Japanese Pharmacopoeial Forum
Vol. 23

No. 2June 2014

Contents

Revision Drafts
Revision Drafts on Dissolution, etc. for JP 17
１. Official Monographs(1) Addition
Lansoprazole Delayed-release Capsules ············ 214
Lansoprazole Delayed-release Orally Disintegration
Tablets ·················································· 214
Sultamicillin Tosilate Tablets························· 214
Drafts for JP 17
１. General Tests, Process and Apparatus(1) Revision
2.52 Thermal Analysis ······························ 215
3.01 Determination of Bulk and Tapped Densities··························································· 217
5.01 Crude Drugs Test······························· 218
9.41 Reagents, Test Solutions ······················ 218
２. Official Monographs(1) Addition
Ascorbic Acid and Calcium Pantothenate Tablets··························································· 218Cefpodoxime Proxetil for Syrup ····················· 220
Fosfomycin Calcium for Syrup ······················· 222
Interferon Alfa (NAMALWA) ······················· 223
Interferon Alfa (NAMALWA) Injection············ 230
Ticlopidine Hydrochloride Tablets ·················· 232(1) Revision
Epalrestat ················································ 234
Lincomycin Hydrochloride Hydrate ················· 234
Metenolone Enanthate Injection ····················· 234
３. Official Monographs－Crude Drugs(1) Addition
Sodium Sulfate Hydrate ······························· 234
Anhydrous Sodium Sulfate ··························· 235(2) Revision
Acacia ···················································· 236
Powdered Acacia ······································· 236
Asparagus Tuber ········································ 236
Astragalus Root ········································· 236
Bakumondoto Extract ·································· 236
Cimicifuga Rhizome ··································· 237

Hochuekkito Extract ··································· 238
Powdered Japanese Gentian ·························· 238
Juzentaihoto Extract ···································· 238
Mukoi-Daikenchuto Extract ·························· 239
Ophiopogon Tuber ····································· 240
Otsujito Extract ········································· 240
Rikkunshito Extract ···································· 240
Additional Expression for Water Determination ofReference Standard used in Assay of Crude Drugs
Bakumondoto Extract ·································· 241
Chotosan Extract········································ 241
Daiokanzoto Extract ··································· 241
Daisaikoto Extract ······································ 241
Ginseng ·················································· 241
Powdered Ginseng······································ 241
Glycyrrhiza ·············································· 241
Powdered Glycyrrhiza ································· 241
Glycyrrhiza Extract ···································· 241
Crude Glycyrrhiza Extract ···························· 241
Goshajinkigan Extract ································· 241
Hachimijiogan Extract ································· 241
Hangekobokuto Extract ································ 242
Hochuekkito Extract ··································· 242
Juzentaihoto Extract ···································· 242
Kakkonto Extract ······································· 242
Kakkontokasenkyushin’i Extract ····················· 242
Kamishoyosan Extract ································· 242
Keishibukuryogan Extract ····························· 242
Maoto Extract ··········································· 242
Mukoi-Daikenchuto Extract ·························· 242
Orengedokuto Extract ·································· 242
Otsujito Extract ········································· 242
Peony Root ·············································· 242
Powdered Peony Root ································· 242
Prepared Glycyrrhiza ·································· 242
Pueraria Root ············································ 242
Red Ginseng ············································· 242
Rhubarb ·················································· 242
Powdered Rhubarb ····································· 242
Rikkunshito Extract ···································· 242

iiRyokeijutsukanto Extract······························ 242
Saibokuto Extract ······································· 242
Saikokeishito Extract ·································· 242
Saireito Extract·········································· 242
Scutellaria Root ········································· 242
Powdered Scutellaria Root ···························· 242
Senna Leaf ··············································· 242
Powdered Senna Leaf ·································· 243
Shakuyakukanzoto Extract ···························· 243
Shimbuto Extract ······································· 243
Shosaikoto Extract ····································· 243
Shoseiryuto Extract ···································· 243
Swertia Herb ············································ 243
Powdered Swertia Herb ······························· 243
Tokishakuyakusan Extract ···························· 243

Additional Revision of the Revision Drafts for JP 17
１. Official Monographs(1) Addition
Ciprofloxacin ············································ 244
Ciprofloxacin Hydrochloride Hydrate ··············· 245
Errata of the revision drafts for JP 17, published atsomewhere in the JP ForumCapsicum ················································ 245
Powdered Capsicum ··································· 245

Pharmacopoeial Harmonization
１. Official Inquiry Stage Draft(1) Revision①Peptide Mapping ···································· 165
Useful Information
PMRJ Reference Standards Ordering Information
for Foreign Users····································· 246

Publishing Schedule (Vol.23, No.3): September 2014