Japanese Pharmacopoeial Forum
Vol. 23

No. 4December 2014

Contents

Revision Drafts
Drafts for JP 17
１. General Tests, Processes and Apparatus(1) Revision
5.02 Microbial Limit Test for Crude Drags ········· 820
6.06 Foreign Insoluble Matter Test for
Injections ··························································· 832
9.41 Reagents, Test solution ······························· 832(2) Deletion
8.01 Sterilization and Aseptic ····························· 835
２. Official Monographs(1) Addition
Candesartan Cilexetil and Hydrochlorothiazide
Tablets ······························································· 835
Cefoperazone Sodium-Sulbactam Sodium for
Injection····························································· 840
Doxycycline Hydrochloride Tablets······················· 842
Eplerenone····························································· 844
Eplerenone Tablets ················································ 845
Felbinac Tape ························································ 847
Lansoprazole ························································· 847
Lansoprazole Delayed-release Capsules················· 849
Lansoprazole Delayed-release Orally
Disintegration Tablets ········································ 850
Miglitol ································································· 852
Montelukast Sodium Tablets ································· 854
Montelukast Sodium Chewable Tablets ················· 856
Panipenem and Betamipron for Injection ··············· 858
Pioglitazone Hydrochloride and Glimepiride
Tablets ······························································· 860
Silodosin Tablets ··················································· 864
Spectinomycin Hydrochloride for Injection ··········· 867
Sultamicillin Tosilate Tablets ································ 867
Voriconazole ························································· 869
Voriconazole Tablets ············································· 871(2) Revision
Bacampicillin Hydrochloride ································· 872
Cefaclor Compound Granules································ 873
Cetirizine Hydrochloride Tablets ··························· 873
Panipenem ····························································· 874(3) Deletion
Chlorpheniramine and Calcium Powder················· 874
Estradiol Benzoate Injection ·································· 874
Griseofulvin··························································· 874
Griseofulvin Tablets ·············································· 874
Siccanin································································· 874
Vitamin A Oil Capsules········································· 874
３. Official Monographs－Crude Drugs(1) Addition
Bofutsushosan Extract ··········································· 874
Boiogito Extract ···················································· 880
Tokakujokito Extract ············································· 883
Yokukansan Extract··············································· 887(2) Revision
Anemarrhena Rhizome ·········································· 891
Bakumondoto Extract ············································ 891
Chotosan Extract ··················································· 891
Dioscorea Rhizome················································ 891
Powdered Dioscorea Rhizome ······························· 892
Forsythia Fruit ······················································· 892
Glycyrrhiza···························································· 893
Powdered Glycyrrhiza ··········································· 893
Goshajinkigan Extract ··········································· 893
Hachimijiogan Extract ··········································· 893
Hangekobokuto Extract ········································· 893
Hangeshashinto Extract ········································· 893
Hochuekkito Extract ·············································· 893
Juzentaihoto Extract ·············································· 893
Kakkonto Extract··················································· 893
Kakkontokasenkyushin'i Extract ···························· 894
Kamishoyosan Extract ··········································· 894
Keishibukuryogan Extract ····································· 894
Maoto Extract ························································ 894
Orengedokuto Extract ············································ 894
Rikkunshito Extract ··············································· 895
Ryokeijutsukanto Extract······································· 895
Saibokuto Extract ·················································· 895
Saikokeishito Extract ············································· 895
Shosaikoto Extract················································· 895
Shoseiryuto Extract················································ 896

Shakuyakukanzoto Extract ····································· 896
Tokishakuyakusan Extract ····································· 896
Zanthoxylum Fruit ················································· 896
Powdered Zanthoxylum Fruit································· 896
３. General Information(1) Revision
Mycoplasma Testing for Cell Substrates used
for the Production of Biotechnological/
Biological Products ············································ 896
Microbial Attributes of Non-sterile
Pharmaceutical Products····································· 901
Additional Revision of the Revision Drafts for JP 17
１. Official Monographs(1) Revision
Spectinomycin Hydrochloride Hydrate ·················· 903
２. Official Monographs－Crude drugs(1) Revision
Glycyrrhiza ···························································· 904
Powdered Glycyrrhiza············································ 905

Pharmacopoeial Harmonization
１. Harmonized Document(1) Monographs1)Addition①Hydroxypropylcellulose, Low Substituted ············· 770②Sodium Lauryl Sulfate··········································· 774
2)Revision, Correction①Polysorbate 80 (Corr.2) ········································· 779②Saccharin Sodium (Rev.2) ····································· 787③Stearic Acid (Rev.1, Corr.1) ·································· 793

Useful Information
PMRJ Reference Standards Ordering Information forForeign Users ······························································· 906

Cumulative Contents
Vol.23 Cumulative Contents ·································· 927

Publishing Schedule (Vol.24, No.1): March 2015