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

Vol. 31

No. 1

March 2022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（意見募集終了）
１. 一般試験法(1) 既収載
9.41 試薬・試液 ············································1
２. 医薬品各条（化学薬品等）(1) 既収載
ボグリボース錠 ·············································1
第十八改正日本薬局方第一追補に収載予定の改正案（報告）１. 一般試験法(1) 既収載
3.04 粒度測定法 ···········································2
２. 医薬品各条（化学薬品等）(1) 既収載
エタノール ···················································4
無水エタノール ·············································4
３. 医薬品各条（生薬等）(1) 既収載 ·······················································4
ショウズク ···················································4
ニクズク ······················································4
第十八改正日本薬局方第一追補に収載予定の改正案の見送り（報告）１. 一般試験法(1) 既収載
6.07 注射剤の不溶性微粒子試験法 ···················5(2) 削除6.17 タンパク質医薬品注射剤の不溶性微粒子試験
法 ·······························································5
２. 医薬品各条(化学薬品等)(1) 既収載
カルメロースナトリウム ·································5
精製白糖 ······················································5
３. 参照赤外吸収スペクトル
カルメロースナトリウム ·································5

第十八改正日本薬局方第二追補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 ·········································· 6
第十八改正日本薬局方第二追補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
インチンコウ ················································ 7
キクカ ························································· 7
レンニク ······················································ 7
既収載品目（医薬品各条(生薬等)）の生薬の性状の鏡検に関する 記載の改正について（意見募集）
カッコン ······················································ 8
シンギ ························································· 8
センナ ························································· 8
タンジン ······················································ 8
ブシ ···························································· 8
ボクソク ······················································ 9
モクツウ ······················································ 9

薬局方関連通知など

Useful Information

第十九改正日本薬局方原案作成要領(案)に関するご意見募集について(意見募集終了) ···························· 10
日本薬局方収載原案意見募集(令和 3 年 12 月 24 日分)に係るカラム情報の公開について ······················· 121
日本薬局方医薬品各条(生薬等)原案に係るカラムの情報の公開について ············································ 122

国際調和

Pharmacopoeial Harmonization

１ ． 日 米 欧 三 薬 局 方 調 和 合 意 文 書 (HarmonizedDocument)(1) 試験法1)改正①Chromatography ···································· 124ii2)訂正①Particle Size Distribution by Analytical Sieving(Correction) ·············································· 147(2) 各条1)新規①Petrolatum ············································ 153②White Petrolatum ··································· 1632)改正・訂正・表紙改正①Stearic Acid(Revision 2) ··························· 171②Cellulose, Powdered(Correction) ··············· 178③Hypromellose Phthalate (Correction 1) ······ 182④Ethanol (Correction of Sign-off Cover Sheet)187⑤ Ethanol, Anhydrous (Correction of Sign-offCover Sheet) ············································· 189⑥ Anhydrous Dibasic Calcium Phosphate(Correction of Sign-off Cover Sheet) ·············· 191⑦Cellulose, Microcrystalline (Correction of Signoff Cover Sheet) ········································· 193⑧Cellulose Acetate Phthalate (Correction of Signoff Cover Sheet) ········································· 195⑨ Crospovidone (Correction of Sign-off CoverSheet) ······················································ 197⑩ Hydroxyethylcellulose (Correction of Sign-offCover Sheet) ············································· 199⑪ Hydroxypropylcellulose (Correction of Sign-off
Cover Sheet) ············································· 201⑫Hydroxypropylcellulose,Low-substituted(Correction of Sign-off Cover Sheet) ·············· 203⑬ Hypromellose (Correction of Sign-off CoverSheet) ····················································· 205⑭ Methylcellulose (Correction of Sign-off CoverSheet) ····················································· 207⑮Sodium Starch Glycolate (Correction of Sign-off
Cover Sheet) ············································ 209⑯ Wheat Starch (Correction of Sign-off CoverSheet) ····················································· 211⑰Gelatin (Correction of Sign-off Cover Sheet) 213⑱ Mannitol (Correction of Sign-off Cover Sheet)······························································ 215(3) その他
1)改正① PDG Statement of Harmonisation Policy(Revision October 2021) ····························· 217② PDG Working Procedure (Revision version 3)······························································ 220

