Japanese Pharmacopoeial Forum
Vol. 24

No. 3

September 2015

Contents

Revision Drafts
Revision Drafts on Dissolution for First Supplement toJP 17
㸯. Official Monographs(1) Addition
Entacapone Tablets····································· 636
Pentobarbital Calcium Tablets ························ 636
Revision Drafts for First Supplement to JP 17
㸯. General Tests, Processes and Apparatus(1) Revision
9.41 Reagents, Test solution ························ 637
㸰. Official Monographs(1) Addition
Cefoperazone Sodium for Injection ·················· 640
Chlorpromazine Hydrochloride, Phenobarbitaland Promethazine Hydrochloride Tablets ········ 641(2) Revision
Amoxicillin Hydrate ··································· 645
Cefixime Hydrate······································· 646
Clarithromycin ·········································· 647
Colistin Sodium Methanesulfonate ·················· 648
Demethylchlortetracycline Hydrochloride ·········· 648
Erythromycin ··········································· 649
Gentamicin Sulfate ····································· 650
Hydrocortisone Acetate································ 650
Oxytetracycline Hydrochloride ······················· 650
Spiramycin Acetate ···································· 650
Tetracycline Hydrochloride ··························· 650
Tobramycin ············································· 651
㸳. Official Monographs㸫Crude Drugs(1) Revision
Powdered Alisma Tuber ······························· 651
Cornus Fruit ············································· 652
Goshajinkigan Extract ································· 652
Hachimijiogan Extract ································· 653
Rape Seed Oil ··········································· 653
Powdered Sweet Hydrangea Leaf ···················· 653
㸲. Infrared Reference Spectra
Oxytetracycline Hydrochloride ······················· 654
Drafts for JP 17

㸯. General Rules for Crude Drugs ·························· 654
㸰. General Tests, Processes and Apparatus(1) Addition
2.65 Methods for Color Matching ················· 655
6.12
Release Test for Preparations forCutaneous Application ······························ 657
9.41 Reagents, Test solution ························ 660(2) Revision
2.46 Residual Solvents······························· 661
2.60 Melting Point Determination ················· 668
9.01 Reference Standards ··························· 670
9.23 Matching Fluids for Color····················· 671
9.41 Reagents, Test solution ························ 672
9.44 Standard Particles, etc. ························· 681
㸱. Official Monographs(1) Revision
Stearic Acid ············································· 681
㸴. General Information(1) Addition
Basic Concept of Quality Risk Management ······· 681
Standard Procedure for Mechanical Calibrationof Dissolution Apparatus ··························· 685(2) Deletion
Guideline for Residual Solvents and Models for
the Residual Solvents Test ························· 687
Additional Revision of the Revision Drafts for JP 17
㸯. General Tests, Processes and Apparatus(1) Revision
9.41 Reagents, Test solution ························ 687
㸰. Official Monographs(1) Addition
Dexamethasone Sodium Phosphate ·················· 690
Ribavirin ················································· 690
Ribavirin Capsules ····································· 691
Sultamicillin Tosilate Tablets ························· 691(2) Revision
Diarsenic Trioxide ······································ 692
㸱. Official Monographs㸫Crude drugs(1) Revision
Bakumondoto Extract ·································· 692

Belladonna Root ········································ 692
Chotosan Extract ······································· 692
Coptis Rhizome ········································· 693
Powdered Coptis Rhizome ···························· 693Daisaikoto Extract ······································ 693
Glycyrrhiza ·············································· 694
Powdered Glycyrrhiza ································· 694
Hangeshashinto Extract································ 694
Hochuekkito Extract ··································· 694
Juzentaihoto Extract···································· 695
Kakkonto Extract ······································· 695
Kakkontokasenkyushin'i Extract ····················· 696
Peony Root ·············································· 696
Powdered Peony Root ································· 696
Phellodendron Bark ···································· 696
Powdered Phellodendron Bark ······················· 697
Compound Phellodendron Powder for Cataplasm 697
Phellodendron, Albumin Tannate andBismuth
Subnitrate Powder ······································ 697
Pueraria Root ··········································· 697
Rikkunshito Extract ···································· 698
Saibokuto Extract······································· 698
Saikokeishito Extract ·································· 698
Saireito Extract ········································· 699
Scopolia Rhizome ······································ 699
Scopolia Extract and Ethyl Aminobenzoate
Powder ················································ 699
Scutellaria Root ········································· 700
Powdered Scutellaria Root ···························· 700

Senna Leaf ··············································· 700
Powdered Senna Leaf ·································· 701
Shakuyakukanzoto Extract ···························· 701
Shimbuto Extract ······································· 701
Shosaikoto Extract······································ 701
Shoseiryuto Extract····································· 702
Swertia Herb ············································ 702
Powdered Swertia Herb ································ 702
Swertia and Sodium Bicarbonate Powder ··········· 702
Tokishakuyakusan Extract ···························· 703
Errata of the revision drafts for JP 17, published at
somewhere in the JP Forum㸯. GENERAL NOTICES ···································· 703

Pharmacopoeial Harmonization
㸯㸬Harmonized Document(1) Monographs
1)Revision࣭CorrectionձHydroxypropylcellulose, low substtituted (Corr.1) 590
ղHypromellose(Rev.1㸪Corr.2) ······················· 591
ճMetylcellulose(Rev.2㸪Corr.2) ······················ 592
մPovidone(Rev.1) ······································· 593
յStearic Acid(Rev.1㸪Corr.1) ························ 603

Useful Information
PMRJ Reference Standards Ordering Information for
Foreign Users ················································ 704

Publishing Schedule (Vol.24, No.4): December 2015