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

Vol. 32 No. 4

December 2023

目

次Contents
改正案

Revision Drafts

第十八改正日本薬局方第二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
ステアリン酸マグネシウム ·························· 763
２. 医薬品各条(生薬等)(1) 既収載
ショウズク ··············································· 763
ニクズク ·················································· 763
第十八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（報告）１. 医薬品各条(化学薬品等)(1) 新収載
オキサリプラチン ······································ 764
オキサリプラチン注射液 ····························· 766(2) 既収載
クリンダマイシンリン酸エステル·················· 768
ブシ配合漢方処方エキスの総アルカロイド定量法の追加改定について（報告）牛車腎気丸エキス ······································ 769
真武湯エキス ············································ 769
八味地黄丸エキス ······································ 769
第十八改正日本薬局方第二追補に収載予定の改正案の見送り（報告）１. 一般試験法(1) 既収載
6.10 溶出試験法 ······································· 770
２. 医薬品各条（化学薬品等）(1) 既収載
コムギデンプン ········································· 770
コメデンプン ············································ 770
トウモロコシデンプン ································ 770
バレイショデンプン ··································· 770
第十九改正日本薬局方に収載予定の改正案(意見募集)
１. 参考情報(1) 既収載
固体又は粉体の密度〈G2-1-190〉 ····················· 771

第十九改正日本薬局方に収載予定の改正案(意見募集)
１. 一般試験法(1) 既収載
3.06 レーザー回折・散乱法による粒子径測定法······························································· 772
9.41 試薬・試液等 ···································· 776
２. 医薬品各条（化学薬品等）(1) 新収載
カモスタットメシル酸塩錠 ··························· 776
プランルカストカプセル ······························ 778
シロップ用プランルカスト ··························· 778(2) 既収載
プランルカスト水和物 ································· 779
プロピレングリコール ································· 780
３. 医薬品各条（生薬等）(1) 既収載
アカメガシワ ············································· 781
カシュウ ··················································· 781
キキョウ末 ················································ 781
ゴシツ ······················································ 781
チクセツニンジン ······································· 781
チクセツニンジン末 ···································· 781
リュウタン ················································ 782
第十九改正日本薬局方に収載予定の改正案(報告)１. 一般試験法(1) 既収載
4.05 微生物限度試験法 ······························ 782

薬局方関連通知など

Useful Information

日本薬局方収載原案意見募集（2023 年 11 月報告）に係るカラム情報の公開について ······················· 783
日本薬局方収載原案意見募集（2023 年 12 月 1 日分）に係るカラム情報の公開について ···················· 783
第十八改正日本薬局方第一追補正誤表の送付について（その１） ·················································· 785

ii

第十八改正日本薬局方正誤表の送付について（その２）································································· 786
第十八改正日本薬局方（英文版）正誤表の送付について（その３） ··············································· 787

日本薬局方技術情報
一般試験法における「はかり及び分銅」の改定と関連
新規参考情報について ··································· 791

Foreign Pharmacopoeial Information

吸入剤及び点鼻剤の in vitro 性能試験：USP 専門委員会の見解 ························································ 811

標準品のご案内Japanese Pharmacopoeial Technical Information

国際調和

海外薬局方情報

Reference Standards

日本薬局方等標準品の頒布のご案内 ················· 823
USP 標準品の取次販売のご案内 ······················ 833
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 ··································· 834

Pharmacopoeial Harmonization

１. Stage 2 案 (Official Inquiry Stage Draft)(1) 試験法1)改正① Particle Size Analysis by Laser Light
Diffraction (Rev.1) ····································· 793
２. 薬局方調 和国際会議調和合意文書 (HarmonizedDocument)(1) 試験法1)改正・訂正・表紙訂正① Microbial Enumeration Tests (Rev.1 Corr.2)······························································· 800

総目次

Cumulative ContentsVol. 32 総目次 ················································ 872～～～～～～～～～～～～～～～

Contents in English
Revision Drafts
Revision Drafts for Second Supplement to JP 18
１. Official Monographs(1) Revision
Magnesium Stearate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 840
２. Official Monographs－Crude Drugs(1) Revision
Cardamon ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 840
Nutmeg ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 840
Additional Revision of the Revision Drafts for SecondSupplement to JP 18
１. Official Monographs(1) Addition
Oxaliplatin ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 841
Oxaliplatin Injection ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 844(2) Revision
Clindamycin Phosphate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 846
Additional Revision of the Assay of total alkaloids forpreparations prescribed with Processed Aconite Root
Goshajinkigan Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 847
Hachimijiogan Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 847
Shimbuto Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 847

Cancel of Revision Drafts for the Second Supplement toJP18
１. General Rules for Preparations(1) Revision
6.10 Dissolution Testꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 848
２. Official Monographs(1) RevisionCorn Starchꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 848
Potato Starch ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 848
Rice Starch ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 848
Wheat Starch ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 848
Drafts for JP 19
１. General Tests, Processes and Apparatus(1) Revision
3.06 Laser Diffraction Measurement of Particle Sizeꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 849
4.05 Microbiological Examination of Non-sterile
Productsꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 854
9.41 Reagents, Test Solutions ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 854
２. Official Monographs(1) Addition
Camostat Mesilate Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 855
Pranlukast Capsules ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 856

iii

Pranlukast for Syrup ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 857(2) Revision
Pranlukast Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 858
Propylene Glycol ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 859
３. Official Monographs－Crude Drugs(1) Revision
Achyranthes Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 860
Japanese Gentian ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 860
Mallotus Bark ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 860
Panax Japonicus Rhizome ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 860
Powdered Panax Japonicus Rhizome ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 861
Powdered Platycodon Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 861
Polygonum Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 861
４. General Information(1) Revision
Solid and Particle Densities〈G2-1-190〉 ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 861

Pharmacopoeial Harmonization
１. Stage 2 (Official Inquiry Stage Draft)(1) Tests
1) Revision① Particle Size Analysis by Laser Light Diffraction(Rev.1) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 793
２. Harmonized Document(1) Tests
1) Revision ・ Correction ・ Correction of sign-offcoversheet① Microbial Enumeration Tests (Rev.1 Corr.2)
ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 800

Cumulative ContentsVol. 32 Cumulative Contents ································· 875

Reference Standards
PMRJ Reference Standards Ordering Information for
Foreign Users ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 863

次号（33 巻 1 号）出版月：2024 年 3 月
Publishing Schedule (Vol.33, No.1): March 2024