Japanese Pharmacopoeial Forum
Vol. 24

No. 2

June 2015

Contents

Revision Drafts
Revision Drafts for First Supplement to JP 17
１. Official Monographs(1) Addition
Chlorpromazine Hydrochloride ･ Phenobarbital ･Promethazine Hydrochloride Tablets ············· 311
Magnesium Aluminosilicate ··························· 313
Magnesium Aluminometasilicate ····················· 314
Mesalazine Sustained Release Tablets ··············· 316
Rilmazafone Hydrochloride Tablets ················· 316
Roxithromycin Tablets ································· 317
Drafts for JP 17
１. General Notices ············································· 320
２. General Rules for Preparations ··························· 320
３. General Tests, Processes and Apparatus(1) Addition
2.64 Glycosylation analysis of glycoprotein ······ 322
6.13 Methods of Adhesion Testing················· 324
４. Official Monographs(1) Revision
Alprostadil Injection ···································· 327
Amphotericin B for Injection·························· 327
Amphotericin B Tablets ································ 327
Anhydrous Ethanol ····································· 327
Arbekacin Sulfate ······································· 328
Arsenical Paste ·········································· 328
Benzylpenicillin Benzathine Hydrate ················ 328
Benzylpenicillin Potassium ···························· 329
Betahistine Mesilate ···································· 330
Bifonazole ················································ 330
Buformin Hydrochloride Enteric-coated Tablets ··· 330
Bunazosin Hydrochloride ······························ 330
Calcium Paraaminosalicylate Hydrate ··············· 331
Candesartan Cilexetil ··································· 331
Ceftriaxone Sodium Hydrate ·························· 331
Celmoleukin (Genetical Recombination)············ 331
Clomifene Citrate ······································· 338
Codeine Phosphate Hydrate ··························· 338
Colistin Sodium Methanesulfonate ··················· 339

Colistin Sulfate ··········································· 339
Compound Oxycodone and Atropine Injection ····· 339
Compound Oxycodone Injection ······················ 340
Cyanocobalamin ········································· 340
Cyproheptadine Hydrochloride Hydrate ············· 341
Dantrolene Sodium Hydrate ··························· 341
Diarsenic Trioxide ······································· 341
Domperidone ············································· 341
Doxapram Hydrochloride Hydrate ···················· 341
Doxycycline Hydrochloride Hydrate ················· 342
Droperidol ················································ 342
Ebastine ··················································· 342
Emedastine Fumarate ··································· 342
Enoxacin Hydrate ········································ 342
Epoetin Beta (Genetical Recombination) ············ 343
Erythromycin Enteric-Coated Tablets ················ 343
Estradiol Benzoate Injection (Aqueous Suspension)··························································· 343
Estriol Injection (Aqueous Suspension) ·············· 343
Ethanol ···················································· 343
Faropenem Sodium Hydrate ··························· 344
Felbinac ··················································· 344
Fenbufen ·················································· 345
Fluorescein Sodium ····································· 345
Flurbiprofen ·············································· 345
Gonadorelin Acetate····································· 345
Heparin Calcium ········································· 345
Heparin Sodium ·········································· 348
Hydroxocobalamin Acetate ···························· 350
Hydroxypropylcellulose ································ 350
Hydroxyzine Hydrochloride ··························· 353
Hypromellose············································· 353
Idarubicin Hydrochloride ······························· 353
Imipenem and Cilastatin Sodium for Injection ······ 354
Insulin Glargine (Genetical Recombination) ········ 354
Insulin Glargine Injection(Genetical Recombination)··························································· 356
Insulin Human (Genetical Recombination) ·········· 356
Insulin Human (Genetical Recombination) Injection··························································· 357

