日本薬局方フォーラム
Japanese Pharmacopoeial Forum

Vol. 29

No. 3

September 2020

目次Contents
改正案

Revision Drafts

第十八改正日本薬局方第一追補に収載予定の改正案（意見募集）
１. 一般試験法(1) 既収載
9.41 試薬・試液 ······································· 203
第十八改正日本薬局方第一追補に収載予定の改正案（意見募集）
１. 一般試験法(1) 既収載
9.41 試薬・試液 ······································· 204
２. 医薬品各条（化学薬品等）(1) 新収載
テモゾロミド ············································ 205
テモゾロミドカプセル ································ 206
注射用テモゾロミド ··································· 208(2) 既収載
カルメロースナトリウム ····························· 209
ステアリン酸 ············································ 211
精製白糖 ·················································· 211
３. 医薬品各条（生薬等）(1) 既収載
ヤクチ ····················································· 212
４. 参照紫外可視吸収スペクトル
テモゾロミド ············································ 213
５. 参照赤外吸収スペクトル
カルメロースナトリウム ····························· 213
テモゾロミド ············································ 214
既収載品目（医薬品各条(生薬等)）の定量法の改正について（意見募集）
キョウニン ··············································· 214
桂枝茯苓丸エキス ······································ 214
桃核承気湯エキス ······································ 214
トウニン ·················································· 214
トウニン末 ··············································· 214
麻黄湯エキス ············································ 214

日本薬局方から削除する医薬品各条について（報告）
ガスえそウマ抗毒素 ···································· 215
コレラワクチン ·········································· 215
ジフテリア破傷風混合トキソイド ·················· 215
日本脳炎ワクチン ······································· 215
乾燥日本脳炎ワクチン ································· 215
経口生ポリオワクチン ································· 215
ワイル病秋やみ混合ワクチン ························ 215

薬局方関連通知など

Useful Information

日本薬局方収載原案意見募集（令和 2 年 9 月分）に係るカラム情報の公開について ····························· 216

国際調和

Pharmacopoeial Harmonization

１. Stage 2 案 (Official Inquiry Stage Draft)(1) 各条
1)新規①Carboxymethylcellulose Sodium················ 217
カルボキシメチルセルロースナトリウム ······ 2212)改正①Stearic Acid ··········································· 224
ステアリン酸 ·········································· 227②Sucrose ················································· 230
精製白糖 ················································ 234

海外薬局方情報

Foreign Pharmacopoeial Information

エンドトキシン測定用遺伝子組換え C 因子試薬の医薬品への適用及びライセート試薬との同等性 ·············· 237

標準品のご案内

Reference Standards

日本薬局方等標準品の頒布のご案内 ·················· 242
USP 標準品の取次販売のご案内 ······················· 251
LGC Standards 社不純物標準物質等および EP 標準品の取次販売のご案内 ···································· 253

ii～～～～～～～～～～～～～～～

Contents in English
Revision Drafts
Revision Drafts for First Supplement to JP 18
１. General Tests, Processes and Apparatus(1) Revision
9.41 Reagents, Test Solutions ······················ 257
２. Official Monographs(1) Addition
Temozolomide ·········································· 258
Temozolomide Capsules ······························ 260
Temozolomide for Injection ·························· 262(2) Revision
Carmellose Sodium ···································· 264
Stearic Acid ············································· 266
Sucrose··················································· 266
３. Official Monographs－Crude Drugs(1) Revision
Bitter Cardamon ········································ 268
４. Infrared Reference Spectra
Carmellose Sodium ···································· 269
Temozolomide ·········································· 269
５. Ultraviolet-visible Reference Spectra
Temozolomide ·········································· 270
Revision of the assay of crude drugs for listed articles(official monographs)
Apricot Kernel ·········································· 271
Keishibukuryogan ······································ 271
Maoto Extract ··········································· 271
Peach Kernel ············································ 271
Powdered Peach Kernel ······························· 271
Tokakujokito Extract··································· 271

Drafts to JP regarding the Monographs Scheduled to beDeleted
１. Official Monographs(1) Deletion
Cholera Vaccine········································ 272
Diphtheria-Tetanus Combined Toxoid ·············· 272
Gas Gangrene Antitoxin, Equine ···················· 272
Japanese Encephalitis Vaccine ······················· 272
Freeze-dried Japanese Encephalitis Vaccine ······· 272
Live Oral Poliomyelitis Vaccine ····················· 272
Weil’s Disease and Akiyami Combined Vaccine·· 272

Reference Standards
PMRJ Reference Standards Ordering Information
for Foreign Users ······································ 273

Pharmacopoeial Harmonization
１.PDG Stage 2(1) Monographs
1)Addition①Carboxymethylcellulose Sodium ··············· 217
2)Revision①Stearic Acid ·········································· 224②Sucrose················································· 230

次号（29 巻 4 号）出版月：2020 年 12 月
Publishing Schedule (Vol.29, No.4): December 2020