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

Vol. 30

No. 1

March 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. 医薬品各条（化学薬品等）(1) 新収載
ブデソニド ···················································1(2) 既収載
サルポグレラート塩酸塩細粒····························3
２. 医薬品各条（生薬等）(1) 新収載
柴胡桂枝乾姜湯エキス ····································3
３. 参照紫外可視吸光スペクトル
ブデソニド ···················································6
４. 参照赤外吸光スペクトル
ブデソニド ···················································6
既収載品目（医薬品各条(生薬等)）の生薬の性状の改正について（意見募集）
インチンコウ ················································7
ウコン ·························································7
ウワウルシ ···················································7
ガイヨウ ······················································7
シャゼンソウ ················································7
センナ ·························································8
ヤクモソウ ···················································8
第十八改正日本薬局方第一追補に収載予定の追加改定（報告）１. 一般試験法(1) 既収載
2.58 粉末Ｘ線回折測定法 ·······························8
第十八改正日本薬局方第一追補収載予定各条（医薬品各条）の その他の項における類縁物質化学名の変更について（報告）アナストロゾール ············································ 12
オキシブチニン塩酸塩 ···································· 13
テモゾロミド ·················································· 13
テモゾロミドカプセル ······································· 13
注射用テモゾロミド ········································· 13
ホルモテロールフマル酸塩水和物 ······················ 13

薬局方関連通知など

Useful Information

第十八改正日本薬局方原案作成要領（一部改正 その 2）について ······················································ 14
日本薬局方収載原案意見募集（令和 3 年 3 月分）に係るカラム情報の公開について ····························· 125

国際調和

Pharmacopoeial Harmonization

１ ． 日 米 欧 三 薬 局 方 調 和 合 意 文 書 (HarmonizedDocument)(1) 試験法1)改正①X-Ray Powder Diffraction(XRPD)(Rev.1) ···· 126(2)各条1)改正・訂正・表紙改正①Crosscarmellose Sodium (Rev.1)················ 139②Benzyl Alcohol (Rev.2 Corr.2) ··················· 144③Butyl Paraben (Rev.1, Corr.1) ··················· 152④Etyl Paraben (Rev.1, Corr.2) ····················· 157⑤Metyl Paraben (Rev.1, Corr.2) ·················· 162⑥Propyl Paraben (Rev.1, Corr.2) ················· 166⑦Sodium Chloride (Rev.3, Corr.2) ················ 171⑧Wheat Starch (Rev.3, Corr.1) ···················· 176⑨Magnesium Stearate (Correction of the sign-offcover sheet) ·············································· 182⑩Polysorbate 80 (Correction 2 of the sign-off coversheet)······················································· 184

海外薬局方情報

Foreign Pharmacopoeial Information

5.26. 局方試験法の実施(EP) ····························· 186<1225>公定法のバリデーション ························ 188<1226>公定法の検証······································· 193

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 ·················· 195
USP 標準品の取次販売のご案内 ······················· 204
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 ···································· 206

ii～～～～～～～～～～～～～～～

Contents in English
Revision Drafts

Reference Standards

Revision Drafts for First Supplement to JP 18
１. Official Monographs(1) Addition
Budesonide ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 209(2) Revision
Sarpogrelate Hydrochloride Fine Granules ꞏꞏꞏꞏꞏꞏꞏꞏꞏ 211
２. Official Monographs－Crude Drugs(1) Addition
Saikokeishikankyoto Extractꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 212
３. Infrared Reference Spectra
Budesonide ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 216
４. Ultraviolet-visible Reference Spectra
Budesonide ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 216
Revision of the description of crude drugs for listed
articles (official monographs)
Artemisia Leaf ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 217
Artemisia Capillaris Flower ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 217
Bearberry Leaf ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 217
Leonurus Herb ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 217
Plantago Herb ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 217
Senna Leaf ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 217
Turmeric ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 217

PMRJ Reference Standards Ordering Information forForeign Users ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 218

Pharmacopoeial Harmonization
１． Harmonized Document(1) General Tests
1) Revision・Correction・Revision of Cover Sheet①X-Ray Powder Diffraction(XRPD)(Rev.1) ꞏꞏꞏꞏꞏꞏꞏꞏꞏ 126(2)Monographs
1) Revision・Correction・Revision of Cover Sheet①Crosscarmellose Sodium (Rev.1) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 139②Benzyl Alcohol (Rev.2 Corr.2) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 144③Butyl Paraben (Rev.1, Corr.1) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 152④Etyl Paraben (Rev.1, Corr.2) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 157⑤Metyl Paraben (Rev.1, Corr.2) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 162⑥Propyl Paraben (Rev.1, Corr.2) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 166⑦Sodium Chloride (Rev.3, Corr.2) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 171⑧Wheat Starch (Rev.3, Corr.1) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 176⑨Magnesium Stearate (Correction of the sign-off coversheet) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 182⑩ Polysorbate 80 (Correction 2 of the sign-off coversheet) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 184

次号（30 巻 2 号）出版月：2021 年 6 月
Publishing Schedule (Vol.30, No.2): June 2021