No. 2

日本薬局方フォーラム
Japanese Pharmacopoeial Forum
Vol. 21
No. 2
June 2012
目
次
Contents
改正案 Revision Drafts
第十六改正日本薬局方第二追補に収載予定の溶出性に
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
オロパタジン塩酸塩錠 ································· 275
ピタバスタチンカルシウム錠 ························ 275
フルコナゾールカプセル ······························ 276
ベポタスチンベシル酸塩錠 ··························· 276
メキタジン錠·············································· 277
第十六改正日本薬局方第二追補に収載予定の改正案(意
見募集)
1. 製剤総則 ···················································· 278
2. 一般試験法
(1) 既収載
1.11 ヒ素試験法········································ 278
9.22 標準液 ·············································· 278
3. 医薬品各条(化学薬品等)
(1) 新収載
オロパタジン塩酸塩 ···································· 279
オロパタジン塩酸塩錠 ································· 279
(2) 既収載
アルプロスタジル アルファデクス ··············· 281
(3) 既収載(細粒剤の粒度の項の規定削除)
イルソグラジンマレイン酸塩細粒 ·················· 281
エチゾラム細粒 ·········································· 281
サルポグレラート塩酸塩細粒 ························ 281
乾燥水酸化アルミニウムゲル細粒 ·················· 281
セファクロル細粒 ······································· 281
セフカペン ピボキシル塩酸塩細粒 ··············· 281
セフジトレン ピボキシル細粒 ····················· 281
セフジニル細粒 ·········································· 281
セフテラム ピボキシル細粒 ························ 281
沈降炭酸カルシウム細粒 ······························ 281
ドネペジル塩酸塩細粒 ································· 281
ドロキシドパ細粒 ······································· 281
トロキシピド細粒 ······································· 281
ハロペリドール細粒 ···································· 281
プラバスタチンナトリウム細粒 ····················· 281
プロブコール細粒 ······································· 281
リスペリドン細粒 ······································· 281
4. 医薬品各条(生薬等)
(1) 既収載
アカメガシワ ············································· 281
キクカ······················································· 281
コウベイ···················································· 282
サンソウニン ············································· 282
チョウジ油 ················································ 282
ハッカ油···················································· 282
リュウタン ················································ 282
5. 参照紫外可視吸収スペクトル
オロパタジン塩酸塩 ···································· 283
6. 参照赤外吸収スペクトル
オロパタジン塩酸塩 ···································· 283
第十六改正日本薬局方第一追補改正案の追加改定(報
告)
1. 医薬品各条(化学薬品等)
(1) 新収載
クエチアピンフマル酸塩 ······························ 284
クエチアピンフマル酸塩細粒 ························ 284
バルサルタン ············································· 284
ii
薬局方関連通知など Authority Announcements
【英文版】第十七改正日本薬局方原案作成要領
Guideline for drafting The Japanese
Pharmacopoeia, Seventeenth Edition ··········· 349
国際調和 International Harmonization
1. Stage 4 案(Official Inquiry Stage Draft)
(1) 改正
①Ethylcellulose ········································ 285
エチルセルロース ···································· 289
海外薬局方情報 Foreign Pharmacopoeial Information
1. トピック(翻訳情報)
テストキット類を用いた分析 (Assays):品質管理の
場での適用 ·················································292
USP <1211>薬局方品の滅菌法及び無菌性保証に対す
る改正計画の概要········································300
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 ··················303
アメリカ薬局方標準品の取次販売のご案内 ·········314
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 ·································316
~~~~~~~~~~~~~~~
Contents in English
Revision Drafts
Revision Drafts on Dissolution for Second Supplement to
JP 16
1. Official Monographs
(1) Addition
Bepotastine Besilate Tablets ·························· 322
Fluconazole Capsules ·································· 323
Mequitazine Tablets ···································· 323
Pitavastatin Calcium Tablets ·························· 324
Revision Drafts for Second Supplement to JP 16
1. General Rules for Preparations ··························· 325
2. General Tests, Process and Apparatus
(1) Revision
1.11 Arsenic Limit Test ····························· 325
9.22 Standard Solutions ····························· 325
3. Official Monographs
(1) Addition
Olopatadine Hydrochloride ··························· 326
Olopatadine Hydrochloride Tablets ················· 327
(2) Revision
Alprostadil Alfadex ···································· 328
(3) Revision(Delete the Particle size of the following
monographs)
Dried Aluminum Hydroxide Gel Fine Granules ··· 329
Precipitated Calcium Carbonate Fine Granules ···· 329
Cefaclor Fine Granules ································ 329
Cefcapene Pivoxil Hydrochloride Fine Granules ·· 329
Cefdinir Fine Granules································· 329
Cefditoren Pivoxil Fine Granules ···················· 329
Cefteram Pivoxil Fine Granules ······················ 329
Donepezil Hydrochloride Fine Granules ············ 329
Droxidopa Fine Granules ······························ 329
Etizolam Fine Granules ·································329
Haloperidol Fine Granules ·····························330
Irsogladine Maleate Fine Granules ···················330
Pravastatin Sodium Fine Granules ····················330
Probucol Fine Granules ·································330
Risperidone Fine Granules ·····························330
Sarpogrelate Hydrochloride Fine Granules ··········330
Troxipide Fine Granules ································330
4. Official Monographs-Crude Drugs
(1) Revision
Brown Rice ···············································330
Chrysanthemum Flower ································330
Clove Oil··················································331
Japanese Gentian ········································331
Jujube Seed ···············································331
Mallotus Bark ············································331
Mentha Oil················································331
5. Infrared Reference Spectra
Olopatadine Hydrochloride ····························332
6. Ultraviolet-visible Reference Spectra
Olopatadine Hydrochloride ····························332
Revision Drafts for First Supplement to JP 16
1. General Rules for Preparations····························333
2. General Information
(1) Revision
G9 Others
International Harmonization Implemented in the
Japanese Pharmacopoeia Sixteenth Edition ·········334
Additional Revision of the Revision Drafts for First
Supplement to JP 16
1. Official Monographs
iii
(1) Addition
Quetiapine Fumarate ··································· 344
Quetiapine Fumarate Fine Granules ················· 344
Valsartan ················································· 344
2. Infrared Reference Spectra
Calcium Pantothenate ·································· 345
Revision Drafts for JP 16
Reagents, Test Solutions and Monographs in JP being
planned to be partially revised
1. General Tests, Process and Apparatus
(1) Revision
9.41 Reagents, Test Solutions ······················ 346
2. Official Monographs
(1) Revision
Atorvastatin Calcium Hydrate ························ 347
Candesartan Cilexetil ··································· 347
Donepezil Hydrochloride ······························ 347
Fexofenadine Hydrochloride ·························· 348
Nateglinide ··············································· 348
Rabeprazole Sodium···································· 348
Sarpogrelate Hydrochloride ··························· 348
Authority Announcements
Guideline for drafting The Japanese Pharmacopoeia,
Seventeenth Edition ····································· 349
International Harmonization
1. Official Inquiry Stage Draft
(1) Revision
①Ethylcellulose ········································· 285
Useful Information
PMRJ Reference Standards Ordering Information
for Foreign Users ········································· 433
次号(21 巻 3 号)出版月:2012 年 9 月
Publishing Schedule (Vol.21, No.3): September 2012