Japanese Pharmacopoeial Forum
Vol. 25

No. 3

September 2016

Contents

Revision Drafts
Revision Drafts on Dissolution for First Supplement toJP 17
１. Official Monographs(1) Addition
Clomipramine Hydrochloride Tablets ·············· 531
Clotiazepam Tablets ·································· 531
Irbesartan Tablets······································ 532
Minocycline Hydrochloride Granules ·············· 532
Zonisamide Tablets ··································· 533(2) Revision
Verapamil Hydrochloride Tablets ··················· 533
Revision Drafts for First Supplement to JP 17
１. General Rules for Preparations ·························· 534
２. General Tests, Processes and Apparatus(1) Revision
2.24 Ultraviolet-visible Spectrophotometry ····· 534
2.46 Residual Solvents ····························· 535
4.03 Digestion Test ································· 542
6.04 Test for Acid-neutralizing Capacity ofGastrointestinal Medicines ························ 5429.01 Reference Standards ·························· 543
9.41 Reagents, Test solution ······················· 543
9.42 Solid Supports/Column Packings for
Chromatography ···································· 547
３. Official Monographs(1) Addition
Acarbose ················································ 547
Acarbose Tablets ······································ 549
Chloramphenicol and Colistin Sodium
Methanesulfonate Ophthalmic Solution ········· 551
Clomipramine Hydrochloride Tablets ·············· 553
Clotiazepam Tablets ·································· 554
Entacapone ············································· 555
Entacapone Tablets···································· 556
Insulin Aspart (Genetical Recombination) ········· 558
Irbesartan Tablets······································ 560
Pazufloxacin Mesilate Injection ····················· 561
Pyridoxal Phosphate Hydrate ························ 562
Tramadol Hydrochloride ····························· 564
Zonisamide Tablets ··································· 565(2) Revision

Bacitracin ·············································· 566
Cellacefate ············································· 566
Dextran 40 ············································· 566
Digoxin ················································ 567
Doxorubicin Hydrochloride ························· 567
Ethanol ················································· 568
Anhydrous Ethanol ··································· 569
Folic Acid·············································· 570
Fosfomycin Calcium Hydrate ······················· 570
Fosfomycin Sodium ·································· 570
Heparin Calcium ······································ 571
Heparin Sodium······································· 572
Hydroxocobalamin Acetate ························· 573
Hydroxypropylcellulose ····························· 575
Iohexol Injection ······································ 575
Isosorbide Mononitrate 70%/Lactose 30% ········ 575
D-Mannitol ············································ 575
Anhydrous Lactose ··································· 575
Lactose Hydrate······································· 576
Noradrenaline ········································· 576
Polysorbate 80 ········································ 576
Povidone ··············································· 577
Saccharin Sodium Hydrate ·························· 577
Suxamethonium Chloride Injection ················ 577
Teicoplanin ············································ 577
Thrombin ·············································· 578
Vinblastine Sulfate ··································· 578
Vincristine Sulfate ···································· 578
４. Official Monographs－Crude Drugs(1) Addition
Goreisan Extract ······································ 578(2) Revision
Bakumondoto Extract ································ 580
Bofutsushosan Extract ······························· 582
Boiogito Extract ······································ 583Chotosan Extract······································ 584
Daiokanzoto Extract ·································· 586
Daisaikoto Extract ···································· 587
Goshajinkigan Extract ······························· 588
Hachimijiogan Extract ······························· 589
Hangekobokuto Extract ······························ 590
Hangeshashinto Extract ······························ 590

Hochuekkito Extract ·································· 592
Juzentaihoto Extract ·································· 595
Kakkonto Extract······································ 598
Kakkontokasenkyushin’i Extract ··················· 601
Kamikihito Extract ··································· 603
Kamishoyosan Extract································ 604Keishibukuryogan Extract ··························· 606
Maoto Extract ········································ 607
Mukoi-Daikenchuto Extract ························ 608
Orengedokuto Extract ······························· 609
Otsujito Extract ······································· 609
Rikkunshito Extract ··································· 610
Ryokeijutsukanto Extract ··························· 612
Saibokuto Extract ···································· 614
Saikokeishito Extract ································· 616
Saireito Extract ········································ 619
Shakuyakukanzoto Extract··························· 622
Shimbuto Extract ····································· 623
Shosaikoto Extract ···································· 624
Shoseiryuto Extract ··································· 626
Tokakujokito Extract ································ 629
Tokishakuyakusan Extract ·························· 630
Yokukansan Extract ·································· 631
５. Infrared Reference Spectra
Acarbose ··············································· 632
Entacapone ············································· 632
Pyridoxal Phosphate Hydrate ························ 633
Tramadol Hydrochloride ····························· 633
６. Ultraviolet-visible Reference Spectra
Entacapon ·············································· 634
Pyridoxal Phosphate Hydrate ························ 634
Tramadol Hydrochloride ····························· 634
７. General Information(1) AdditionCriteria for Content Uniformity in Real Time
Release Testing by Process Analytical
Technology ········································· 635
Enzyme-linked immunosorbent assay (ELISA) ·· 637(3) Revision
Powder Flow ··········································· 641
Solid and Particle Densities ·························· 641
Purity Tests on Crude Drugs using GeneticInformation ········································· 641
On the Scientific Names of Crude Drugs listed inthe JP · · ··············································643
Basic Concepts for Quality Assurance of Drug
Substances and Drug Products ··················· 643(4) Deletion
Laser Diffraction Measurement of Particle Size························································ 644
Additional Revision of the Revision Drafts for First
Supplement to JP 17

１. Official Monographs(1) Addition
Calcium Levofolinate Hydrate ······················ 644
Montelukast Sodium Granules ······················ 644
Revision Drafts for First Supplement to JP 17 regarding
the Monographs and so on Scheduled to be Deleted
１. General Tests, Processes and Apparatus
9.01 Reference Standards ·························· 645
9.41 Reagents, Test solution ······················· 645
２. Official Monographs(1) Deletion
Aceglutamide Aluminum ···························· 648
Diclofenamide ········································· 648
Diclofenamide Tablets ································ 648
Digitoxin ··············································· 648
Digitoxin Tablets ······································ 648
Fluoxymesterone ······································ 648
Gramicidin ············································· 648
Lanatoside C ··········································· 648
Lanatoside C Tablets·································· 648
Mercurochrome ········································ 648
Mercurochrome Solution ····························· 648
Rokitamycin ··········································· 648
Rokitamycin Tablets ·································· 648
Serrapeptase ············································ 648
Tolazamide ············································· 648
Zinostatin Stimalamer ································ 648
３. Official Monographs－Crude Drugs(1) Deletion
Scopolia Extract, Papaverine and Ethyl
Aminobenzoate Powder ··························· 648
４. Infrared Reference Spectra
Diclofenamide ········································· 648
Fluoxymesterone ······································ 648
Rokitamycin ··········································· 648
Tolazamide ············································· 648
５. Ultraviolet-visible Reference Spectra
Diclofenamide ········································· 648
Fluoxymesterone ······································ 648
Gramicidin ············································· 648
Rokitamycin ··········································· 648
Tolazamide ············································· 648

Pharmacopoeial Harmonization
１. Official Inquiry Stage Draft(1)Revision①Anhydrous Dibasic Calcium Phosphate(Rev.2) ·· 485②Microcrystalline Cellulose(Rev.3) ·················· 488③Hypromellose(Rev.2) ································· 492④Methylcellulose(Rev.2) ······························ 498

Useful Information
PMRJ Reference Standards Ordering Information
for Foreign Users ··········································· 649

Publishing Schedule (Vol.25, No.4): December 2016