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

Vol. 29

No. 2June 2020

目次Contents
改正案

Revision Drafts

第十八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. 一般試験法(1) 新収載
3.07 動的光散乱法による液体中の粒子径測定法···························································· 111
２. 医薬品各条（化学薬品等）(1) 新収載
アナストロゾール ······································ 113(2) 既収載
ホルモテロールフマル酸塩水和物·················· 114
３. 参照紫外可視吸収スペクトル
アナストロゾール ······································ 117
４. 参照赤外吸収スペクトル
アナストロゾール ······································ 117
第十八改正日本薬局方に収載予定の改正案（報告）１. 医薬品各条（化学薬品等）(1) 既収載
バソプレシン注射液 ··································· 118
第十八改正日本薬局方改正案の追加改定（報告）１. 医薬品各条（化学薬品等）(1) 新収載
エリブリンメシル酸塩 ································ 119
ドルゾラミド塩酸塩・チモロールマレイン酸塩点
眼液 ······················································ 123
ロスバスタチンカルシウム ·························· 125
ロフラゼプ酸エチル ··································· 128
ロフラゼプ酸エチル錠 ································ 129
既収載品目(医薬品各条(化学薬品等))の強熱残分規格の改正について（報告）
パロキセチン塩酸塩水和物 ·························· 130
レボフロキサシン水和物 ····························· 130
既収載品目（医薬品各条(生薬等)）の確認試験の改正について（報告）サンソウニン ············································ 131
センキュウ ··············································· 131
センキュウ末 ············································ 131

ゼンコ ······················································ 131
ボクソク ··················································· 131
第十八改正日本薬局方で改正予定の見送りについて（報告）１. 医薬品各条（生薬等）(1) 既収載
センコツ ··················································· 131

薬局方関連通知など

Useful Information「第十八改正日本薬局方における医薬品各条に掲げた日本名別名の削除について（報告）」の一部訂正について ··························································· 132
日本薬局方収載原案意見募集（令和 2 年 6 月分）に係るカラム情報の公開について ····························· 133
第十七改正日本薬局方正誤表の送付について（その５）································································· 134
第十七改正日本薬局方第一追補正誤表の送付について（その 1） ··················································· 135
第十七改正日本薬局方第二追補正誤表の送付について（その 1） ··················································· 136
第十七改正日本薬局方（英文版）正誤表の送付について（その４） ·················································· 137
第十七改正日本薬局方第一追補（英文版）正誤表の送付について（その１） ······································ 138
第十七改正日本薬局方第二追補（英文版）正誤表の送付について（その１） ······································ 139

国際調和

Pharmacopoeial Harmonization

１. Stage 2 案 (Official Inquiry Stage Draft)(1) 試験法1)新規① Particle size analysis by dynamic lightscattering ·············································· 140

海外薬局方情報

Foreign Pharmacopoeial Information

温度逸脱の評価を支援するための平均キネティック温度の使用：適切及び不適切な適用·························· 143

ii

標準品のご案内

Reference Standards

日本薬局方等標準品の頒布のご案内·················· 157
USP 標準品の取次販売のご案内 ······················ 166

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 ··································· 168～～～～～～～～～～～～～～～

Contents in English
Revision Drafts
Revision Drafts for First Supplement to JP 18
１. General Tests, Processes and Apparatus(1) Addition
3.07 Particle size analysis by dynamic light scattering···························································· 171
２. Official Monographs(1) Addition
Anastrozole·············································· 171(2) Revision
Formoterol Fumarate Hydrate ························ 173
３. Infrared Reference Spectra
Anastrozole·············································· 176
４. Ultraviolet-visible Reference Spectra
Anastrozole·············································· 176
Drafts for JP 18
１. Official Monographs(1) Revision
Vasopressin Injection ·································· 177
Additional Revision of the Revision Drafts for JP 18
１. Official Monographs(1) Addition
Dorzolamide Hydrochloride and Timolol Maleate
Ophthalmic Solution ··································· 178
Eribulin Mesilate ······································· 181
Ethyl Loflazepate ······································· 185
Ethyl Loflazepate Tablets ····························· 187
Rosuvastatin Calcium ·································· 189
Revision of the Residue on ignition for listed articles(official monographs)

Paroxetine Hydrochloride Hydrate ················ 192
Levofloxacin Fine Granules ·························· 192
Revision of the identification of crude drugs for listed
articles (official monographs)
Cnidium Rhizome······································ 193
Powdered Cnidium Rhizome ························· 193
Jujube Seed ············································· 193
Peucedanum Root ······································ 193
Quercus Bark ··········································· 193
Cancel of Revision Drafts for JP18
１. Official Monographs－Crude drugs(1) Revision
Nuphar Rhizome ······································· 193

Reference Standards
PMRJ Reference Standards Ordering Information
for Foreign Users ······································ 194

Useful Information
JP17 table of errata ········································ 137
Supplemetnt I to JP17 table of errata ················ 138
Supplemetnt II to JP17 table of errata ··············· 139

Pharmacopoeial Harmonization
１.PDG Stage 2(1) General Tests
1)Addition① Particle size analysis by dynamic lightscattering ················································ 140

次号（29 巻 3 号）出版月：2020 年 9 月
Publishing Schedule (Vol.29, No.3): September 2020