate Injection (USP42-NF37 1S)

Meclocycline Sulfosalicylate (USP42-NF37 1S)

Meclocycline Sulfosalicylate Cream (USP42-NF37 1S)

Mephenytoin (USP42-NF37 1S)

Mephenytoin Tablets (USP42-NF37 1S)

Meprednisone (USP42-NF37 1S)

Meprobamate Oral Suspension (USP42-NF37 1S)

Mesoridazine Besylate (USP42-NF37 1S)

Mesoridazine Besylate Injection (USP42-NF37 1S)

Mesoridazine Besylate Tablets (USP42-NF37 1S)

Metaproterenol Sulfate Inhalation Solution (USP42-NF37 1S)

Methacycline Hydrochloride Capsules (USP42-NF37 1S)

Methdilazine Hydrochloride (USP42-NF37 1S)

Methdilazine Hydrochloride Oral Solution (USP42-NF37 1S)

Methdilazine Hydrochloride Tablets (USP42-NF37 1S)

Methenamine Oral Solution (USP42-NF37 1S)

Methenamine Mandelate for Oral Solution (USP42-NF37 1S)

Methenamine Mandelate Oral Suspension (USP42-NF37 1S)

Methenamine Mandelate Delayed-Release Tablets (USP42-NF37 1S)

Minoxidil (USP42-NF37 1S)

Minoxidil Tablets (USP42-NF37 1S)

Naltrexone Hydrochloride Tablets (USP42-NF37 1S)

Oxaprozin (USP42-NF37 1S)

Phytonadione Compounded Oral Suspension [NEW] (USP42-NF37 1S)

Prochlorperazine Maleate Tablets (USP42-NF37 1S)

Pyridostigmine Bromide Oral Solution (USP42-NF37 1S)

Pyridostigmine Bromide Extended-Release Tablets [NEW] (USP42-NF37 1S)

Ropinirole Tablets (USP42-NF37 1S)

Saccharin Calcium (USP42-NF37 1S)

Saccharin Sodium (USP42-NF37 1S)

Sisomicin Sulfate (USP42-NF37 1S)

Sisomicin Sulfate Injection (USP42-NF37 1S)

Sodium Phenylbutyrate Oral Powder [NEW] (USP42-NF37 1S)

Sodium Phenylbutyrate Tablets [NEW] (USP42-NF37 1S)

Sodium Thiosulfate (USP42-NF37 1S)

Spironolactone (USP42-NF37 1S)

Spironolactone Tablets (USP42-NF37 1S)

Succinylcholine Chloride (USP42-NF37 1S)

Testosterone Cypionate (USP42-NF37 1S)

Testosterone Cypionate Injection (USP42-NF37 1S)

Tiagabine Hydrochloride (USP42-NF37 1S)

Triamterene and Hydrochlorothiazide Capsules (USP42-NF37 1S)

Vancomycin Hydrochloride Compounded Oral Solution [NEW] (USP42-NF37 1S)

Vitamin A (USP42-NF37 1S)

Vitamin A Capsules (USP42-NF37 1S)

PF 44(2): Mar.-Apr. 2018 3

Vitamin A Oral Liquid Preparation (USP42-NF37 1S)

Vitamin A Tablets (USP42-NF37 1S)

Vitamin E (USP42-NF37 1S)

Vitamin E Capsules (USP42-NF37 1S)

Vitamin E Preparation (USP42-NF37 1S)

Zolmitriptan (USP42-NF37 1S)

DIETARY SUPPLEMENT MONOGRAPHS

Chinese Skullcap Root [NEW] (USP42-NF37 1S)

Chinese Skullcap Root Powder [NEW] (USP42-NF37 1S)

Chinese Skullcap Root Dry Extract [NEW] (USP42-NF37 1S)

Chrysanthemum Flower [NEW] (USP42-NF37 1S)

Chrysanthemum Flower Powder [NEW] (USP42-NF37 1S)

Chrysanthemum Flower Dry Extract [NEW] (USP42-NF37 1S)

Wild Chrysanthemum Flower [NEW] (USP42-NF37 1S)

Wild Chrysanthemum Flower Powder [NEW] (USP42-NF37 1S)

Wild Chrysanthemum Flower Dry Extract [NEW] (USP42-NF37 1S)

Ginkgo Capsules (USP42-NF37 1S)

Ginkgo Tablets (USP42-NF37 1S)

Guarana Seed [NEW] (USP42-NF37 1S)

Guarana Seed Powder [NEW] (USP42-NF37 1S)

Guarana Seed Dry Extract [NEW] (USP42-NF37 1S)

Conjugated Linoleic Acids-Triglycerides [NEW] (USP42-NF37 1S)

EXCIPIENTS

USP and NF Excipients, Listed By Category [NEW] (USP42-NF37 1S)

Briefing

Introduction

Flavors and Fragrance

NF MONOGRAPHS

Anise Oil (USP42-NF37 1S)

Potassium Sorbate (USP42-NF37 1S)

Saccharin (USP42-NF37 1S)

Sorbic Acid (USP42-NF37 1S)

Star Anise Oil [NEW] (USP42-NF37 1S)

STAGE 4 HARMONIZATION

Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS

PF 44(2): Mar.-Apr. 2018 4

Table of Contents

PROPOSED IRA

Proposed Interim Revision Announcements

IN-PROCESS REVISION

In-Process Revision

GENERAL CHAPTERS

<64> PROBIOTIC TESTS [NEW] (USP42-NF37 1S)

<671> CONTAINERS-PERFORMANCE TESTING (USP42-NF37 1S)

<795> PHARMACEUTICAL COMPOUNDING-NONSTERILE PREPARATIONS (USP42-NF37 1S)

<1151> PHARMACEUTICAL DOSAGE FORMS (USP42-NF37 1S)

<1226> VERIFICATION OF COMPENDIAL PROCEDURES (USP42-NF37 1S)

