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

Vol. 28

No. 3

September 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) 新収載
2.05 サイズ排除クロマトグラフィー ············ 239(2) 既収載
5.01 生薬試験法 ······································· 240
9.41 試薬・試液 ······································· 241
２. 参考情報(1) 新収載
生薬の放射能測定法 ··································· 244
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
2.66 元素不純物 ······································· 251
２. 医薬品各条（化学薬品等）(1) 新収載
イリノテカン塩酸塩注射液 ·························· 257
グルカゴン(遺伝子組換え) ··························· 259
ゲフィチニブ ············································ 260
セレコキシブ ············································ 261
ゾピクロン ··············································· 262
ゾピクロン錠 ············································ 264
ドルゾラミド塩酸塩・チモロールマレイン酸塩
点眼液 ·················································· 265
ビカルタミド ············································ 267
フェノフィブラート ··································· 269
フェノフィブラート錠 ································ 270
透析用ヘパリンナトリウム液························ 272
ロック用ヘパリンナトリウム液····················· 272
注射用メトトレキサート ····························· 273
リルマザホン塩酸塩水和物 ·························· 274
リルマザホン塩酸塩錠 ································ 275
ロスバスタチンカルシウム ·························· 276
ロスバスタチンカルシウム錠························ 278
ロフラゼプ酸エチル ··································· 280
ロフラゼプ酸エチル錠 ································ 282(2) 既収載
アザチオプリン錠 ······································· 283
クロスカルメロースナトリウム ····················· 283
酸素 ························································· 284
シロドシン ················································ 285
シロドシン錠 ············································· 286
乳糖水和物 ················································ 286
ノルゲストレル・エチニルエストラジオール錠···························································· 287
ピタバスタチンカルシウム水和物 ·················· 287
ピタバスタチンカルシウム錠 ························ 288
ブドウ糖注射液 ·········································· 289
プロタミン硫酸塩 ······································· 289
３. 医薬品各条（生薬等）(1) 既収載
カロコン ··················································· 289
ケイヒ ······················································ 289
ケイヒ油 ··················································· 289
ゴシュユ ··················································· 289
呉茱萸湯エキス ·········································· 289
サイコ ······················································ 290
サンショウ ················································ 291
テンモンドウ ············································· 291
ベラドンナコン ·········································· 291
マオウ ······················································ 291
４. 参照紫外可視吸収スペクトル
ゲフィチニブ ············································· 292
セレコキシブ ············································· 292
ゾピクロン ················································ 292
ビカルタミド ············································· 293
フェノフィブラート ···································· 293
リルマザホン塩酸塩水和物 ··························· 293
ロスバスタチンカルシウム ··························· 294
ロフラゼプ酸エチル ···································· 294
５. 参照赤外吸収スペクトル
クロスカルメロースナトリウム ····················· 294
ゲフィチニブ ············································· 295
セレコキシブ ············································· 295
JP Forum Vol. 28 No. 3 (2019)

ii

ゾピクロン ················································ 295
ビカルタミド ············································· 296
フェノフィブラート ···································· 296
リルマザホン塩酸塩水和物 ··························· 296
ロスバスタチンカルシウム ··························· 297
ロフラゼプ酸エチル ···································· 297
６. 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 ········· 298(2) 削除製剤中の元素不純物の管理 ··························· 298
既収載品目（医薬品各条）の光学異性体の記載の改正について（意見募集）
クロピドグレル硫酸塩 ································· 299
ドルゾラミド塩酸塩 ···································· 299
バラシクロビル塩酸塩 ································· 300
バルサルタン ············································· 300
パロキセチン塩酸塩水和物 ··························· 300
ベポタスチンベシル酸塩 ······························ 300
ボリコナゾール ·········································· 301
注射用ボリコナゾール ································· 301
モンテルカストナトリウム ··························· 301
レボフロキサシン水和物 ······························ 302
レボフロキサシン錠 ···································· 302
レボフロキサシン細粒 ································· 303
レボフロキサシン注射液 ······························ 303
既収載品目（9.41 試薬・試液）における 「定量用 1」の削除について（意見募集） ······································ 304
既収載品目（9.41 試薬・試液）の「内部基準物質」の用語に係る改正について（意見募集） ·························· 305
既収載品目（医薬品各条(生薬等)）のカラムの選定に係る記載の改正について（意見募集）
ウワウルシ ················································ 306
オウバク ··················································· 306
オウバク末 ················································ 306
オウレン ··················································· 306
オウレン末 ················································ 306
センソ ······················································ 306
トコンシロップ ·········································· 306
ハッカ油 ··················································· 306
ベラドンナコン ·········································· 306
ホミカ ······················································ 306
ホミカエキス散 ·········································· 306
ロートエキス散 ·········································· 306
既収載品目(医薬品各条(生薬等))の含量規格の改正について（意見募集）
サンシシ ··················································· 306
サンシシ末 ················································ 306
ボタンピ ··················································· 306
ボタンピ末 ················································ 306

