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

Vol. 27

No. 2June 2018

目次Contents
改正案

Revision Drafts

第十八改正日本薬局方に収載予定の改正案（意見募集）
その 1
１. 一般試験法(1) 既収載
9.41 試薬・試液 ······································· 217
第十八改正日本薬局方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
2.58 粉末Ｘ線回折測定法 ··························· 218
２. 医薬品各条(1) 新収載
ミグリトール錠 ········································· 222
３. 医薬品各条（生薬等）(1) 既収載
ガジュツ ·················································· 223
ソウジュツ ··············································· 223
４. 参考情報(1) 既収載
日本薬局方収載生薬の学名表記について········· 223
第十七改正日本薬局方第二追補に収載予定の改正案の追加改定（意見募集）
１. 医薬品各条(1) 既収載
ヒドロコルチゾン ······································ 224
第十七改正日本薬局方第二追補に収載予定の改正案（報告）１. 製剤総則 ·················································· 224
第十七改正日本薬局方第二追補に収載予定の見送りについて（報告）１. 医薬品各条（化学薬品等）(1) 新収載
デキサメタゾンリン酸エステルナトリウム······ 225
第十七改正日本薬局方第二追補に収載予定の取りやめについて（報告）１. 製剤総則 ·················································· 225

日本薬局方から削除予定の項目について（報告）１. 医薬品各条（化学薬品等）(1) 削除乾燥破傷風ウマ抗毒素 ································· 226
沈降はぶトキソイド ···································· 226
２. 参考情報(1) 削除最終滅菌医薬品のパラメトリックリリース ······ 226
培地充塡試験（プロセスシミュレーション） ··· 226
無菌医薬品製造区域の環境モニタリング法 ······ 226

日本薬局方技術情報
Japanese Pharmacopoeial Technical Information

英訳 第十八改正日本薬局方原案作成要領(Guideline for drafting The JapanesePharmacopoeia, Eighteenth Edition) ··············· 227

薬局方関連通知など

Authority Announcements

日本薬局方収載原案意見募集（平成 30 年 6 月分）に係るカラム情報の公開について ·························· 302
日本薬局方医薬品各条（生薬等）原案に係るカラムの情報の公開について ········································· 303
日本薬局方から削除する医薬品各条について········· 321
日本薬局方参考情報の GMP 関連事項の取扱いについて································································· 321

国際調和

Pharmacopoeial Harmonization

1.国際調和案(PDG Stage 2 (旧 Stage 4))(1)試験法
① Characterisation of Crystalline and Partially
Crystalline Solids by X-Ray Powder Diffraction····························································· 322
粉末Ｘ線回折測定法 ································· 330

海外薬局方情報

Foreign Pharmacopoeial Information

注射剤のゴム栓試験法〈381〉改正の必要性及び改正ポイント ························································· 336

ii
局方迅速無菌試験法の開発 ····························· 342

標準品のご案内

Useful Information

アメリカ薬局方標準品の取次販売のご案内 ········ 370
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 ··································· 372

日本薬局方等標準品の頒布のご案内·················· 353～～～～～～～～～～～～～～～

Contents in English
Revision Drafts
Drafts for JP 18
１. General Tests, Processes and Apparatus(1) Revision
9.41 Reagents, Test Solutions ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 378
２. Official Monographs(1) Addition
Miglitol Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 378
３. Official Monographs－Crude Drugs(1) Revision
Atractylodes Lancea Rhizome ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 380
Zedoary ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 380
４. General Information(1) Revision
On the Scientific Names of Crude Drugs listed in the JPꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 380
Revision Drafts for Second Supplement to JP 17
１. General Rules for Preparations ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 381
２. General Tests, Processes and Apparatus(1) Revision
2.46 Residual Solvents ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 381
３. General Information(1) Addition
Control of Elemental Impurities in Drug Products ꞏ 388
Glossary for Quality by Design (QbD), Quality RiskManagement (QRM) and Pharmaceutical Quality
System (PQS) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 393
Host Cell Protein Analysis ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 396(2) Revision
Purity Tests on Crude Drugs using Genetic Informationꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 399
Additional Revision of the Revision Drafts for SecondSupplement to JP 17
１. Official Monographs(1) Addition
Hydrocortisone ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 405

Cancel of Revision Drafts for Second Supplement to JP 17
１. Official Monographs(1) Addition
Dexamethasone Sodium Phosphate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 406
Cancel of the Draft for JP
１. General Rules for Preparations ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 406
Drafts to JP regarding the Monographs and so on
Scheduled to be Deleted
１. Official Monographs(1) Deletion
Adsorbed Habu-venom Toxoid ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 407
Freeze-dried Tetanus Antitoxin, Equine ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 407
２. General Information(1) Deletion
Media Fill Test (Process Simulation) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 407
Microbiological Environmental Monitoring Methods ofProcessing Areas for Sterile Pharmaceutical Productsꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 407
Parametric Release of Terminally Sterilized
Pharmaceutical Products ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 407

Authority Announcements
Information about Columns for Japanese Pharmacopoeia
Draft Monographs (Chemical Drug) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 408

Pharmacopoeial Harmonization
1. PDG Stage 2(former Stage 4) Draft for Official Inquiry(1) General Tests①Characterisation of Crystalline and Partially Crystalline
Solids by X-Ray Powder Diffracction ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 322

Useful Information
PMRJ Reference Standards Ordering Information for
Foreign Users ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 411

次号（27 巻 3 号）出版月：2018 年 9 月
Publishing Schedule (Vol.27, No.3): September 2018