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

Vol. 31 No. 4

December 2022

目次Contents
改正案

Revision Drafts

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
4.02 抗生物質の微生物学的力価試験法 ········· 589
9.41 試薬・試液 ······································· 589
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
6.10 溶出試験法 ······································· 591
２. 医薬品各条（化学薬品等）(1) 新収載
炭酸リチウム錠 ········································· 595
３. 医薬品各条（生薬等）(1) 既収載
チンピ ····················································· 596
ブシ ························································ 596
ヨクイニン ··············································· 596
ヨクイニン末 ············································ 597
既収載品目（医薬品各条(生薬等)）の生薬の性状の改正について（意見募集）
アマチャ ·················································· 597
インヨウカク ············································ 597
ウワウルシ ··············································· 598
ガイヨウ ·················································· 598
カッコウ ·················································· 598
センナ ····················································· 598
ソヨウ ····················································· 598
ニンドウ ·················································· 599
ハッカ ····················································· 599
ビワヨウ ·················································· 599
ヤクモソウ ··············································· 599

日本薬局方において削除予定の医薬品各条等について（意見募集）
１. 一般試験法(1) 削除9.01 標準品 ············································· 600
２. 医薬品各条（化学薬品等）(1) 削除アンレキサノクス ······································· 600
アンレキサノクス錠 ···································· 600
トルブタミド ············································· 600
トルブタミド錠 ·········································· 600

薬局方関連通知など

Useful Information

第十八改正日本薬局方正誤表の送付について（その 1）································································· 601
第十八改正日本薬局方（英文版）正誤表の送付について（その２） ··············································· 603

日本薬局方技術情報
Japanese Pharmacopoeial Technical Information

クロマトグラフィー総論 〈2.00〉 の新規収載，及び液体クロマトグラフィー〈2.01〉， ガスクロマトグラフィ
ー〈2.02〉の改正について ································ 604
17 品目の抗生物質標準品の NMR スペクトルライブラ
リと定量 NMR による純度······························ 608

国際調和Pharmacopoeial Harmonization

１. Stage 2 案 (Official Inquiry Stage Draft)(1)試験法1)改正①Dissolution ············································ 623

海外薬局方情報

Foreign Pharmacopoeial Information

USP の反復的アプローチによる規格開発と暫定規格(Emerging Standards)の概念 ··························· 633
USP 暫定規格(Emerging Standards)：アセトアミノフ
ェン注射液の分析法 ······································· 636

ii

USP 暫定規格(Emerging Standards)：パルボシクリブの分析法······················································ 651

標準品のご案内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 ··································· 677

総目次Reference Standards

日本薬局方等標準品の頒布のご案内·················· 666
USP 標準品の取次販売のご案内 ······················ 676

Cumulative ContentsVol. 31 総目次 ················································ 705～～～～～～～～～～～～～～～

Contents in English

Revision Drafts
Revision Drafts for Second Supplement to JP 18
１. General Tests, Processes and Apparatus(1) Revision
4.02 Microbial Assay for Antibiotics ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 681
6.10 Dissolution Test ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 682
9.41 Reagents, Test Solutions ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 687
２. Official Monographs(1) Addition
Lithium Carbonate Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 689
３. Official Monographs－Crude Drugs(1) Revision
Citrus Unshiu Peel ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 690
Coix Seed ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 691
Powdered Coix Seed ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 691
Processed Aconite Root ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 691Revision of the description of crude drugs (officialmonographs)
Artemisia Leaf ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 692
Bearberry Leaf ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 692
Epimedium Herbꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 692
Leonurus Herb ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 693
Lonicera Leaf and Stem ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 693
Loquat Leafꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 693
Mentha Herb ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 694
Perilla Herb ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 694
Pogostemi Herb ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 694
Senna Leaf ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 694
Sweet Hydrangea Leaf ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 695

Drafts for Second Supplement to JP18 regarding theMonographs Scheduled to be Deleted
１. General Tests, Processes and Apparatus(1) Deletion
9.01 Reference Standards ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 695
２. Official Monographs(1) Deletion
Amlexanox ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 695
Amlexanox Tabletsꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 695
Tolbutamide ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 695Tolbutamide Tablets ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 695

Reference Standards
PMRJ Reference Standards Ordering Information forForeign Users ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 696

Pharmacopoeial Harmonization
１. Official Inquiry Stage Draft(1)Tests
1)Revision①Dissolution ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 623

Cumulative ContentsVol. 31 Cumulative Contents ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 707

次号（32 巻 1 号）出版月：2023 年 3 月
Publishing Schedule (Vol.32, No.1): March 2023