<1671> THE APPLICATION OF MOISTURE VAPOR TRANSMISSION RATES FOR SOLID ORAL

DOSAGE FORMS IN PLASTIC PACKAGING SYSTEMS [NEW] (USP42-NF37 1S)

<1850> EVALUATION OF SCREENING TECHNOLOGIES FOR ASSESSING MEDICINE QUALITY [NEW]

(USP42-NF37 1S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

2-Acetylresorcinol [NEW] (USP42-NF37 1S)

(p-tert-Octylphenoxy) nonaethoxyethanol (USP42-NF37 1S)

Indicators

Eriochrome Black T (USP42-NF37 1S)

Indicator Test Papers

Litmus Paper, Neutral [NEW] (USP42-NF37 1S)

Test Solutions

0.2% Phosphoric Acid TS [NEW] (USP42-NF37 1S)

Volumetric Solutions

0.1 N Ammonium Thiocyanate VS (USP42-NF37 1S)

0.02 M Zinc Sulfate VS [NEW] (USP42-NF37 1S)

Chromatographic Columns

G51 [NEW] (USP42-NF37 1S)

L86 (USP42-NF37 1S)

L118 [NEW] (USP42-NF37 1S)

PF 44(3): May.-Jun. 2018 1

REFERENCE TABLES

Container Specifications

Container Specifications [NEW] (USP42-NF37 1S)

Description and Solubility

Description and Relative Solubility of USP and NF Articles (USP42-NF37 1S)

Description and Solubility - D

Description and Solubility - N

Description and Solubility - T

USP MONOGRAPHS

Amcinonide (USP42-NF37 1S)

Amcinonide Cream (USP42-NF37 1S)

Amcinonide Ointment (USP42-NF37 1S)

Amiloride Hydrochloride and Hydrochlorothiazide Tablets (USP42-NF37 1S)

Aminobenzoate Potassium for Oral Solution (USP42-NF37 1S)

Amiodarone Hydrochloride Injection (USP42-NF37 1S)

Amiodarone Hydrochloride Tablets [NEW] (USP42-NF37 1S)

Amoxicillin and Clavulanate Potassium for Oral Suspension (USP42-NF37 1S)

Amoxicillin and Clavulanate Potassium Tablets (USP42-NF37 1S)

Azithromycin Tablets (USP42-NF37 1S)

Belladonna Leaf (USP42-NF37 1S)

Belladonna Extract (USP42-NF37 1S)

Belladonna Extract Tablets (USP42-NF37 1S)

Belladonna Tincture (USP42-NF37 1S)

Benztropine Mesylate (USP42-NF37 1S)

Benztropine Mesylate Injection (USP42-NF37 1S)

Benztropine Mesylate Tablets (USP42-NF37 1S)

Budesonide Nasal Spray [NEW] (USP42-NF37 1S)

Cefazolin Ophthalmic Solution (USP42-NF37 1S)

Ciprofloxacin Ophthalmic Ointment (USP42-NF37 1S)

Ciprofloxacin Ophthalmic Solution (USP42-NF37 1S)

Clindamycin Phosphate (USP42-NF37 1S)

Clonazepam (USP42-NF37 1S)

Clonazepam Tablets (USP42-NF37 1S)

Cocaine and Tetracaine Hydrochlorides and Epinephrine Topical Solution (USP42-NF37 1S)

Corticotropin Injection (USP42-NF37 1S)

Corticotropin for Injection (USP42-NF37 1S)

Repository Corticotropin Injection (USP42-NF37 1S)

Cromolyn Sodium Oral Solution [NEW] (USP42-NF37 1S)

Dextrose (USP42-NF37 1S)

Diclofenac Potassium for Oral Solution [NEW] (USP42-NF37 1S)

Diclofenac Sodium Topical Gel [NEW] (USP42-NF37 1S)

Digitalis (USP42-NF37 1S)

Powdered Digitalis (USP42-NF37 1S)

Digitalis Capsules (USP42-NF37 1S)

Digitalis Tablets (USP42-NF37 1S)

PF 44(3): May.-Jun. 2018 2

Fluconazole Tablets (USP42-NF37 1S)

Fluvastatin Capsules (USP42-NF37 1S)

Gadoterate Meglumine Injection [NEW] (USP42-NF37 1S)

Galantamine Extended-Release Capsules (USP42-NF37 1S)

Galantamine Oral Solution (USP42-NF37 1S)

Galantamine Tablets (USP42-NF37 1S)

Galantamine Hydrobromide (USP42-NF37 1S)

Glucagon (USP42-NF37 1S)

Guanfacine Hydrochloride (USP42-NF37 1S)

Hydrocortisone Acetate (USP42-NF37 1S)

Hydrocortisone Acetate Cream (USP42-NF37 1S)

Hydroxychloroquine Sulfate Tablets (USP42-NF37 1S)

Milk of Magnesia (USP42-NF37 1S)

Magnesium Hydroxide Paste (USP42-NF37 1S)

Mesoridazine Besylate Oral Solution (USP42-NF37 1S)

Methotrexate for Injection (USP42-NF37 1S)

Methylcellulose Ophthalmic Solution (USP42-NF37 1S)

Methylcellulose Oral Solution (USP42-NF37 1S)

Methyldopa Oral Suspension (USP42-NF37 1S)

Methyldopa and Chlorothiazide Tablets (USP42-NF37 1S)

Methylene Blue Injection, Veterinary (USP42-NF37 1S)

Methylprednisolone (USP42-NF37 1S)

Methylprednisolone Acetate Cream (USP42-NF37 1S)

Methylprednisolone Hemisuccinate (USP42-NF37 1S)

Methysergide Maleate (USP42-NF37 1S)

Methysergide Maleate Tablets (USP42-NF37 1S)

Metyrapone Tablets (USP42-NF37 1S)

Mezlocillin Sodium (USP42-NF37 1S)

Mezlocillin for Injection (USP42-NF37 1S)

Miconazole Injection (USP42-NF37 1S)

Minocycline Hydrochloride Oral Suspension (USP42-NF37 1S)

