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

Vol. 24

No. 4

December 2015

目次Contents

改正案

Revision Drafts

第十七改正日本薬局方第一追補に収載予定の溶出性等に関する改正案（意見募集）
１. 医薬品各条（化学薬品等）(1) 新収載
アゾセミド錠 ············································ 721
メトトレキサート錠 ··································· 721
第十七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
メサラジン ··············································· 722
メサラジン徐放錠 ······································ 724(2) 既収載
エダラボン注射液 ······································ 725
スルタミシリントシル酸塩水和物·················· 727
２. 医薬品各条（生薬等）(1) 既収載
キキョウ ·················································· 728
サンシシ ·················································· 728
サンソウニン ············································ 728
タイソウ ·················································· 728
３. 参照紫外可視吸収スペクトル
スルタミシリントシル酸塩水和物·················· 729
メサラジン ··············································· 729
４. 参照赤外吸収スペクトル
メサラジン ··············································· 730
５. 参考情報(1) 新収載
医薬品の安定性試験の実施方法····················· 731

３．
「第十七改正日本薬局方原案作成要領(一部改正その2)案に関するご意見の募集について」に対して寄せられたご意見について ······································ 827
４．
「ICH Q3C(R6)：医薬品の残留溶媒ガイドライン(案)」に関する御意見・情報の募集について ·············· 829
５.日本薬局方収載医薬品に係る残留溶媒の管理等について··························································· 830
６.日本薬局方収載医薬品に係る残留溶媒の管理等に関する質疑応答集(Q&A)について(その 1) ············ 832
７．参考情報「医薬品の安定性試験の実施方法」(案)の趣旨等について ············································ 835

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・訂正①Uniformity of Dosage Units (Rev.2) ··········· 836(2)各条1)改正・訂正①Glucose Monohydrate/Anhydrous (Corr.1)·· 842②Isomalt(Corr.1) ······································ 843③Povidone (Rev.1，Corr.1) ························ 844④Wheat Starch(Rev.2, Corr.1) ···················· 846

海外薬局方情報

１．トピック（翻訳情報）(1) ゼラチンカプセル及びゼラチンコート錠の溶出試
験における酵素の使用 ···································· 847

標準品のご案内
薬局方関連通知など

Authority Announcements

１．医薬品の元素不純物ガイドラインについて ····· 734
２．第十七改正日本薬局方原案作成要領(一部改正その2)について ·················································· 735

Foreign Pharmacopoeial Information

Useful Information

日本薬局方等標準品の頒布のご案内 ················· 870
アメリカ薬局方標準品の取次販売のご案内 ········ 883
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 ··································· 885

ii

総目次

Cumulative Contents

Vol.24 総目次 ·················································· 929～～～～～～～～～～～～～～～

Contents in English

Revision Drafts
Revision Drafts on Dissolution for First Supplement to JP
17
１. Official Monographs(1) Addition
Azosemide Tablets ····································· 891
Methotrexate Tablets ··································· 891
Revision Drafts for First Supplement to JP 17
１. Official Monographs(1) Addition
Mesalazine ··············································· 892
Mesalazine Extended-release Tablets ················ 895(2) Revision
Edaravone Injection ···································· 896
Sultamicillin Tosilate Hydrate ························ 899
２. Official Monographs－Crude Drugs(1) Revision
Gardenia Fruit ··········································· 901
Jujube ····················································· 901
Jujube Seed ·············································· 901
Platycodon Root ········································ 901
３. Infrared Reference Spectra
Mesalazine ··············································· 901
４. Ultraviolet-visible Reference Spectra
Mesalazine ··············································· 902
Sultamicillin Tosilate Hydrate ························ 902
５. General Information(1) Addition
Stability Testing for Drug Substance and Product·· 903
Additional Revision of the Revision Drafts for JP 17
１. General Rules for Preparations ··························· 907

２. General Information(1) Addition
Basic requirements and terms for the packaging ofpharmaceutical products ······························· 908
Errata of the revision drafts for JP 17, published at
somewhere in the JP Forum
１. Official Monographs
Arsenical Paste ·········································· 913
２. Official Monograph－Crude drugs
Sweet Hydrangea Leaf ································· 913

Pharmacopoeial Harmonization
１．Harmonized Document(1)General Tests
1)Revision, Correction①Uniformity of Dosage Units (Rev.2) ················· 836(2)Monographs
1) Revision, Correction①Glucose Monohydrate/Anhydrous (Corr.1) ········· 842②Isomalt(Corr.1) ········································· 843③Povidone (Rev.1，Corr.1) ···························· 844④Wheat Starch(Rev.2, Corr.1) ························· 846

Useful Information
PMRJ Reference Standards Ordering Information for Foreign
Users··························································· 914

Cumulative Contents
Vol.24 Cumulative Contents ·································· 933

次号（25 巻 1 号）出版月：2016 年 3 月
Publishing Schedule (Vol.25, No.1): March 2016