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

Vol. 26

No. 2June 2017

目次Contents

改正案

Revision Drafts

第十七改正日本薬局方第二追補に収載予定の改正案（意見募集）その１
１. 製剤総則 ·················································· 229
２. 一般試験法(1) 新収載
6.16 半固形製剤の流動学的測定法 ··············· 229
第十七改正日本薬局方第二追補に収載予定の改正案（意見募集）その２
１. 一般試験法(1) 既収載
9.41 試薬・試液 ······································· 234
２. 医薬品各条(1) 新収載
シロップ用クラリスロマイシン····················· 236
ゲンタマイシン硫酸塩注射液························ 237
ゲンタマイシン硫酸塩軟膏 ·························· 237(2) 既収載
イソマル水和物 ········································· 238
クロラムフェニコール ································ 240
テイコプラニン ········································· 240
３. 医薬品各条（生薬等）(1) 既収載
キキョウ ·················································· 240
キキョウ末 ··············································· 240
ゴオウ ····················································· 241
当帰 薬散エキス······································· 242
ボウイ ····················································· 242
防已黄耆湯エキス ······································ 242
ボウフウ ·················································· 243

第十七改正日本薬局方第一追補に収載予定の見送りについて（報告）１. 参考情報(1) 新収載
原薬及び製剤の不純物に関するガイドライン ··· 244
日本薬局方に収載予定の取りやめについて（報告）１. 医薬品各条（化学薬品等）(1) 新収載
クロルプロマジン塩酸塩・フェノバルビタール・プロメタジン塩酸塩錠 ······························ 245

薬局方関連通知など

Authority Announcements

第十七改正日本薬局方の制定に伴う医薬品等の承認申請等に関する質疑応答集（Ｑ＆Ａ）について······ 246

国際調和

Pharmacopoeial Harmonization

１. Stage 4 案(Official Inquiry Stage Draft)(1) 各条①Calcium Carbonate ································· 250
炭酸カルシウム ······································· 253

海外薬局方情報

Foreign Pharmacopoeial Information

分析法目標プロファイル：分析法ライフサイクルを通じた構成と適用 ··············································· 255
マイクロメーター以下の領域の粒子の分析ギャップと課
題 ······························································ 267

標準品のご案内

Useful Information

日本薬局方等標準品の頒布のご案内 ···················· 278
アメリカ薬局方標準品の取次販売のご案内············ 292
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 ······································ 294

ii～～～～～～～～～～～～～～～

Contents in English

Revision Drafts
Revision Drafts for Second Supplement to JP 17
１. General Rules for Preparations ··························· 299
２. General Tests, Processes and Apparatus(1) Addition
6.16
Rheological Measurements for Semi-solid
Preparations ·········································· 299(2) Revision
9.41 Reagents, Test Solutions ························· 303
３. Official Monographs(1) Addition
Clarithromycin for Syrup ······························ 306
Gentamicin Sulfate Injection ·························· 307
Gentamicin Sulfate Ointment ························· 308(2) Revision
Chloramphenicol ········································ 308
Isomalt Hydrate ········································· 309
Teicoplanin ·············································· 311
４. Official Monographs－Crude Drugs(1) Revision
Boiogito Extract ········································· 311
Oriental Bezoar ········································· 312
Platycodon Root ········································ 313
Powdered Platycodon Root ···························· 314
Saposhnikovia Root and Rhizome ···················· 314
Sinomenium Stem and Rhizome ······················ 315
Tokishakuyakusan Extract ····························· 315

Revision Drafts for First Supplement to JP 17
１. Official Monographs－Crude Drugs(1) Revision
Yokukansan Extract ···································· 316
Cancel of Revision Drafts for First Supplement to JP 17
１. General Information(1) Addition
Guideline on impurities in drug substances andpreparations ·········································· 317
Cancel of the Draft for JP
１. Official Monograph(1) Addition
Chlorpromazine Hydrochloride ･ Phenobarbital ･Promethazine Hydrochloride Tablets ············· 317

Pharmacopoeial Harmonization
１. Official Inquiry Stage Draft(1) Monograph①Calcium Carbonate ·································· 250

Useful Information
PMRJ Reference Standards Ordering Information for Foreign
Users··························································· 318

次号（26 巻 3 号）出版月：2017 年 9 月
Publishing Schedule (Vol.26, No.3): September 2017