Moricizine Hydrochloride Tablets (USP42-NF37 1S)

Morrhuate Sodium Injection (USP42-NF37 1S)

Nabumetone Tablets (USP42-NF37 1S)

Nafcillin Sodium Capsules (USP42-NF37 1S)

Nafcillin Sodium for Oral Solution (USP42-NF37 1S)

Nafcillin Sodium Tablets (USP42-NF37 1S)

Nalidixic Acid (USP42-NF37 1S)

Nalidixic Acid Oral Suspension (USP42-NF37 1S)

Nalidixic Acid Tablets (USP42-NF37 1S)

Naproxen Compounded Oral Suspension [NEW] (USP42-NF37 1S)

Netilmicin Sulfate (USP42-NF37 1S)

Netilmicin Sulfate Injection (USP42-NF37 1S)

Nilotinib [NEW] (USP42-NF37 1S)

Diluted Nitroglycerin (USP42-NF37 1S)

Nitroglycerin Injection (USP42-NF37 1S)

Nitroglycerin Ointment (USP42-NF37 1S)

Nitroglycerin Sublingual Tablets (USP42-NF37 1S)

PF 44(3): May.-Jun. 2018 3

Nitromersol (USP42-NF37 1S)

Norethindrone Acetate and Ethinyl Estradiol Tablets (USP42-NF37 1S)

Norfloxacin (USP42-NF37 1S)

Norfloxacin Ophthalmic Solution (USP42-NF37 1S)

Norfloxacin Tablets (USP42-NF37 1S)

Norgestrel Tablets (USP42-NF37 1S)

Omeprazole Oral Suspension (USP42-NF37 1S)

Omeprazole and Sodium Bicarbonate for Oral Suspension [NEW] (USP42-NF37 1S)

Oxacillin Sodium Capsules (USP42-NF37 1S)

Oxacillin Sodium for Oral Solution (USP42-NF37 1S)

Oxaliplatin Injection (USP42-NF37 1S)

Oxazepam Tablets (USP42-NF37 1S)

Pantoprazole Oral Suspension (USP42-NF37 1S)

Paroxetine Hydrochloride (USP42-NF37 1S)

Probucol (USP42-NF37 1S)

Probucol Tablets (USP42-NF37 1S)

Ranolazine [NEW] (USP42-NF37 1S)

Ranolazine Extended-Release Tablets [NEW] (USP42-NF37 1S)

Selamectin (USP42-NF37 1S)

Sitagliptin and Metformin Hydrochloride Tablets [NEW] (USP42-NF37 1S)

Sitagliptin and Metformin Hydrochloride Extended-Release Tablets [NEW] (USP42-NF37 1S)

Sorafenib Tosylate [NEW] (USP42-NF37 1S)

Stavudine for Oral Solution (USP42-NF37 1S)

Tetrabenazine [NEW] (USP42-NF37 1S)

Tetraxetan [NEW] (USP42-NF37 1S)

Triamcinolone Acetonide Lotion (USP42-NF37 1S)

Triamcinolone Acetonide Injectable Suspension (USP42-NF37 1S)

Xylometazoline Hydrochloride (USP42-NF37 1S)

Xylometazoline Hydrochloride Nasal Solution (USP42-NF37 1S)

DIETARY SUPPLEMENT MONOGRAPHS

Astaxanthin Esters (USP42-NF37 1S)

Creatine [NEW] (USP42-NF37 1S)

Cyanocobalamin Chewable Gels [NEW] (USP42-NF37 1S)

Omega-3 Free Fatty Acids [NEW] (USP42-NF37 1S)

STAGE 2 HARMONIZATION

Stage 2 Harmonization

NF MONOGRAPHS

Gelatin

STIMULI TO THE REVISION PROCESS

PF 44(3): May.-Jun. 2018 4

STIMULI TO THE REVISION PROCESS

The Complexity of Setting Compendial Specifications for Excipient Composition and Impurities

PF 44(3): May.-Jun. 2018 5

Table of Contents

PROPOSED IRA

Proposed Interim Revision Announcements

USP MONOGRAPHS

Insulin (1-JAN-2019)

Insulin Injection (1-JAN-2019)

Insulin Aspart Injection (1-JAN-2019)

Human Insulin Isophane Suspension and Human Insulin Injection (1-JAN-2019)

Isophane Insulin Suspension (1-JAN-2019)

Isophane Insulin Human Suspension (1-JAN-2019)

Insulin Lispro (1-JAN-2019)

Insulin Lispro Injection (1-JAN-2019)

Insulin Zinc Suspension (1-JAN-2019)

IN-PROCESS REVISION

In-Process Revision

GENERAL CHAPTERS

<203> HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHY PROCEDURE FOR IDENTIFICATION

OF ARTICLES OF BOTANICAL ORIGIN (USP42-NF37 2S)

<591> ZINC DETERMINATION (USP42-NF37 2S)

<607> PHARMACEUTICAL FOAMS-PRODUCT QUALITY TESTS [NEW] (USP42-NF37 2S)

<659> PACKAGING AND STORAGE REQUIREMENTS (USP42-NF37 2S)

<861> SUTURES-DIAMETER (USP42-NF37 2S)

<871> SUTURES-NEEDLE ATTACHMENT (USP42-NF37 2S)

<881> TENSILE STRENGTH (USP42-NF37 2S)

<1079> GOOD STORAGE AND DISTRIBUTION PRACTICES FOR DRUG PRODUCTS (USP42-NF37 2S)

<1085> GUIDELINES ON THE ENDOTOXINS TEST [NEW] (USP42-NF37 2S)

<1430> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA-GENERAL [NEW]

(USP42-NF37 2S)

<1430.1> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA-STATIC LIGHT

SCATTERING [NEW] (USP42-NF37 2S)

<1430.2> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA-LIGHT

DIFFRACTION MEASUREMENTS OF PARTICLE SIZE [NEW] (USP42-NF37 2S)

<1430.3> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA-DYNAMIC LIGHT

SCATTERING [NEW] (USP42-NF37 2S)

