Japanese Pharmacopoeial Forum
Vol. 25

No. 2June 2016

Contents

Revision Drafts
Revision Drafts on Dissolution for First Supplement toJP 17
１. Official Monographs(1) Addition
Adenosine Triphosphate Disodium Delayedrelease Granules ··································· 326
Cloperastine Fendizoate Tablets····················· 326
Irbesartan and Amlodipine Besilate Tablets ······· 327
Itopride Hydrochloride Tablets ······················ 328
Montelukast Sodium Granules ······················ 329
Revision Drafts for First Supplement to JP 17
１. General Rules for Preparations ·························· 330
２. General Tests, Processes and Apparatus(1) Addition
3.06 Laser Diffraction Measurement of Particle
Size ················································· 331(2) Revision
9.41 Reagents, Test solution ······················· 335
３. Official Monographs(1) Addition
Azosemide·············································· 335
Azosemide Tablets ···································· 336
Glucose Hydrate ······································· 338
Purified Glucose ······································· 339
Irbesartan and Amlodipine Besilate Tablets ······· 341
Isophane Insulin Human (Genetical Recombination)
Injectable Aqueous Suspension ················· 344
Biphasic Isophane Insulin Human (GeneticalRecombination) Injectable AqueousSuspension ·········································· 346
Methotrexate Tablets·································· 348
Montelukast Sodium Granules ······················ 349
Voriconazole for Injection ··························· 351(2) Revision
Ampicillin Hydrate ···································· 353
Benzylpenicillin Potassium ·························· 353
Chloramphenicol Sodium Succinate ················ 354
Cloxacillin Sodium Hydrate ························· 354
Doxycycline Hydrochloride Hydrate ··············· 355
Glucose Injection ······································ 356
Low Substituted Hydroxypropylcellulose·········· 356

Hypromellose ········································· 357
Anhydrous Lactose ··································· 359
Sodium Lauryl Sulfate ······························· 359
Methylcellulose ······································· 361
Sulbactam Sodium···································· 362
Verapamil Hydrochloride ··························· 363
Verapamil Hydrochloride Tablets ·················· 363
４. Official Monographs－Crude Drugs(1) Revision
Cyperus Rhizome ····································· 364
Powdered Cyperus Rhizome ························ 365
Glycyrrhiza Extract··································· 365
Crude Glycyrrhiza Extract··························· 365
Oriental Bezoar ······································· 366
Saposhnikovia Root and Rhizome ················· 367
５. Infrared Reference Spectra
Azosemide ············································· 367
Low Substituted Hydroxypropylcellulose ········· 368
６. Ultraviolet-visible Reference Spectra
Azosemide ············································· 368
Doxycycline Hydrochloride Hydrate ·············· 368
７. General Information(1) Addition
Moisture Permeability Test for Blister Packagingof Solid Preparations ···························· 369(2) Deletion
Laser Diffraction Measurement of Particle Size·· 370
Additional Revision of the Revision Drafts for First
Supplement to JP 17
１. Official Monographs(1) Addition
Amoxicillin Hydrate ································· 371

Pharmacopoeial Harmonization
１．Official Inquiry Stage Draft(1)Monographs1)Addition①Copovidone ··········································· 2772)Revision①Calcium Disodium Edetate·························· 284

Useful Information
PMRJ Reference Standards Ordering Information
for Foreign Users ··········································· 372

Publishing Schedule (Vol.25, No.3): September 2016