Japanese Pharmacopoeial Forum
Vol. 24

No. 1March 2015

Contents

Revision Drafts
Drafts for JP 17
１. General Tests, Processes and Apparatus(1) Revision
2.21 Nuclear Magnetic Resonance Spectroscopy·························································· 156
２. Official Monographs(1) Addition
Diflorasone Diacetate ··································· 159
Haloperidol Injection ··································· 160
Irbesartan ················································· 161
Isomalt Hydrate ·········································· 162
Medroxyprogesterone Acetate ························· 165
Purified Sodium Hyaluronate Ophthalmic Solution·························································· 166
Sodium L-Lactate Ringer’s Solution ················· 168
Terbinafine Hydrochloride Tablets ··················· 171
Valaciclovir Hydrochloride ···························· 172
Valaciclovir Hydrochloride Tablets ·················· 175(2) Revision
Aminophylline Hydrate ································· 176
Aminophylline Injection································ 176
Ampicillin Sodium ······································ 176
Calcium Folinate ········································ 178
Chloramphenicol Sodium Succinate ·················· 178
Cloxacillin Sodium Hydrate ··························· 178
Enviomycin Sulfate ····································· 179
Epoetin Alfa (Genetical Recombination) ············ 179
Epoetin Beta (Genetical Recombination) ············ 181
Ethambutol Hydrochloride ····························· 181
Ethanol ···················································· 181
Anhydrous Ethanol ······································ 182
Ethanol for Disinfection ································ 182
Filgrastim (Genetical Recombination) ··············· 182
Filgrastim (Genetical Recombination) Injection ···· 184
Hydroxyzine Pamoate ·································· 184
Kitasamycin Tartrate ···································· 184
Lenograstim (Genetical Recombination) ············ 185
Nartograstim (Genetical Recombination) ············ 186

Nartograstim for Injection(Genetical Recombination)·························································· 186
Pyrantel Pamoate ········································ 186
Rice Starch ··············································· 186
Roxithromycin ··········································· 187
Saccharin ················································· 188
Sodium Aurothiomalate ································ 188
Sodium Chloride ········································ 188
Purified Sodium Hyaluronate ························· 189
Sodium Prasterone Sulfate Hydrate ·················· 190
Sodium Starch Glycolate ······························· 190
Teceleukin for Injection (Genetical Recombination)·························································· 190
Wine······················································· 191
３. Official Monographs－Crude Drugs(1) Addition
Codonopsis Root ········································ 191
Hedysarum Root ········································ 192
Kamikihito Extract ······································ 192
Salvia Miltiorrhiza Root ······························· 197(2) Revision
Daisaikoto Extract ······································ 197
Hochuekkito Extract ···································· 198
Orengedokuto Extract ·································· 198
Otsujito Extract ·········································· 199
Peucedanum Root ······································· 202
Prepared Glycyrrhiza ··································· 202
Saibokuto Extract ······································· 203
Saikokeishito Extract ··································· 203
Saireito Extract ·········································· 204
Shosaikoto Extract ······································ 204
Shoseiryuto Extract ····································· 205
４. Infrared Reference Spectra
Diflorasone Diacetate··································· 206
Eplerenone ··············································· 206
Hydroxypropylcellulose ································ 206
Irbesartan ················································· 207
Lansoprazole ············································· 207
Medroxyprogesterone Acetate ························ 207
Miglitol ··················································· 208

Valaciclovir Hydrochloride ···························· 208
Voriconazole ············································· 208
５. Ultraviolet-visible Reference Spectra
Eplerenone ················································ 209
Irbesartan ················································· 209
Lansoprazole ············································· 209
Medroxyprogesterone Acetate ························· 210
Valaciclovir Hydrochloride ···························· 210
Voriconazole ············································· 210
６. General Information(1) Addition
Analytical methods for aflatoxins in crude drug andits product·············································· 211
Notification for the quantitative marker constituentsof crude drugs and crude drug preparations ······ 212(2) Revision
Disinfection and Sterilization Methods ·············· 214
Quantitative Analytical Technique Utilizing
NuclearMagneticResonance(NMR)
Spectroscopy and Its Application to Reagents inthe Japanese Pharmacopoeia ························ 217
Additional Revision of the Revision Drafts for JP 17
１. Official Monographs(1) Revision
Doxycycline Hydrochloride Tablets ················· 219
Lansoprazole ············································· 220
Purified Sodium Hyaluronate Injection ·············· 220
２. Official Monographs－Crude drugs(1) RevisionCoptis Rhizome ········································· 223
Powdered Coptis Rhizome····························· 223

Pharmacopoeial Harmonization
１. Official Inquiry Stage Draft(1) Monographs
1)Addition①Propylene Glycol ······································· 113
２. Harmonized Document(1) Monographs
1)Revision・Correction①Glucose Monohydrate (Corr.1) ······················· 121

Useful Information
PMRJ Reference Standards Ordering Information forForeign Users ················································· 224

Publishing Schedule (Vol.24, No.2): June 2015