<1430.4> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA-

ELECTROPHORETIC LIGHT SCATTERING (DETERMINATION OF ZETA POTENTIAL) [NEW] (USP42-

NF37 2S)

<1430.5> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA-SMALL-ANGLE X-

RAY SCATTERING AND SMALL-ANGLE NEUTRON SCATTERING [NEW] (USP42-NF37 2S)

PF 44(4): Jul.-Aug. 2018 1

<1602> SPACERS AND VALVED HOLDING CHAMBERS USED WITH INHALATION AEROSOLS-

CHARACTERIZATION TESTS (USP42-NF37 2S)

<2091> WEIGHT VARIATION OF DIETARY SUPPLEMENTS (USP42-NF37 2S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Aqua Regia [NEW] (USP42-NF37 2S)

Triphenylphosphine Oxide [NEW] (USP42-NF37 2S)

Water, Ammonia-Free (USP42-NF37 2S)

Test Solutions

25% Tetrabutylammonium Hydroxide TS [NEW] (USP42-NF37 2S)

REFERENCE TABLES

Container Specifications

Container Specifications [NEW] (USP42-NF37 2S)

Description and Solubility

Description and Relative Solubility of USP and NF Articles (USP42-NF37 2S)

Description and Solubility - N

Description and Solubility - P

Description and Solubility - R

Description and Solubility - S

USP MONOGRAPHS

Acetaminophen Oral Solution (USP42-NF37 2S)

Albuterol Tablets (USP42-NF37 2S)

Aminobenzoate Potassium Tablets (USP42-NF37 2S)

Aminobenzoate Sodium (USP42-NF37 2S)

Amitriptyline Hydrochloride (USP42-NF37 2S)

Bimatoprost [NEW] (USP42-NF37 2S)

Bimatoprost Ophthalmic Solution [NEW] (USP42-NF37 2S)

Brimonidine Tartrate Ophthalmic Solution [NEW] (USP42-NF37 2S)

Bupropion Hydrochloride (USP42-NF37 2S)

Bupropion Hydrochloride Tablets (USP42-NF37 2S)

Bupropion Hydrochloride Extended-Release Tablets (USP42-NF37 2S)

Carbidopa and Levodopa Tablets (USP42-NF37 2S)

Clarithromycin Extended-Release Tablets (USP42-NF37 2S)

Clindamycin Phosphate Vaginal Cream (USP42-NF37 2S)

Clindamycin Phosphate Gel (USP42-NF37 2S)

Clonidine Hydrochloride (USP42-NF37 2S)

Clonidine Hydrochloride Injection [NEW] (USP42-NF37 2S)

Doxycycline Compounded Oral Suspension, Veterinary (USP42-NF37 2S)

Edetate Disodium Compounded Ophthalmic Solution [NEW] (USP42-NF37 2S)

PF 44(4): Jul.-Aug. 2018 2

Erythromycin (USP42-NF37 2S)

Erythromycin Ethylsuccinate (USP42-NF37 2S)

Erythromycin Stearate (USP42-NF37 2S)

Glycopyrrolate (USP42-NF37 2S)

Indomethacin Extended-Release Capsules (USP42-NF37 2S)

Insulin Human (USP42-NF37 2S)

Iodinated I 131 Albumin Aggregated Injection (USP42-NF37 2S)

Krypton Kr 81m (USP42-NF37 2S)

Levobunolol Hydrochloride Ophthalmic Solution (USP42-NF37 2S)

Lidocaine Hydrochloride Oral Topical Solution (USP42-NF37 2S)

Lidocaine Hydrochloride Topical Solution (USP42-NF37 2S)

Magaldrate Oral Suspension (USP42-NF37 2S)

Magaldrate Tablets (USP42-NF37 2S)

Magnesia Tablets (USP42-NF37 2S)

Mazindol (USP42-NF37 2S)

Mazindol Tablets (USP42-NF37 2S)

Menadiol Sodium Diphosphate (USP42-NF37 2S)

Menadiol Sodium Diphosphate Injection (USP42-NF37 2S)

Menadiol Sodium Diphosphate Tablets (USP42-NF37 2S)

Menadione Injection (USP42-NF37 2S)

Meropenem (USP42-NF37 2S)

Meropenem for Injection (USP42-NF37 2S)

Methylbenzethonium Chloride Ointment (USP42-NF37 2S)

Methylbenzethonium Chloride Topical Powder (USP42-NF37 2S)

Methylprednisolone Sodium Succinate for Injection (USP42-NF37 2S)

Monobenzone (USP42-NF37 2S)

Monobenzone Cream (USP42-NF37 2S)

Moricizine Hydrochloride (USP42-NF37 2S)

Nicardipine Hydrochloride Injection (USP42-NF37 2S)

Nitazoxanide [NEW] (USP42-NF37 2S)

Omeprazole and Sodium Bicarbonate Capsules [NEW] (USP42-NF37 2S)

Oxprenolol Hydrochloride Tablets (USP42-NF37 2S)

Oxycodone Hydrochloride Oral Solution (USP42-NF37 2S)

Piperacillin Sodium (USP42-NF37 2S)

Pregabalin (USP42-NF37 2S)

Pseudoephedrine Hydrochloride (USP42-NF37 2S)

Pseudoephedrine Hydrochloride Extended-Release Tablets (USP42-NF37 2S)

Quinapril Tablets (USP42-NF37 2S)

Rifabutin (USP42-NF37 2S)

Rifabutin Capsules (USP42-NF37 2S)

Ropivacaine Hydrochloride (USP42-NF37 2S)

Rufinamide Tablets (USP42-NF37 2S)

Sodium Fluoride Gel (USP42-NF37 2S)

Absorbable Surgical Suture (USP42-NF37 2S)

Nonabsorbable Surgical Suture (USP42-NF37 2S)

Tetracycline Hydrochloride Capsules (USP42-NF37 2S)

Tizanidine Capsules [NEW] (USP42-NF37 2S)

