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

Vol. 27

No. 4

December 2018

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
9.41 試薬・試液 ······································· 567
9.62 計量器・用器 ···································· 567
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（生薬等）(1) 既収載
カッコウ ·················································· 568
サンヤク ·················································· 568
ニクズク ·················································· 568
ベラドンナコン ········································· 568
リョウキョウ ············································ 568
レンニク ·················································· 568
ロートコン ··············································· 568
既収載品目（医薬品各条）の基原の記載の改正について（意見募集）
インスリン ヒト(遺伝子組換え)·················· 569
インスリン グラルギン(遺伝子組換え)········· 569
エポエチン アルファ(遺伝子組換え)············ 569
エポエチン ベータ(遺伝子組換え)··············· 569
セルモロイキン(遺伝子組換え)····················· 569
テセロイキン(遺伝子組換え)························ 569
ナルトグラスチム(遺伝子組換え)·················· 569
フィルグラスチム(遺伝子組換え)·················· 569
ヘパリンカルシウム ··································· 569
ヘパリンナトリウム ··································· 569
レノグラスチム(遺伝子組換え)····················· 569
オキシトシン ············································ 569
カルシトニン サケ ··································· 569
リゾチーム塩酸塩 ······································ 569
既収載品目（医薬品各条）の味の表記の改正について（意見募集）(化学薬品等各条)
アプリンジン塩酸塩 ··································· 570
アミノ安息香酸エチル ································ 570
オキシブプロカイン塩酸塩 ·························· 570

ジフェンヒドラミン ···································· 570
ジフェンヒドラミン塩酸塩 ··························· 570
テトラカイン塩酸塩 ···································· 570(生薬等各条)サイシン ··················································· 570
サンショウ ················································ 570
サンショウ末 ············································· 570
チョウジ ··················································· 570
チョウジ末 ················································ 570
ロートエキス・アネスタミン散 ····················· 570
シャゼンソウ ············································· 570
ジュウヤク ················································ 570
ブクリョウ ················································ 570
ブクリョウ末 ············································· 570
第十七改正日本薬局方第二追補に収載又は改正予定の見送りについて（報告）１. 一般試験法(1) 既収載
2.65 色の比較試験法 ································· 571
２. 医薬品各条（化学薬品等）(1) 新収載
ペグインターフェロン アルファ－2b(遺伝子組換え) ··························································· 571

薬局方関連通知など

Authority Announcements

第十七改正日本薬局方第一追補英文版の公開について································································· 572

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①Disintegration (Rev. 1, Corr. 1) ················· 573②Dissolution (Rev. 3, Correction of sign-off coversheet)······················································· 574③ Microbiological Examination of Non-sterile

ii

Products: Acceptance Criteria for Pharmaceutical
Preparations and Substances for PharmaceuticalUse (Correction of sign-off cover sheet) ········· 575(2) 各条1) 新規①Copovidone ············································ 5762) 改正・訂正・表紙改正①Cellulose, Microcrystalline (Rev. 3) ··········· 577②Wheat starch (Rev. 3) ······························ 579③Gelatin, Gelling grade (Rev. 2)·················· 581④Gelatin, Non-gelling grade (Rev.2) ············ 583⑤Crospovidone (Correction of sign-off cover sheet)······························································· 584⑥Mannitol (Correction of sign-off cover sheet)······························································· 585⑦Isomalt (Correction of sign-off cover sheet)······························································· 587

海外薬局方情報

Foreign Pharmacopoeial Information

各条作成のための技術ガイド (EP) ·················· 588
製薬業界のための測定の不確かさ ······················ 614

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 ················· 636
アメリカ薬局方標準品の取次販売のご案内 ········ 654
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 ··································· 656総目次

Cumulative Contents

Vol.27 総目次 ·············································· 684～～～～～～～～～～～～～～～

Contents in English

Revision Drafts
Drafts for JP 18
１. General Tests, Processes and Apparatus(1) Revision
9.41 Reagents, Test Solutions ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 662
9.62 Measuring Instruments, Appliances ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 662
２. Official Monographs－Crude Drugs(1) Revision
Alpinia Officinarum Rhizome ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 663
Belladonna Rootꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 663
Dioscorea Rhizome ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 663
Nelumbo Seed ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 663
Nutmeg ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 663
Pogostemon Herb ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 663
Scopolia Rhizome ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 663
Revision of the description of origins for listed articles(official monographs)
Celmoleukin (Genetical Recombination) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 664
Epoetin Alfa (Genetical Recombination) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 664
Epoetin Beta (Genetical Recombination) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 664
Filgrastim (Genetical Recombination) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 664
Heparin Calcium ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 664
Heparin Sodium ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 664
Insulin Glargine (Genetical Recombination) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 664
Insulin Human (Genetical Recombination) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 664
Lenograstim (Genetical Recombination) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 664
Nartograstim (Genetical Recombination) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 664
Teceleukin (Genetical Recombination) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 664

Calcitonin Salmon ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 664
Lysozyme Hydrochloride ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 664
Oxytocin ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 664
Revision of the description of taste for listed articles(official monographs)(Official Monographs－Chemical drugs)
Aprindine Hydrochloride ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 665
Diphenhydramine ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 665
Diphenhydramine Hydrochlorideꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 665
Ethyl Aminobenzoate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 665
Oxybuprocaine Hydrochloride ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 665
Tetracaine Hydrochloride ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 665(Official Monographs－Crude Drugs)
Asiasarum Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 665
Clove ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 665
Powdered Clove ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 665
Japanese Zanthoxylum Peel ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 665
Powdered Japanese Zanthoxylum Peel ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 665
Scopolia Extract and Ethyl Aminobenzoate Powder ꞏꞏ 665
Houttuynia Herb ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 666
Plantago Herb ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 666Poria Sclerotium ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 666
Powdered PoriaSclerotium ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 666
Cancel of Addition or Revision Drafts for Second
Supplement to JP 17
１. General Tests, Processes and Apparatus(1) Revision
2.65 Methods for Color Matching ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 666
２. Official Monographs

ii(1) Addition
Peginterferon Alfa-2b (Genetical Recombination) ꞏꞏꞏ 666

Pharmacopoeial Harmonization
１. Sign-off Cover Sheet of Harmonized Document(1) General Tests
1) Revision・Correction・Revision of Cover Sheet①Disintegration (Rev. 1, Corr. 1) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 573②Dissolution (Rev. 3, Correction of sign-off cover sheet)ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 574③Microbiological Examination of Non-sterile Products:
Acceptance Criteria for Pharmaceutical Preparations andSubstances for Pharmaceutical Use (Correction of sign-offcover sheet) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 575(2) Monographs
1) Addition①Copovidone ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 576

2) Revision・Correction・Revision of Cover Sheet①Cellulose, Microcrystalline (Rev. 3) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 577②Wheat starch (Rev. 3) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 579③Gelatin, Gelling grade (Rev. 2) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 581④Gelatin, Non-gelling grade (Rev.2) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 583⑤Crospovidone (Correction of sign-off cover sheet)ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 584⑥Mannitol (Correction of sign-off cover sheet) ꞏꞏꞏꞏꞏꞏ 585⑦Isomalt (Correction of sign-off cover sheet) ꞏꞏꞏꞏꞏꞏꞏꞏ 587

Useful Information
PMRJ Reference Standards Ordering Information for
Foreign Users ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 667

Cumulative Contents
Vol.27 Cumultive Contents ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 687

次号（28 巻 1 号）出版月：2019 年 3 月
Publishing Schedule (Vol.28, No.1): March 2019