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

Vol. 28

No. 2June 2019

目次Contents
改正案

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
5.01 生薬試験法 ········································· 95
9.41 試薬・試液 ········································· 95
２. 参考情報(1) 新収載
バイオテクノロジー応用医薬品(バイオ医薬品)の品質確保の基本的考え方 ····························· 96
微生物試験法に用いる培地及び微生物株の管理 ·· 99
錠剤硬度測定法 ········································· 101
無菌医薬品包装の完全性評価························ 102
無菌医薬品包装の漏れ試験法························ 104(2) 既収載
キャピラリー電気泳動法 ····························· 107
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) 新収載
コポビドン ··············································· 112
テルミサルタン・アムロジピンベシル酸塩錠 ··· 114
トリアゾラム ············································ 116(2) 既収載
ヒト下垂体性性腺刺激ホルモン····················· 118
ゼラチン ·················································· 120
精製セラック ············································ 122
白色セラック ············································ 122
コムギデンプン ········································· 122
ラウロマクロゴール ··································· 123
２. 医薬品各条（生薬等）(1) 新収載
温清飲エキス ············································ 123
白虎加人参湯エキス ··································· 125(2) 既収載
センコツ ·················································· 128
センソ ····················································· 128
ソヨウ ····················································· 129

３. 参照紫外可視吸収スペクトルトリアゾラム ············································· 130
４. 参照赤外吸収スペクトル
コポビドン ················································ 130
トリアゾラム ············································· 131
５．参考情報(1) 既収載
日本薬局方収載生薬の学名表記について ········· 131
既収載品目（医薬品各条(生薬等)）の生薬の性状（におい及び味） の改正について（意見募集）
カッコン ··················································· 132
カロコン ··················································· 132
シャゼンシ ················································ 132
ビャクゴウ ················································ 132
ボウコン ··················································· 132
キョウカツ ················································ 132
クコシ ······················································ 132
サンシュユ ················································ 132
ショウズク ················································ 132
チョレイ ··················································· 132
チョレイ末 ················································ 132
第十八改正日本薬局方に収載予定の改正案の追加改正（報告）
１. 通則 ························································· 132

薬局方関連通知など

Authority Announcements

第十七改正日本薬局方正誤表の送付について（その４）································································· 133
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３） ·················································· 134参考情報「無菌医薬品包装の完全性評価」及び「無菌医薬品包装の漏れ試験法」の収載案の趣旨について································································· 135
日本薬局方収載原案意見募集（令和元年 6 月分）に係るカラム情報の公開について ····························· 136

ii

海外薬局方情報 Foreign Pharmacopoeial Information
非経口製剤の in vitro 溶出試験法························ 137
USP-NF の測色法の現代化 ································ 143

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 ················· 154
アメリカ薬局方標準品の取次販売のご案内 ········ 168
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 ··································· 169～～～～～～～～～～～～～～～

Contents in English
Revision Drafts
Drafts for JP 18
１. General Tests, Processes and Apparatus(1) Revision
5.01 Crude Drugs Testꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 173
9.41 Reagents, Test Solutions ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 173
２. Official Monographs(1) Addition
Copovidone ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 174
Telmisartan and Amlodipine Besilate Tablets ꞏꞏꞏꞏꞏꞏ 177
Triazolam ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 180(2) RevisionGelatin ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 182
Human Menopausal Gonadotrophin ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 185Lauromacrogol ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 188
Purified Shellac ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 188
White Shellac ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 188
Wheat Starch ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 188
３. Official Monographs－Crude Drugs(1) Addition
Byakkokaninjinto Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 189
Unseiin Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 193(2) Revision
Nuphar Rhizomeꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 195
Perilla Herb ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 196
Toad Cake ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 197
４. Infrared Reference Spectra
Copovidone ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 198
Triazolam ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 198

５. Ultraviolet-visible Reference Spectra
Triazolam ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 199
６. General Information(1) Addition
A basic concept of the quality assurance on
biotechnological products (biopharmaceuticals) ꞏꞏꞏꞏ 199
Control of Culture Media and Strains ofMicroorganisms Used for Microbial Test Methodsꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 204
Leak Tests for Packaging of Sterile Products ꞏꞏꞏꞏꞏꞏꞏ 206
Packaging Integrity Evaluation of Sterile Productsꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 210
Tablet Hardness Determinations ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 213(2) Revision
Capillary Electrophoresis ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 214
On the Scientific Names of Crude Drugs listed in the JPꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 221
Revision of the description of crude drugs (odor and taste)
for listed articles (official monographs) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 222
Additional Revision of the Revision Drafts for JP 18
General Notices ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 223

Authority Announcements
JP17 table of errata（March 29, 2019） ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 134

Useful Information
PMRJ Reference Standards Ordering Information forForeign Users ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 224

次号（28 巻 3 号）出版月：2019 年 9 月
Publishing Schedule (Vol.28, No.3): September 2019