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

Vol. 28

No. 1

March 2019目

次Contents
改正案

国際調和

Revision Drafts

第十八改正日本薬局方に収載予定の改正案（意見募集）
１. 一般試験法(1) 既収載
9.41 試薬・試液 ···········································1
第十八改正日本薬局方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
カリジノゲナーゼ ··········································2
テセロイキン(遺伝子組換え) ····························2
ナルトグラスチム(遺伝子組換え)·······················3
２. 医薬品各条（生薬等）(1) 既収載
クジン ·························································3
クジン末 ······················································3チョウジ ······················································4
チョウジ末 ···················································4チョウトウコウ ·············································4Pharmacopoeial Harmonization

１. Stage 2 案(Draft for Official Inquiry)(1) 各条1)新規①Petrolatum ············································· 12
黄色ワセリン ··········································· 15②White Petrolatum ···································· 18
白色ワセリン ··········································· 212)改正①Sodium Lauryl Sulfate ····························· 24
ラウリル硫酸ナトリウム ···························· 25
２. 日米欧三薬局方調和合意文書表紙（Sign-off CoverSheet of Harmonized Document）(1) 試験法1)改正・訂正・表紙改正①Capillary Electrophoresis (Corr.3) ·············· 28

海外薬局方情報

Foreign Pharmacopoeial Information

各条作成のための技術ガイド (EP) ···················· 30
医薬品原材料，中間体，及び製剤の物理的安定性を評価及び管理するためのガイドライン························ 38

日本薬局方技術情報
Japanese Pharmacopoeial Technical Information

2.26 ラマンスペクトル測定法について····················56.17 タンパク質医薬品注射剤の不溶性微粒子試験法について ·························································· 10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 ··················· 48
アメリカ薬局方標準品の取次販売のご案内 ·········· 66
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 ····································· 68～～～～～～～～～～～～～～～

[日局改正案]

ii

Contents in English

Revision Drafts

Pharmacopoeial Harmonization

Drafts for JP 18
１. General Tests, Processes and Apparatus(1) Revision
9.41 Reagents, Test Solutions ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 73
２. Official Monographs(1) Revision
Kallidinogenaseꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 73
Nartograstim (Genetical Recombination) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 74
Teceleukin (Genetical Recombination)ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 74
３. Official Monographs－Crude Drugs(1) Revision
Clove ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 75
Powdered Clove ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 75
Sophora Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 76
Powdered Sophora Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 76
Uncaria Hook ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 76

１. PDG Stage 2 (Draft for Official Inquiry)(1) Monographs
1)Addition①Petrolatum ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 12②White Petrolatum ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 182)Revision①Sodium Lauryl Sulfate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 24
２. Sign-off Cover Sheet of Harmonized Document(1) General Tests
1)Revision・Correction・Revision of Cover Sheet①Capillary Electrophoresis (Corr.3) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 28

Useful Information
PMRJ Reference Standards Ordering Information for
Foreign Users ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 77

次号（28 巻 2 号）出版月：2019 年 6 月
Publishing Schedule (Vol.28, No.2): June 2019