Triamterene and Hydrochlorothiazide Tablets (USP42-NF37 2S)

PF 44(4): Jul.-Aug. 2018 3

Trifluridine (USP42-NF37 2S)

Valproate Sodium Injection (USP42-NF37 2S)

DIETARY SUPPLEMENT MONOGRAPHS

Ascorbic Acid Chewable Gels (USP42-NF37 2S)

Cholecalciferol Chewable Gels (USP42-NF37 2S)

Menaquinone-7 (USP42-NF37 2S)

Menaquinone-7 Preparation (USP42-NF37 2S)

Pyrroloquinoline Quinone Disodium [NEW] (USP42-NF37 2S)

EXCIPIENTS

Excipients (USP and NF), Listed By Category (USP42-NF37 2S)

Briefing

Introduction

Emollient

Solvent

Vehicle

NF MONOGRAPHS

Aluminum Monostearate (USP42-NF37 2S)

Hexylene Glycol (USP42-NF37 2S)

Polypropylene Glycol 11 Stearyl Ether [NEW] (USP42-NF37 2S)

STAGE 4 HARMONIZATION

Stage 2 Harmonization

STIMULI TO THE REVISION PROCESS

Modernization of Color Measurement Methods in the USP-NF

The Application of Abbreviated Impactor Measurement and Efficient Data Analysis in the

Lifecycle of an Orally-Inhaled Product: A Roadmap

The Use of Mean Kinetic Temperature to Aid Evaluation of Temperature Excursions: Proper and

Improper Application

PF 44(4): Jul.-Aug. 2018 4

Table of Contents

PROPOSED IRA

Proposed Interim Revision Announcements

NF MONOGRAPHS

Medium-Chain Triglycerides (1-Mar-2019)

IN-PROCESS REVISION

In-Process Revision

GENERAL CHAPTERS

<3> Topical and Transdermal Drug Products - Product Quality Tests (USP42-NF37 2S)

<60> Microbiological Examination of Nonsterile Products - Tests for Burkholderia Cepacia

Complex [NEW] (USP42-NF37 2S)

<81> Antibiotics - Microbial Assays (USP42-NF37 2S)

<601> Inhalation and Nasal Drug Products - Aerosols, Sprays, and Powders - Performance

Quality Tests (USP42-NF37 2S)

<771> Opthalmic Products - Quality Tests (USP42-NF37 2S)

<785> Osmolality and Osmolarity (USP42-NF37 2S)

<797> Pharmaceutical Compounding - Sterile Preparations (USP42-NF37 2S)

TABLE OF CONTENTS

INTRODUCTION

ORGANIZATION OF THIS CHAPTER

RESPONSIBILITY OF COMPOUNDING PERSONNEL

CSP MICROBIAL CONTAMINATION RISK LEVELS

PERSONNEL TRAINING AND EVALUATION IN ASEPTIC MANIPULATION SKILLS

IMMEDIATE-USE CSPs

SINGLE-DOSE AND MULTIPLE-DOSE CONTAINERS

HAZARDOUS DRUGS AS CSPs

RADIOPHARMACEUTICALS AS CSPs

ALLERGEN EXTRACTS AS CSPs

VERIFICATION OF COMPOUNDING ACCURACY AND STERILITY

ENVIRONMENTAL QUALITY AND CONTROL

SUGGESTED STANDARD OPERATING PROCEDURES (SOPs)

ELEMENTS OF QUALITY CONTROL

VERIFICATION OF AUTOMATED COMPOUNDING DEVICES (ACDs) FOR PARENTERAL NUTRITION

COMPOUNDING

FINISHED PREPARATION RELEASE CHECKS AND TESTS

STORAGE AND BEYOND-USE DATING

MAINTAINING STERILITY, PURITY, AND STABILITY OF DISPENSED AND DISTRIBUTED CSPs

PATIENT OR CAREGIVER TRAINING

PATIENT MONITORING AND ADVERSE EVENTS REPORTING

PF 44(5): Sep.-Oct. 2018 1

QUALITY ASSURANCE (QA) PROGRAM

ABBREVIATIONS AND ACRONYMS

GLOSSARY

APPENDICES

1. INTRODUCTION AND SCOPE

2.PERSONNEL QUALIFICATIONS--TRAINING, EVALUATION, AND REQUALIFICATION

3.PERSONAL HYGIENE AND GARBING

4.FACILITIES AND ENGINEERING CONTROLS

5. MICROBIOLOGICAL AIR AND SURFACE MONITORING

6. CLEANING AND DISINFECTING COMPOUNDING AREAS

7. EQUIPMENT, SUPPLIES, AND COMPONENTS

8. STERILIZATION AND DEPYROGENATION

9. SOPs AND MASTER FORMULATION AND COMPOUNDING RECORDS

10. RELEASE TESTING

11. LABELING

12. ESTABLISHING BEYOND-USE DATES

13. USE OF CONVENTIONALLY MANUFACTURED PRODUCTS

14. USE OF CSPs AS COMPONENTS

15. QUALITY ASSURANCE AND QUALITY CONTROL

16. CSP STORAGE, HANDLING, PACKAGING, SHIPPING, AND TRANSPORT

17. DOCUMENTATION

18. COMPOUNDING ALLERGENIC EXTRACTS

GLOSSARY

APPENDICES

Endnotes

<825> Radiopharmaceuticals - Preparation, Compounding, Dispensing, and Repackaging [NEW]

(USP42-NF37 2S)

<856> Near-Infrared Spectroscopy [NEW] (USP42-NF37 2S)

<857> Ultraviolet-Visible Spectroscopy (USP42-NF37 2S)

<1010> Analytical Data - Interpretation and Treatment (USP42-NF37 2S)

<1071> Rapid Sterility Testing of Short-Life Products - A Risk Based Approach [NEW] (USP42-

NF37 2S)

<1103> Immunological Test Methods - Enzyme-Linked Immunosorbent Assay (ELISA) (USP42-

NF37 2S)

<1119> Near-Infrared Spectroscopy (USP42-NF37 2S)

