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

Vol. 25

No. 1

March 2016

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改正案（意見募集）
１. 製剤総則 ··················································· 1
２. 一般試験法(1) 新収載
3.06 レーザー回折・散乱法による粒子径測定法···························································· 1
３. 医薬品各条（化学薬品等）(1) 新収載
ゾニサミド ················································ 5
パズフロキサシンメシル酸塩························· 6
ペントバルビタールカルシウム錠··················· 7
レボホリナートカルシウム水和物··················· 8(2) 既収載
エパルレスタット ······································· 9
セフチゾキシムナトリウム ··························· 9
バソプレシン注射液 ··································· 10
ヒドロコルチゾン酪酸エステル····················· 12
ペントバルビタールカルシウム····················· 13
ポリミキシン B 硫酸塩 ································ 13
４. 医薬品各条（生薬等）(1) 既収載
インチンコウ ············································ 13
５. 参照紫外可視吸収スペクトル
ゾニサミド ··············································· 14
パズフロキサシンメシル酸塩························ 14
レボホリナートカルシウム水和物·················· 14
６. 参照赤外吸収スペクトル
ゾニサミド ··············································· 15
パズフロキサシンメシル酸塩························ 15
レボホリナートカルシウム水和物·················· 16
７. 参考情報(1) 新収載
酵素免疫測定法 ········································· 17

固形製剤のブリスター包装の水蒸気透過性試験法··························································· 19(2) 削除レーザー回折法による粒子径測定法 ·············· 20

薬局方関連通知など

Authority Announcements

１．第十七改正日本薬局方英文版原案作成要項 ····· 21
２．カラム情報の開示（医薬品各条 生薬等）について ······························································ 85

国際調和Pharmacopoeial Harmonization

１．Stage 4 案(Official Inquiry Stage Draft)(1)試験法1)新規① Instrumental Measurement of Coloration of
Liquids ··············································· 104
溶液の色の機器測定法 ···························· 108②Conductivity of Solutions ······················ 111
溶液の導電率測定法 ······························· 114

海外薬局方情報

Foreign Pharmacopoeial Information

１．トピック（翻訳情報）(1) USP <905>含量均一性試験の無差別領域の評価···························································· 117(2) バイオ医薬品保存時間試験の分析対象物としてのエンドトキシン ································· 127

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 ··············· 137
アメリカ薬局方標準品の取次販売のご案内 ······ 150
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 ··························· 152

ii～～～～～～～～～～～～～～～

Contents in EnglishRevision Drafts
Revision Drafts for First Supplement to JP 17
１. General Rules for Preparations ··························· 157
２. Official Monographs(1) Addition
Calcium Levofolinate Hydrate ························ 157
Pazufloxacin Mesilate ·································· 159
Pentobarbital Calcium Tablets ························ 161
Zonisamide ·············································· 162(2) Revision
Ceftizoxime Sodium ···································· 163
Epalrestat ················································ 164
Hydrocortisone Butyrate ······························· 164
Pentobarbital Calcium ·································· 165
Polymixin B Sulfate ···································· 165
Vasopressin Injection ·································· 166
３. Official Monographs－Crude Drugs(1) Revision
Artemisia Capillaris Flower ··························· 169
４. Infrared Reference Spectra
Calcium Levofolinate Hydrate ························ 169
Pazufloxacin Mesilate ·································· 170
Zonisamide ·············································· 170
５. Ultraviolet-visible Reference Spectra

Calcium Levofolinate Hydrate ························ 171
Pazufloxacin Mesilate ·································· 171
Zonisamide ·············································· 171
Drafts for JP 17
１. General Rules for Preparations ··························· 172
Additional Revision of the Revision Drafts for JP 17
１. General Tests, Process and Apparatus(1) Addition
6.13 Release Test for Preparations for Cutaneous
Application ·············································· 174

Pharmacopoeial Harmonization
１．Official Inquiry Stage Draft(1) General Tests
1)Addition① Instrumental Measurement of Coloration of Liquids···························································· 104②Conductivity of Solutions ····························· 111

Useful Information
PMRJ Reference Standards Ordering Information for Foreign
Users··························································· 175

次号（25 巻 2 号）出版月：2016 年 6 月
Publishing Schedule (Vol.25, No.2): June 2016