海外薬局方情報

Foreign Pharmacopoeial Information

ナノマテリアルを利用する医薬品の In-Vitro 製品性能評
価：USP 専門家パネルの見解··························· 231

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 ················· 247
USP 標準品の取次販売のご案内 ······················ 256
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 ··································· 258～～～～～～～～～～～～～～～

Contents in English
Revision Drafts
Revision Drafts for First Supplement to JP 18
１. General Tests, Processes and Apparatus(1) Revision
3.04 Particle Size Determination ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 264
9.41 Reagents, Test Solutions ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 267
２. Official Monographs(1) Revision
Ethanol ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 267
Anhydrous Ethanol ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 267
Magnesium Stearate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 268
Voglibose Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 268
３. Official Monographs－Crude Drugs(1) RevisionCardamon ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 268
Nutmeg ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 268
Cancel of Revision Drafts for First Supplement to JP18
１. General Tests, Processes and Apparatus(1) Revision
6.07 Insoluble Particulate Matter Test for Injections 269(2) Deletion
6.17 Insoluble Particulate Matter Test for TherapeuticProtein Injections ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 269
２. Official Monographs(1) Revision
Carmellose Sodium ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 269

iii[日局改正案]

Sucrose ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 269
３. Infrared Reference Spectra
Carmellose Sodium ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 269
Revision Drafts for Second Supplement to JP 18
１. General Tests, Processes and Apparatus(1) Revision
5.01 Crude Drugs Test ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 270
２. Official Monographs－Crude Drugs(1) Revision
Artemisia Capillaris Flower ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 270
Chrysanthemum Flower ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 271
Nelumbo Seed ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 271
Revision of the description concerning microscopic
examination of crude drugs (official monographs)
Akebia Stem ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 272
Hedysarum Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 272
Processed Aconite Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 272
Pueraria Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 273
Quercus Bar ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 273
Salvia Miltiorrhiza Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 273
Senna Leaf ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 273

Useful Information
Disclosure of Information about Columns for JapanesePharmacopoeiaDraft Monographs for Crude Drugs ꞏꞏꞏ 274

Reference Standards
PMRJ Reference Standards Ordering Information forForeign Users ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 277

Pharmacopoeial Harmonization
１．Harmonized Document(1) Tests
1)Addition①Chromatography ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 1242) Correction① Particle Size Distribution by Analytical Sieving(Correction)ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 147(2) Monographs
1)Addition①Petrolatum ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 153②White Petrolatum ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 1632)Revision・Correction・Correction of Sign-off Cover
Sheet①Stearic Acid(Revision 2) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 171②Cellulose, Powdered(Correction) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 178③Hypromellose Phthalate (Correction 1)ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 182④Ethanol (Correction of Sign-off Cover Sheet) ꞏꞏꞏꞏ 187⑤Ethanol, Anhydrous (Correction of Sign-off CoverSheet) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 189⑥Anhydrous Dibasic Calcium Phosphate (Correctionof Sign-off Cover Sheet) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 191⑦Cellulose, Microcrystalline (Correction of Sign-off
Cover Sheet) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 193⑧Cellulose Acetate Phthalate (Correction of Sign-off
Cover Sheet) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 195⑨ Crospovidone (Correction of Sign-off CoverSheet) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 197⑩Hydroxyethylcellulose (Correction of Sign-off CoverSheet) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 199⑪ Hydroxypropylcellulose (Correction of Sign-off
Cover Sheet) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 201⑫Hydroxypropylcellulose,Low-substituted(Correction of Sign-off Cover Sheet) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 203⑬ Hypromellose (Correction of Sign-off CoverSheet) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 205⑭Methylcellulose (Correction of Sign-off Cover Sheet)ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 207⑮ Sodium Starch Glycolate (Correction of Sign-offCover Sheet) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 209⑯ Wheat Starch (Correction of Sign-off CoverSheet) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 211⑰Gelatin (Correction of Sign-off Cover Sheet) ꞏꞏꞏꞏ 213⑱Mannitol (Correction of Sign-off Cover Sheet) ꞏꞏ 215(3) Others
1)Revision①PDG Statement of Harmonisation Policy (RevisionOctober 2021) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 217②PDG Working Procedure (Revision version 3) ꞏꞏꞏ 220

次号（31 巻 2 号）出版月：2022 年 6 月
Publishing Schedule (Vol.31, No.2): June 2022