<1136> Packaging and Repackaging - Single-Unit Containers (USP42-NF37 2S)

<1177> Good Packaging Practices (USP42-NF37 2S)

<1227> Validation of Microbial Recovery From Pharmacopeial Articles (USP42-NF37 2S)

<1229.16> Prion Sterilization [NEW] (USP42-NF37 2S)

<1236> Solubility Measurements [NEW] (USP42-NF37 2S)

<1711> Oral Solid Dosage Forms - Dissolution Testing [NEW] (USP42-NF37 2S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Aluminum Chloride Hexahydrate [NEW] (USP42-NF37 2S)

PF 44(5): Sep.-Oct. 2018 2

Indicators

Eriochrome Black T (USP42-NF37 2S)

REFERENCE TABLES

Container Specifications

Container Specifications [NEW] (USP42-NF37 2S)

Description and Solubility

Description and Relative Solubility of USP and NF Articles (USP42-NF37 2S)

Description and Solubility - G

USP MONOGRAPHS

Abacavir, Lamivudine and Zidovudine Tablets [NEW] (USP42-NF37 2S)

Arginine (USP42-NF37 2S)

Arginine Hydrochloride (USP42-NF37 2S)

Arginine Hydrochloride Compounded Oral Solution [NEW] (USP42-NF37 2S)

Astemizole (USP42-NF37 2S)

Astemizole Tablets (USP42-NF37 2S)

Atovaquone and Proguanil Hydrochloride Tablets [NEW] (USP42-NF37 2S)

Atropine Sulfate Tablets (USP42-NF37 2S)

Azatadine Maleate (USP42-NF37 2S)

Azithromycin for Oral Suspension (USP42-NF37 2S)

Baclofen Injection [NEW] (USP42-NF37 2S)

Bisoprolol Fumarate (USP42-NF37 2S)

Bisoprolol Fumarate Tablets (USP42-NF37 2S)

Cetylpyridinium Chloride (USP42-NF37 2S)

Chlorambucil Compounded Oral Suspension [NEW] (USP42-NF37 2S)

Chloramphenicol Compounded Oral Suspension, Veterinary [NEW] (USP42-NF37 2S)

Chlordiazepoxide (USP42-NF37 2S)

Chlordiazepoxide Hydrochloride (USP42-NF37 2S)

Clonidine Hydrochloride Compounded Oral Suspension [NEW] (USP42-NF37 2S)

Clozapine (USP42-NF37 2S)

Clozapine Tablets (USP42-NF37 2S)

Dehydrocholic Acid Tablets (USP42-NF37 2S)

Demeclocycline (USP42-NF37 2S)

Demeclocycline Oral Suspension (USP42-NF37 2S)

Demeclocycline Hydrochloride Capsules (USP42-NF37 2S)

Deslanoside (USP42-NF37 2S)

Desmopressin Acetate (USP42-NF37 2S)

Dexamethasone Acetate Injectable Suspension (USP42-NF37 2S)

Dexamethasone Sodium Phosphate Cream (USP42-NF37 2S)

Dexamethasone Sodium Phosphate Ophthalmic Ointment (USP42-NF37 2S)

Dextroamphetamine Sulfate Capsules (USP42-NF37 2S)

Diatrizoate Sodium (USP42-NF37 2S)

Diazepam Capsules (USP42-NF37 2S)

Diazepam Extended-Release Capsules (USP42-NF37 2S)

PF 44(5): Sep.-Oct. 2018 3

Dichloralphenazone (USP42-NF37 2S)

Dicloxacillin Sodium for Oral Suspension (USP42-NF37 2S)

Diethylstilbestrol Injection (USP42-NF37 2S)

Diethylstilbestrol Tablets (USP42-NF37 2S)

Diphenhydramine Hydrochloride Oral Powder [NEW] (USP42-NF37 2S)

Doxazosin Tablets (USP42-NF37 2S)

Enalapril Maleate (USP42-NF37 2S)

Epinephrine Bitartrate (USP42-NF37 2S)

Ezetimibe (USP42-NF37 2S)

Felodipine (USP42-NF37 2S)

Fenoldopam Mesylate Injection (USP42-NF37 2S)

Hard Gelatin Capsule Shell (USP42-NF37 2S)

Hydrochlorothiazide Compounded Oral Suspension [NEW] (USP42-NF37 2S)

Hydrocortisone (USP42-NF37 2S)

Hard Hypromellose Capsule Shell (USP42-NF37 2S)

Levodopa Capsules (USP42-NF37 2S)

Levodopa Tablets (USP42-NF37 2S)

Levofloxacin Tablets (USP42-NF37 2S)

Lidocaine, Racepinephrine and Tetracaine Hydrochlorides Compounded Topical Gel [NEW]

(USP42-NF37 2S)

Loracarbef (USP42-NF37 2S)

Magnesium Citrate (USP42-NF37 2S)

Memantine Hydrochloride Oral Solution [NEW] (USP42-NF37 2S)

Methacholine Chloride (USP42-NF37 2S)

Oxtriphylline Oral Solution (USP42-NF37 2S)

Oxtriphylline Tablets (USP42-NF37 2S)

Oxycodone Hydrochloride Extended-Release Tablets (USP42-NF37 2S)

Oxytetracycline and Nystatin Capsules (USP42-NF37 2S)

Oxytetracycline and Nystatin for Oral Suspension (USP42-NF37 2S)

Oxytetracycline Calcium (USP42-NF37 2S)

Oxytetracycline Calcium Oral Suspension (USP42-NF37 2S)

Phensuximide (USP42-NF37 2S)

Phensuximide Capsules (USP42-NF37 2S)

Phenytoin Compounded Topical Gel [NEW] (USP42-NF37 2S)

Physostigmine Salicylate Ophthalmic Solution (USP42-NF37 2S)

Piroxicam (USP42-NF37 2S)

Potassium Perchlorate Capsules (USP42-NF37 2S)

Pregabalin Capsules [NEW] (USP44-NF39 1S)