Levofloxacin Hydrate ··································· 358
Mecobalamin ············································· 358
Methylcellulose ·········································· 358
Methyldopa Hydrate ···································· 359
Metildigoxin ·············································· 359
Nafamostat Mesilate ···································· 359
Nifedipine················································· 359
Nifedipine Enteric Fine Granules ····················· 360
Omeprazole ··············································· 360
Omeprazole Enteric-coated Tablets ·················· 360
Oxycodone Hydrochloride Hydrate ·················· 360
Paroxetine Hydrochloride Hydrate ··················· 361
Perphenazine Maleate··································· 361
Pilsicainide Hydrochloride Hydrate ·················· 361
Pimozide ·················································· 362
Polymixin B Sulfate ····································· 362
Polysorbate 80 ··········································· 362
Potassium Guaiacolsulfonate ·························· 363
Povidone ·················································· 363
Pranlukast Hydrate ······································ 367
Procaterol Hydrochloride Hydrate ···················· 367
Prochlorperazine Maleate ······························ 368
Purified Gelatin ·········································· 368
Pyridoxine Hydrochloride ······························ 371
Rabeprazole Sodium ···································· 371
Risperidone ··············································· 371
Saccharin·················································· 371
Sodium Risedronate Hydrate ·························· 371
Teceleukin (Genetical Recombination) ·············· 372
Teceleukin for Injection (Genetical Recombination)·························································· 379
Ticlopidine Hydrochloride ····························· 379
Tipepidine Hibenzate ··································· 379
Wheat Starch ············································· 380
５. Official Monographs－Crude Drugs(1) Revision
Alisma Tuber ············································· 380
Amomum Seed··········································· 381
Powdered Amomum Seed ······························ 382
Corydalis Tuber ·········································· 382
Powdered Corydalis Tuber ····························· 383
Forsythia Fruit ··········································· 383Ipecac ······················································ 384
Ipecac Syrup ·············································· 384
Powdered Ipecac ········································· 385
Japanese Angelica Root ································ 385
Powdered Japanese Angelica Root ··················· 385
Japanese Valerian ······································· 385
Powdered Japanese Valerian··························· 385
Mentha Herb ············································· 386
Plantago Seed ············································ 386
Saussurea Root ··········································· 386

Sweet Hydrangea Leaf ································· 386
Revision of coefficient term in Calculating Formula for
Assay of Crude Drugs ········································· 387
６. General Information(1) Addition
Basic Concepts for Quality Assurance of Drug
Substances and Drug Products ····················· 388
Basic requirements and terms for the packaging ofpharmaceutical products ···························· 389
Monosaccharide analysis and oligosaccharide
analysis/oligosaccharide profiling ················· 394
Parametric Release of Terminally Sterilized
Pharmaceutical Products ···························· 400Rapid Microbial Methods ······························ 405
Reference Standards and Reference Materials
Specified in the Japanese Pharmacopoeia ········ 407
Thin-layer Chromatography for Crude Drugs andCrude Drug Products ································ 410(2) Revision
Preservatives-Effectiveness Tests ···················· 413
On the Scientific Names of Crude Drugs listed inthe JP ··················································· 418
Additional Revision of the Revision Drafts for JP 17
１. General Tests, Processes and Apparatus(1) Revision
5.02 Microbial Limit Test for Crude Drags andRelated Preparations ································· 431
２. Official Monographs(1) Addition
Ampicillin Sodium-Sulbactam Sodium for Injection443
Cefoperazone Sodium-Sulbactam Sodium forInjection ··············································· 443
Ciprofloxacin ············································ 444
Ciprofloxacin Hydrochloride Hydrate ··············· 445
Montelukast Sodium ···································· 446
Montelukast Sodium Tablets ·························· 449
Montelukast Sodium Chewable Tablets ············· 451
Ozagrel Sodium Injection ······························ 453
Panipenem and Betamipron for Injection ··········· 453
Sultamicillin Tosilate Tablets ························· 455
Valaciclovir Hydrochloride ···························· 455

Useful Information
PMRJ Reference Standards Ordering Information forForeign Users ················································· 457

Publishing Schedule (Vol.24, No.3): September 2015