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

Vol. 25

No. 4

December 2016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）
１. 医薬品各条（化学薬品等）(1) 既収載
アムホテリシン B 錠 ··································· 665
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. 参考情報(1) 既収載
粉体の細かさの表示法 ································ 666
アミノ酸分析法 ········································· 666
第十七改正日本薬局方における国際調和········· 667
第十七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
イルベサルタン錠 ······································ 672
インスリン アスパルト(遺伝子組換え)·········· 672(2) 既収載
バソプレシン注射液 ··································· 674
ホスホマイシンカルシウム水和物·················· 674
第十七改正日本薬局方第一追補に収載予定の国際調和試験法及び医薬品各条に関する改正案の追加改定（報告）１. 一般試験法(1) 既収載
6.02 製剤均一性試験法 ······························ 675
２. 医薬品各条（化学薬品等）(1) 新収載
精製ブドウ糖 ············································ 675
ブドウ糖水和物 ········································· 675(2) 既収載
低置換度ヒドロキシプロピルセルロース········· 675
ラウリル硫酸ナトリウム ····························· 675

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
クロルプロマジン塩酸塩・フェノバルビタール・
プロメタジン塩酸塩錠 ······························· 676
日本薬局方フォーラムの正誤について ···················· 676

薬局方関連通知など

Authority Announcements

日本薬局方原案の意見公募期間の延長について······ 677
第十八改正日本薬局方原案作成要領（案）に関するご意見の募集について ··································· 678
第十八改正日本薬局方作成基本方針について········· 774「第十八改正日本薬局方作成基本方針（案）に関する意見の募集について」に対して寄せられた御意見等について ·················································· 778
第十七改正日本薬局方英文版の公開について········· 780

海外薬局方情報

Foreign Pharmacopoeial Information

ラ ー ジ サ ン プ ル サ イ ズ (Large Sample Size) へ のUSP<905>含量均一性ゼロ許容基準の適用 ··········· 781
使用への適合性：決定ルール及び目標測定不確かさ································································· 788

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 ···················· 802
アメリカ薬局方標準品の取次販売のご案内············ 815
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 ································ 817

総目次

Cumulative Contents

Vol.25 総目次 ················································· 873～～～～～～～～～～～～～～～

ii

Contents in EnglishRevision Drafts
Revision Drafts for Second Supplement to JP 17
１. Official Monographs(1) Revision
Amphotericin B Tablets······························· 823
Revision Drafts for First Supplement to JP 17
１. General Tests, Processes and Apparatus(1) Addition
6.14 Uniformity of Delivered Dose for Inhalations························································ 823
6.15 Aerodynamic Particle Size Measurement forInhalations ··········································· 827
２. Official Monographs－Crude Drugs(1) Revision
Curcuma Rhizome ····································· 836
Euodia Fruit ············································ 837
Trichosanthes Root ···································· 837
Turmeric ················································ 837
Powdered Turmeric ···································· 837
３. General Information(1) Addition
Aerodynamic Assessment of Fine Particles forInhalations by Glass Impingers ··················· 837
Glass containers for pharmaceutical products······ 840
Guideline on impurities in drug substances andpreparations ········································· 842(2) Revision
Powder Fineness ······································· 843
Amino Acid Analysis ································· 844
International Harmonization Implemented in theJapanese Pharmacopoeia Seventeenth Edition························································ 845

Additional Revision of the Revision Drafts for First
Supplement to JP 17
１. Offiial Monographs(1) Addition
Insulin Aspart (Genetical Recombination) ·········· 851
Irbesartan Tablets ······································· 854(2) Revision
Fosfomycin Calcium Hydrate ························· 854
Vasopressin Injection ·································· 854
Additional Revision of the Revision Drafts Related toPharmacopoeial Harmonization for First Supplement toJP 17
１. General Tests, Processes and Apparatus(1) Revision
6.02 Uniformity of Dosage Units ·················· 855
２. Official Monographs(1) Addition
Glucose Hydrate ········································ 855
Purified Glucose ········································ 855(2) Revision
Low Substituted Hydroxypropylcellulose ··········· 855
Sodium Lauryl Sulfate ································· 855
Cancel of Revision Drafts for First Supplement to JP 17
１. Offiial Monographs(1) Addition
Chlorpromazine Hydrochloride･Phenobarbital･Promethazine Hydrochloride Tablets ············· 856
List of Errata for JP Forum································· 856

Useful Information
PMRJ Reference Standards Ordering Information
for Foreign Users ········································· 857

Cumulative Contents
Vol.25 Cumulative Contents ·································· 876

次号（26 巻 1 号）出版月：2017 年 3 月
Publishing Schedule (Vol.26, No.1): March 2017