Propoxycaine Hydrochloride (USP42-NF37 2S)

Propyliodone Injectable Oil Suspension (USP42-NF37 2S)

Quinine Sulfate Capsules (USP42-NF37 2S)

Repaglinide and Metformin Hydrochloride Tablets [NEW] (USP42-NF37 2S)

Rifampin (USP42-NF37 2S)

Rifampin Capsules (USP42-NF37 2S)

Rifampin for Injection (USP42-NF37 2S)

Sodium Fluoride Tablets (USP42-NF37 2S)

Thioridazine Oral Suspension (USP42-NF37 2S)

Timolol Maleate (USP42-NF37 2S)

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Torsemide Compounded Oral Suspension [NEW] (USP42-NF37 2S)

Tranexamic Acid (USP42-NF37 2S)

Triamcinolone Acetonide Cream (USP42-NF37 2S)

Triamcinolone Acetonide Dental Paste (USP42-NF37 2S)

Vancomycin (USP42-NF37 2S)

DIETARY SUPPLEMENT MONOGRAPHS

Bael Tree Fruit [NEW] (USP42-NF37 2S)

Bael Tree Fruit Dry Extract [NEW] (USP42-NF37 2S)

Bael Tree Fruit Powder [NEW] (USP42-NF37 2S)

Cobamamide (USP42-NF37 2S)

Coptis Species Rhizome [NEW] (USP42-NF37 2S)

Coptis Species Rhizome Dry Extract [NEW] (USP42-NF37 2S)

Coptis Species Rhizome Powder [NEW] (USP42-NF37 2S)

Cystine (USP42-NF37 2S)

Indian Barberry Stem [NEW] (USP42-NF37 2S)

Indian Barberry Stem Dry Extract [NEW] (USP42-NF37 2S)

Indian Barberry Stem Powder [NEW] (USP42-NF37 2S)

Terminalia Chebula Fruit [NEW] (USP42-NF37 2S)

Terminalia Chebula Fruit Dry Extract [NEW] (USP42-NF37 2S)

Terminalia Chebula Fruit Powder [NEW] (USP42-NF37 2S)

EXCIPIENTS

Excipients (USP and NF), Listed By Category (USP42-NF37 2S)

Briefing

Introduction

Emulsifying Agent

Lubricant

NF MONOGRAPHS

Purified Bentonite (USP42-NF37 2S)

Galactose (USP42-NF37 2S)

Glyceryl Mono and Dicaprylate [NEW] (USP42-NF37 2S)

Glyceryl Mono and Dicaprylocaprate [NEW] (USP42-NF37 2S)

Glyceryl Monocaprylate (USP42-NF37 2S)

Glyceryl Monocaprylocaprate (USP42-NF37 2S)

STAGE 2 HARMONIZATION

Stage 2 Harmonization

STIMULI TO THE REVISION PROCESS

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Acceptance Sampling Strategies Applied to USP <790> Visible Particulates In Injections

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Table of Contents

PROPOSED IRA

Proposed Interim Revision Announcements

IN-PROCESS REVISION

In-Process Revision

GENERAL CHAPTERS

<432> DETERMINATION OF ZETA POTENTIAL BY ELECTROPHORETIC LIGHT SCATTERING [NEW]

(USP43-NF38)

<784> DROPPING POINT [NEW] (USP43-NF38)

<922> WATER ACTIVITY [NEW] (USP43-NF38)

<1042> CELL BANKING [NEW] (USP43-NF38)

<1043> ANCILLARY MATERIALS FOR CELL, GENE, AND TISSUE-ENGINEERED PRODUCTS (USP43-

NF38)

<1046> CELLULAR AND TISSUE-BASED PRODUCTS (USP43-NF38)

<1047> GENE THERAPY PRODUCTS (USP43-NF38)

<1092> THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION (USP43-NF38)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Glyceryl Monostearate [NEW] (USP43-NF38)

Lecithin [NEW] (USP43-NF38)

Lysolecithin [NEW] (USP43-NF38)

Manganese Chloride Tetrahydrate [NEW] (USP43-NF38)

Manganese Sulfate [NEW] (USP43-NF38)

Methyl Red (USP43-NF38)

Polypeptone [NEW] (USP43-NF38)

Polysorbate 20 [NEW] (USP43-NF38)

Sodium Butyrate [NEW] (USP43-NF38)

Sodium Oleate [NEW] (USP43-NF38)

Sodium Propionate [NEW] (USP43-NF38)

Sodium Taurocholate [NEW] (USP43-NF38)

Sodium Taurodeoxycholate [NEW] (USP43-NF38)

Indicators

Methyl Red (USP43-NF38)

Xylenol Orange (USP43-NF38)

Test Solutions

18 N Phosphoric Acid TS [NEW] (USP43-NF38)

50% Sodium Hydroxide TS [NEW] (USP43-NF38)

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Xylenol Orange TS (USP43-NF38)

REFERENCE TABLES

Container Specifications

Container Specifications [NEW] (USP43-NF38)

Description and Solubility

Description and Relative Solubility of USP and NF Articles (USP43-NF38)

Description and Solubility - M

Description and Solubility - R

Description and Solubility - T

USP MONOGRAPHS

Amiloride Hydrochloride (USP43-NF38)

Apomorphine Hydrochloride Tablets (USP43-NF38)

Aurothioglucose (USP43-NF38)

Aurothioglucose Injectable Suspension (USP43-NF38)

Azatadine Maleate Tablets (USP43-NF38)

Carboxymethylcellulose Sodium Compounded Solution, Veterinary [NEW] (USP43-NF38)

Cetirizine Hydrochloride Capsules [NEW] (USP43-NF38)

Cholecalciferol (USP43-NF38)

Clonidine Hydrochloride Extended-Release Tablets [NEW] (USP43-NF38)

Codeine Phosphate (USP43-NF38)

Cyclophosphamide Capsules [NEW] (USP43-NF38)

Demeclocycline Hydrochloride (USP43-NF38)