JP Forum Vol. 28 No. 3 (2019)

既収載品目（医薬品各条(生薬等)）の定量法の秤取量（MS）に「qNMR で含量換算した」を追記する改正について（意見募集）桂枝茯苓丸エキス ······································ 307
五苓散エキス ············································ 307
桃核承気湯エキス ······································ 307
苓桂朮甘湯エキス ······································ 307
黄連解毒湯エキス ······································ 307
加味帰脾湯エキス ······································ 307
加味逍遙散エキス ······································ 307
サンシシ ·················································· 307
サンシシ末 ··············································· 307
ボタンピ ·················································· 307
ボタンピ末 ··············································· 307
コウボク ·················································· 307
コウボク末 ··············································· 307
半夏厚朴湯エキス ······································ 307
第十八改正日本薬局方において削除予定の医薬品各条等に関する改正案（意見募集）
１．医薬品各条（化学薬品等）(1) 削除品目
メチルロザリニン塩化物 ····························· 307
第十八改正日本薬局方に収載予定の改正案（報告）１．一般試験法(1) 既収載
2.52 熱分析法·········································· 308
4.06 無菌試験法······································· 308

日本薬局方技術情報
Japanese Pharmacopoeial Technical Information「6.16 半固形製剤の流動学的測定法」について ···· 309

薬局方関連通知など

Authority Announcements

第十七改正日本薬局方第二追補の制定等について ·· 311
第十七改正日本薬局方第二追補の制定に伴う医薬品製
造販売承認申請等の取扱いについて ················· 317
第十七改正日本薬局方第二追補の制定により削除された参考情報の取扱いについて ·························· 322
第十八改正日本薬局方原案作成要領（一部改正）案に関するご意見の募集について（意見募集終了） ····· 323
日本薬局方収載原案意見募集（令和元年 9 月分）に係るカラム情報の公開について ····························· 432
第十八改正日本薬局方の原案作成スケジュールについて ······························································ 434
一般試験法〈2.66〉元素不純物試験法の改正案について································································· 435

iii

国際調和

Pharmacopoeial Harmonization

１.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①Color (Rev.1) ········································· 436

海外薬局方情報

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 ·················· 455
アメリカ薬局方標準品の取次販売のご案内 ········· 464
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 ···································· 465

