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

Vol. 26

No. 1

March 2017目

次Contents

改正案

Revision Drafts

第十七改正日本薬局方第二追補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 ···········································1
第十七改正日本薬局方第二追補に収載予定の改正案（意見募集）その２
１. 医薬品各条（生薬等）(1) 既収載
ユーカリ油 ···················································3
第十七改正日本薬局方第一追補に収載予定の改正案(報告)１. 一般試験法(1) 既収載
9.41 試薬・試液 ···········································4
第十七改正日本薬局方第一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
アカルボース ················································5
アカルボース錠 ·············································5
２. 参照赤外吸収スペクトル
アカルボース ················································5

薬局方関連通知など

Authority Announcements

第十七改正日本薬局方収載標準品の供給開始時期について(その２) ····················································6
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 ·············································7
第十八改正日本薬局方原案作成要領について ·········· 25

国際調和Pharmacopoeial Harmonization

１. 日米欧三薬局方調和合意文書表紙（Sign-off Cover Sheet of Harmonized Document）(1)試験法1)新規①Color (Instrumental method) ···················· 1222)改正・訂正・表紙改正①Amino Acid Determination (Rev. 1) ··········· 123②Uniformity of Content/Mass (Rev. 2, Corr. 1)···························································· 124
(2)各条
1)新規
①Hydroxyethylcellulose ····························· 1252)改正・訂正・表紙改正 ······························· 126①Croscarmellose Sodium (Revision of Sign-off
Cover Sheet) ·········································· 126②Cellulose Acetate (Rev. 3)························· 128③Cellulose, Microcrystalline (Rev. 1, Revisionof Sign-off Cover Sheet) ··························· 129④ Cellulose, Powdered (Rev. 1, Revision ofSign-off Cover Sheet) ······························· 131⑤Ethylcellulose (Rev. 2) ····························· 133⑥Gelatin, Gelling grade (Corr. 3) ················· 134⑦Gelatin, Non-gelling grade (Corr. 3) ··········· 136⑧Hydroxypropylcellulose, Low Substituted(Corr. 2) ················································ 138⑨ Hypromellose (Rev. 1, Revision of Sign-off
Cover Sheet) ·········································· 139⑩Isomalt (Corr. 1) ····································· 140⑪Lactose, Anhydrous (Rev. 4, Revision of Signoff Cover Sheet) ······································ 141⑫Polysorbate 80 (Corr, 2, Revision of Sign-off
Cover Sheet) ·········································· 143⑬Polysorbate 80 (Corr. 3) ··························· 144⑭Saccharin Sodium (Rev. 2, Corr. 1) ············ 145

ii⑮Saccharin Sodium (Rev. 2, Revision of Signoff Cover Sheet) ······································ 146⑯Sodium Chloride (Rev. 3, Corr. 1) ·············· 147

海外薬局方情報

Foreign Pharmacopoeial Information

新しい USP 一般情報章“<1062>錠剤の圧縮特性評価”の提案······················································ 148

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 ················· 168
アメリカ薬局方標準品の取次販売のご案内 ········ 181
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 ··································· 183

新しい USP 一般情報章“<1062>錠剤の圧縮特性評価”の提案に関するコメントに対する USP の回答 ··· 160
USP-NF より包装及び保存に関する項を削除すること，及び容器性能試験より密閉規格を削除することの妥当性について ······································ 164～～～～～～～～～～～～～～～

Contents in English

Revision Drafts

Authority Announcements

Revision Drafts for Second Supplement to JP 17
１. General Tests, Processes and Apparatus(1) Revision
9.41 Reagents, Test solution ························ 189
２. Official Monographs－Crude Drugs(1) Revision
Eucalyptus Oil ··········································· 190
Revision Drafts for First Supplement to JP 17
１. General Tests, Processes and Apparatus(1) Revision
9.41 Reagents, Test solution ························ 191
Cancel of Revision Drafts for First Supplement to JP 17
１. Offiial Monographs(1) Addition
Acarbose ·················································· 192
Acarbose Tablets ········································· 192
２. Infrared Reference Spectra
Acarbose ·················································· 192

Information about Columns for Japanese Pharmacopoeia Draft
Monographs (Chemical Drug) ····························· 193
Disclosure of Information about Columns for JapanesePharmacopoeia Draft Monographs ························ 194
Disclosure of Information about Columns for JapanesePharmacopoeia Draft Monographs for Crude Drugs ···· 195

Useful Information
PMRJ Reference Standards Ordering Information for Foreign
Users··························································· 213

次号（26 巻 2 号）出版月：2017 年 6 月
Publishing Schedule (Vol.26, No.2): June 2017