Demeclocycline Hydrochloride Tablets (USP43-NF38)

Deslanoside Injection (USP43-NF38)

Diazoxide Capsules (USP43-NF38)

Diazoxide Injection (USP43-NF38)

Diethylcarbamazine Citrate (USP43-NF38)

Diflunisal Tablets (USP43-NF38)

Doxepin Hydrochloride Capsules (USP43-NF38)

Dronabinol Capsules (USP43-NF38)

Epinephrine Injection (USP43-NF38)

Ergocalciferol (USP43-NF38)

Estradiol and Norethindrone Acetate Tablets (USP43-NF38)

Exemestane Tablets [NEW] (USP43-NF38)

Fexofenadine Hydrochloride Orally Disintegrating Tablets [NEW] (USP43-NF38)

Fluphenazine Hydrochloride (USP43-NF38)

Fluphenazine Hydrochloride Elixir (USP43-NF38)

Fluphenazine Hydrochloride Injection (USP43-NF38)

Fluphenazine Hydrochloride Oral Solution (USP43-NF38)

Fluphenazine Hydrochloride Tablets (USP43-NF38)

Hydrocortisone Cream (USP43-NF38)

Hydrocortisone Gel (USP43-NF38)

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Hydrocortisone Ointment (USP43-NF38)

Hydrocortisone Tablets (USP43-NF38)

Loratadine Capsules [NEW] (USP43-NF38)

Memantine Hydrochloride Extended-Release Capsules [NEW] (USP43-NF38)

Metformin Hydrochloride (USP43-NF38)

Nebivolol Hydrochloride [NEW] (USP43-NF38)

Neomycin Sulfate (USP43-NF38)

Nicardipine Hydrochloride (USP43-NF38)

Nicardipine Hydrochloride in Dextrose Injection [NEW] (USP43-NF38)

Nicardipine Hydrochloride in Sodium Chloride Injection [NEW] (USP43-NF38)

Norgestimate and Ethinyl Estradiol Tablets (USP43-NF38)

Oxprenolol Hydrochloride Extended-Release Tablets (USP43-NF38)

Oxycodone and Acetaminophen Capsules (USP43-NF38)

Oxymetholone (USP43-NF38)

Oxymetholone Tablets (USP43-NF38)

Paclitaxel Injection (USP43-NF38)

Parachlorophenol (USP43-NF38)

Piperazine Citrate Tablets (USP43-NF38)

Potassium Perchlorate (USP43-NF38)

Prednisolone Cream (USP43-NF38)

Prednisolone Acetate (USP43-NF38)

Prednisolone Acetate Ophthalmic Suspension (USP43-NF38)

Primidone Oral Suspension (USP43-NF38)

Procaine and Tetracaine Hydrochlorides and Levonordefrin Injection (USP43-NF38)

Promazine Hydrochloride Syrup (USP43-NF38)

Propoxycaine and Procaine Hydrochlorides and Levonordefrin Injection (USP43-NF38)

Propoxycaine and Procaine Hydrochlorides and Norepinephrine Bitartrate Injection (USP43-NF38)

Propyliodone (USP43-NF38)

Pyrvinium Pamoate (USP43-NF38)

Pyrvinium Pamoate Oral Suspension (USP43-NF38)

Pyrvinium Pamoate Tablets (USP43-NF38)

Regorafenib [NEW] (USP43-NF38)

Risedronate Sodium (USP43-NF38)

Risperidone Oral Solution (USP43-NF38)

Ritodrine Hydrochloride (USP43-NF38)

Ritodrine Hydrochloride Injection (USP43-NF38)

Ritodrine Hydrochloride Tablets (USP43-NF38)

Scopolamine Hydrobromide Injection (USP43-NF38)

Scopolamine Hydrobromide Ophthalmic Solution (USP43-NF38)

Scopolamine Hydrobromide Tablets (USP43-NF38)

Secobarbital (USP43-NF38)

Selenium Sulfide (USP43-NF38)

Sodium Acetate Solution (USP43-NF38)

Sodium Benzoate Compounded Oral Solution [NEW] (USP43-NF38)

Sodium Butyrate (USP43-NF38)

Thioridazine (USP43-NF38)

Thioridazine Hydrochloride Oral Solution (USP43-NF38)

Ticagrelor [NEW] (USP43-NF38)

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Venlafaxine Extended-Release Tablets [NEW] (USP43-NF38)

Vitamin A Tablets (USP43-NF38)

DIETARY SUPPLEMENT MONOGRAPHS

Calcium with Vitamin D Tablets (USP43-NF38)

Calcium and Vitamin D with Minerals Tablets (USP43-NF38)

Japanese Sophora Flower [NEW] (USP43-NF38)

Japanese Sophora Flower Dry Extract [NEW] (USP43-NF38)

Japanese Sophora Flower Powder [NEW] (USP43-NF38)

Oil-Soluble Vitamins Tablets (USP43-NF38)

Oil-Soluble Vitamins with Minerals Tablets (USP43-NF38)

Oil- and Water-Soluble Vitamins Tablets (USP43-NF38)

Oil- and Water-Soluble Vitamins with Minerals Tablets (USP43-NF38)

Water-Soluble Vitamins Tablets (USP43-NF38)

Water-Soluble Vitamins with Minerals Tablets (USP43-NF38)

NF MONOGRAPHS

Alginic Acid (USP43-NF38)

Lauroyl Polyoxylglycerides (USP43-NF38)

Potassium Alginate (USP43-NF38)

Sodium Alginate (USP43-NF38)

Medium-Chain Triglycerides (USP43-NF38)

STAGE 2 HARMONIZATION

Stage 2 Harmonization

STIMULI TO THE REVISION PROCESS

Guidelines For Assessing and Controlling the Physical Stability of Pharmaceutical Raw Materials,

Intermediates, and Dosage Forms

In Vitro Release Test Methods for Drug Formulations for Parenteral Applications

USP (Pharmacopeial) Perspective for Pharmaceutical Continuous Manufacturing

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