Foreign Pharmacopoeial Information

医薬品連続製造に関する USP（局方）の見通し ···· 438～～～～～～～～～～～～～～～

Contents in English
Revision Drafts
Drafts for JP 18
１. General Tests, Processes and Apparatus(1) Additoin
2.05 Size-Exclusion Chromatography ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 470(2) Revision
2.66 Elemental Impurities ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 471
9.41 Reagents, Test Solutions ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 479
２. Official Monographs(1) Addition
Bicalutamide ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 480
Celecoxibꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 482
Dorzolamide Hydrochloride and Timolol
Maleate Ophthalmic Solution ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 484
Ethyl Loflazepate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 486
Ethyl Loflazepate Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 488
Fenofibrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 489
Fenofibrate Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 491
Gefitinib ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 493
Glucagon (Genetical Recombination) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 495
Heparin Sodium Lock Solution ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 497
Heparin Sodium Solution for Dialysis ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 498
Irinotecan Hydrochloride Injection ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 498
Methotrexate for Injection ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 500
Rilmazafone Hydrochloride Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 501
Rilmazafone Hydrochloride Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 503
Rosuvastatin Calcium ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 504
Rosuvastatin Calcium Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 507
Zopicloneꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 510
Zopiclone Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 511(2) Revision
Azathioprine Tabletsꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 512
Glucose Injectionꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 513

Lactose Hydrateꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 513
Norgestrel and Ethinylestradiol Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 513
Pitavastatin Calcium Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 513
Pitavastatin Calcium Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 514
Protamine Sulfate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 516
Silodosin ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 516
Silodosin Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 517(3) Deletion
Methylrosanilinium Chloride ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 518
３. Official Monographs－Crude Drugs(1) Revision
Asparagus Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 518
Belladonna Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 518
Cinnamon Bark ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 518
Cinnamon Oil ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 519
Ephedra Herbꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 519
Euodia Fruit ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 519
Japanese Zanthoxylum Peel ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 519
Trichosanthes Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 519
４. Infrared Reference Spectra
Bicalutamide ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 520
Celecoxib ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 520
Croscarmellose Sodium ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 521
Ethyl Loflazepate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 521
Fenofibrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 521
Gefitinib ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 522
Rilmazafone Hydrochloride Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 522
Rosuvastatin Calcium ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 522
Zopiclone ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 523
５. Ultraviolet-visible Reference Spectra
Bicalutamide ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 523
Celecoxib ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 523
Ethyl Loflazepate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 524
Fenofibrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 524
JP Forum Vol. 28 No. 3 (2019)

iv

Gefitinib ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 524
Rilmazafone Hydrochloride Hydrate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 525
Rosuvastatin Calcium ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 525
Zopiclone ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 525
６. General Information(1) Revision
On the Scientific Names of Crude Drugs listed in
the JP ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 526(2) Deletion
Control of Elemental Impurities in Drug Products ꞏ 526
Revision of the description of column selection for listed
articles (official monographs)
Bearberry Leaf ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 527
Belladonna Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 527
Coptis Rhizome ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 527
Ipecac Syrup ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 527
Mentha Oil ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 527
Nux Vomica ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 527
Nux Vomica Extract Powder ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 527
Powdered Coptis Rhizome ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 527
Phellodendron Bark ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 527
Powdered Phellodendron Bark ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 527
Scopolia Extract Powder ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 527
Toad Cake ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 527
Revision of the limit of content of crude drugs for listed
articles (official monographs)
Gardenia Fruit ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 528
Powdered Gardenia Fruit ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 528
Moutan Bark ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 528
Powdered Moutan Bark ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 528

Revision of the description of crude drugs (addition of thesentence, “calculated on the basis of the content obtainedby qNMR”, to taken amount (MS) in the Assay) for listed
articles (official monographs)
Goreisan Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 529
Keishibukuryogan Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 529
Ryokeijutsukanto Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 529
Tokakujokito Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 529
Gardenia Fruit ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 529
Powdered Gardenia Fruit ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 529
Kamikihito Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 529
Kamishoyosan Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 529
Orengedokuto Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 529
Moutan Bark ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 529
Powdered Moutan Bark ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 529
Magnolia Bark ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 529
Powdered Magnolia Barkꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 529
Hangekobokuto Extract ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 529

Pharmacopoeial Harmonization
１. Sign-off Cover Sheet of Harmonized Document(1) General Tests
1) Revision・Correction・Revision of Cover Sheet①Color (Rev.1) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 436

Useful Information
PMRJ Reference Standards Ordering Information for
Foreign Users ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 530

次号（28 巻 4 号）出版月：2019 年 12 月
Publishing Schedule (Vol.28, No.4): December 2019

JP Forum Vol. 28 No. 3 (2019)