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

Vol. 29

No. 1

March 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
3.01 かさ密度測定法 ·····································1
２. 医薬品各条（化学薬品等）(1) 新収載
オキシブチニン塩酸塩 ····································3(2) 既収載
ブトロピウム臭化物 ·······································4
ブロムヘキシン塩酸塩 ····································4dl－メントール ··············································5l－メントール ················································5３. 医薬品各条（生薬等）(1) 既収載
サンシシ ······················································5チョウジ ······················································5
チョウジ油 ···················································5４. 参照紫外可視吸収スペクトル
オキシブチニン塩酸塩 ····································6５. 参照赤外吸収スペクトル
オキシブチニン塩酸塩 ····································6６. 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·············7
粉体の流動性 ················································7
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 ········································· 10
２. 参考情報(1) 新収載
せん断セル法 ·············································· 10(2) 既収載
製薬用水の品質管理 ····································· 13

第十八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
2.46 残留溶媒 ··········································· 15
2.51 導電率測定法 ····································· 15
２. 医薬品各条（化学薬品等）(1) 既収載
セフォペラゾンナトリウム ···························· 16
既収載品目（医薬品各条）の基原の改正について（報告）カルメロースカルシウム ······························· 16
カルメロースナトリウム ······························· 16
クロスカルメロースナトリウム ······················ 16
第十八改正日本薬局方改正案の追加改定（報告）１. 通則 ·························································· 17
２. 一般試験法(1) 既収載
2.48 水分測定法(カールフィッシャー法) ·········· 17
第十八改正日本薬局方に収載予定の見送りについて（報告）１. 一般試験法(1) 既収載
2.58 粉末Ｘ線回折測定法 ···························· 20
２. 医薬品各条（化学薬品等）(1) 既収載
クロスカルメロースナトリウム ······················ 20
黄色ワセリン ·············································· 20
白色ワセリン ·············································· 20
３． 参照赤外吸収スペクトル
クロスカルメロースナトリウム ······················ 20
黄色ワセリン ·············································· 20
白色ワセリン ·············································· 20

薬局方関連通知など

Authority Announcements

日本薬局方収載原案意見募集（令和 2 年 3 月分）に係るカラム情報の公開について ······························ 21

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国際調和

Pharmacopoeial Harmonization

１.国際調和案(PDG Stage 2)(1) 試験法1)新規①日米欧三薬局方検討会議（PDG）における G-07
Elemental Impurities -Procedures 調和案（Stage 2）と日局一般試験法「2.66 元素不純物試験法」及び「2.66 元素不純物（案）」の関係並びに今後の予定について ·····················································22
Elemental Impurities -Procedures ··················23
元素不純物試験法（仮訳） ··························28
元素不純物試験法（日局独自記載反映） ········322)改正①Powder Flow ··········································· 37②Bulk Density ··········································· 43

海外薬局方情報

Foreign Pharmacopoeial Information

米国薬局方の分析手順のライフサイクルパラダイムを支援するための分析方法と分析手順の区別 ·········· 48
吸入剤の包装／送達システムのエラストマー材料 · 55

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 ··················· 61
USP 標準品の取次販売のご案内 ························ 70
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 ····································· 72～～～～～～～～～～～～～～～

Contents in English
Revision Drafts
Revision Drafts for First Supplement to JP 18
１. General Tests, Processes and Apparatus(1) Revision
3.01 Determination of Bulk Density ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 76
9.41 Reagents, Test Solutions ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 79
２. Official Monographs(1) Addition
Oxybutynin Hydrochlorideꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 79(2) Revision
Bromhexine Hydrochloride ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 80
Butropium Bromide ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 81
dl-Mentholꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 81
l-Menthol ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 81
３. Official Monographs－Crude Drugs(1) Revision
Clove ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 81
Clove Oil ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 81
Gardenia Fruit ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 82
４. Infrared Reference Spectra
Oxybutynin Hydrochlorideꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 82
５. Ultraviolet-visible Reference Spectra
Oxybutynin Hydrochlorideꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 83
６. General Information(1) Addition
Shear cell methods ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 83(2) Revision
On the Scientific Names of Crude Drugs listed in the JPꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 87
Powder Flowꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 87
Quality Control of Water for Pharmaceutical Use ꞏꞏꞏ 91
Drafts for JP 18
１. General Tests, Processes and Apparatus(1) Revision
2.46 Residual Solvents ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 94
2.51 Conductivity Measurement ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 95
２. Official Monographs(1) Revision
Cefoperazone Sodium ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 95
Revision of the origin/limits for listed articles (officialmonographs) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 96
Additional Revision of the Revision Drafts for JP 18
１. General Notice ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 96
２. General Tests, Processes and Apparatus(1) Revision
2.48 Water Determination (Karl Fischer Method) 96
Cancel of Revision Drafts for JP18
１. General Tests, Processes and Apparatus(1) Revision
2.58 X-Ray Powder Diffraction Method ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 101
２. Official Monographs(1) Revision
Croscarmellose Sodium ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 101
White Petrolatum ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 101
Yellow Petrolatumꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 101

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３. Infrared Reference Spectra
Croscarmellose Sodium ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 101White Petrolatum ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 101
Yellow Petrolatumꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 101

Useful Information
PMRJ Reference Standards Ordering Information for
Foreign Users ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 102

Pharmacopoeial Harmonization
１.PDG Stage 2(1) General Tests
1)Addition①Elemental Impurities -Procedures ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 232)Revision①Powder Flow ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 37②Bulk Density ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 43

次号（29 巻 2 号）出版月：2020 年 6 月
Publishing Schedule (Vol.29, No.2): June 2020