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

Vol. 30

No. 3

September 2021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) 新収載
2.28 円偏光二色性測定法 ···························· 291(2) 既収載
9.41 試薬・試液 ········································ 292
２. 参考情報(1) 新収載
製剤に関連する添加剤の機能性関連特性について〈G9-1-181〉 ············································· 296(2) 既収載
化学合成される医薬品原薬及びその製剤の不純物に関する考え方〈G0-3-181〉 ··························· 297
既収載品目（医薬品各条(生薬等)）の定量法の秤取量（MS）に 「qNMR で含量換算した」を追記する改正について（意見募集）
呉茱萸湯エキス ········································· 299
ショウキョウ ············································ 299
ショウキョウ末 ········································· 299
真武湯エキス ············································ 299
半夏厚朴湯エキス ······································ 299
カンキョウ ··············································· 299
無コウイ大建中湯エキス ····························· 299
牛車腎気丸エキス ······································ 299
サンシュユ ··············································· 299
八味地黄丸エキス ······································ 299
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
6.07 注射剤の不溶性微粒子試験法 ················ 299(2) 削除6.17 タンパク質医薬品注射剤の不溶性微粒子試験
法 ··························································· 302

２. 医薬品各条（化学薬品等）(1) 新収載
アナストロゾール錠 ···································· 302
ビカルタミド錠 ·········································· 303(2) 既収載
ステアリン酸マグネシウム ··························· 304
パラオキシ安息香酸エチル ··························· 306
パラオキシ安息香酸ブチル ··························· 307
パラオキシ安息香酸プロピル ························ 308
パラオキシ安息香酸メチル ··························· 310
３. 医薬品各条（生薬等）(1) 既収載
ゴボウシ ··················································· 311
シャカンゾウ ············································· 311
クロマトグラフィーに関連する一般試験法案及び参考情報案について
１. 一般試験法(1) 新収載
2.00 クロマトグラフィー総論 ······················· 312(2) 既収載
2.01 液体クロマトグラフィー ····················· 320
2.02 ガスクロマトグラフィー ····················· 323
２. 参考情報(1) 新収載
クロマトグラフィーのライフサイクル各ステージにおける管理戦略と変更管理の考え方(クロマトグラ
フィーのライフサイクルにおける変更管理)〈G1-5181〉 ······················································· 325
第十八改正日本薬局方第一追補において削除予定の医薬品各条等について（意見募集）
１. 一般試験法(1) 削除9.01 標準品 ··············································· 327
9.41 試薬・試液 ········································· 327
2. 医薬品各条（化学薬品等）(1) 削除ナルトグラスチム(遺伝子組換え) ··················· 327
注射用ナルトグラスチム(遺伝子組換え) ·········· 327

ii

第十八改正日本薬局方第一追補に収載予定の改正案（報告）1. 医薬品各条（化学薬品等）(1) 既収載
コムギデンプン ·········································· 328
ベンジルアルコール ···································· 328
ポリソルベート 80 ······································ 328第十八改正日本薬局方第一追補に収載予定の追加改正（報告）
1. 医薬品各条（化学薬品等）(1) 既収載
黄色ワセリン ············································· 331
白色ワセリン ············································· 332

薬局方関連通知など

Briefing on drafts of General Tests and General
Information related to Chromatography·········· 362
医薬品各条 アナストロゾール錠（案）及びビカルタミド錠（案）における溶出性の試験液量（1000mL）の規定について ·················································· 364
新規参考情報案「製剤に関連する添加剤の機能性関連特性について」について ··································· 365

国際調和

Pharmacopoeial Harmonization

１. Stage 2 案 (Official Inquiry Stage Draft)(1)試験法1)改正①PARTICULATE CONTAMINATION:
SUB-VISIBLE PARTICLES ······················· 366

Useful Information

第十八改正日本薬局方の制定等について ·············· 333
第十八改正日本薬局方の制定に伴う医薬品製造販売承認申請等の取扱いについて ····························· 352
日本薬局方の別名削除に伴う販売名のみを変更するものの取扱いについて ······································ 357
第十八改正日本薬局方第一追補の原案作成スケジュー
ルについて ·················································· 358
日本薬局方収載原案意見募集（令和 3 年 9 月分）に係るカラム情報の公開について ····························· 359
クロマトグラフィーに関連する一般試験法案及び参考
情報案について ············································ 360

海外薬局方情報

Foreign Pharmacopoeial Information

目視検査における薬局方の課題を解決する:可視的粒子試験の標準化と一貫性確保に向けて ················· 371

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 ················· 378
USP 標準品の取次販売のご案内 ······················ 388
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 ··································· 390～～～～～～～～～～～～～～～

Contents in English
Revision Drafts
Revision Drafts for First Supplement to JP 18
１. General Tests, Processes and Apparatus(1) Addition
2.28 Circular Dichroism Spectroscopy ······ 394
２. Official Monographs(1) Addition
Anastrozole Tablets································· 396
Bicalutamide Tablets ······························ 397(2) RevisionButyl Parahydroxybenzoate ····················· 399
Ethyl Parahydrxybenzoate ······················· 400
Magnesium Stearate ······························· 402
Methyl Parahydroxybenzoate ··················· 404
Propyl Parahydrxybenzoate······················ 405

３. Official Monographs－Crude Drugs(1) Revision
Burdock Fruit ········································ 407
Prepared Glycyrrhiza ······························ 407
４. General Information(1) Addition
Functionality-related
Characteristics
ofExcipients Relevant to Preparations〈G9-1-181〉···························································· 407
Drafts for General Tests and General Information
regarding Chromatography
１. General Tests, Processes and Apparatus(1) Addition
2.00 Chromatography ··························· 408(2) Revision
2.01 Liquid Chromatography ················· 419
2.02 Gas Chromatography ····················· 422

iii

２. General Information(1) Addition
Control Strategies and Change Control Concepts
at Each Stage of Chromatography Lifecycle(Change Control in Chromatography Lifecycle)〈G1-5-181〉 ········································· 424
Revision of the Description of Crude Drugs (theAddition of the Sentence, “Calculated on the Basis of
the Content obtained by qNMR”, to the Amount (MS)in the Assay) for listed Articles (OfficialMonographs))
Ginger ·················································· 427
Powdered Ginger ···································· 427
Goshuyuto Extract ································· 427
Hangekobokuto Extract ··························· 427
Shimbuto Extract ··································· 427
Mukoi-Daikenchuto Extract ····················· 427
Processed Ginger ···································· 427
Cornus Fruit·········································· 427
Goshajinkigan Extract ···························· 427
Hachimijiogan Extract ···························· 427
Drafts for First Supplement to JP18 regarding theMonographs Scheduled to be Deleted
１. Official Monographs
Nartograstim (Genetical Recombination) ··· 428
Nartograstim
forInjection(GeneticalRecombination) ······································ 428

Reference Standards
PMRJ Reference Standards Ordering Information
for Foreign Users ······································· 429

Useful Information
Briefing on drafts of General Tests and General
Information related to Chromatography ·········· 362

Pharmacopoeial Harmonization
１. Stage 2 案 (Official Inquiry Stage Draft)(1)Tests
1)Addition①PARTICULATE CONTAMINATION:
SUB-VISIBLE PARTICLES ························ 366

次号（30 巻 4 号）出版月：2021 年 12 月
Publishing Schedule (Vol.30, No.4): December 2021