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

Vol. 33 No. 1

March 2024目

次Contents
改正案

薬局方関連通知など

Revision Drafts

第十九改正日本薬局方に収載予定の改正案(意見募集)
１. 製剤総則 ·······················································1
２. 一般試験法(1) 既収載
2.56 比重及び密度測定法 ·······························16.14 吸入剤の送達量均一性試験法 ···················29.41 試薬・試液等 ········································5３. 参考情報(1) 新収載
点鼻剤の噴霧量均一性試験法····························7(2) 既収載
微生物迅速試験法〈G4-6-190〉 ·························7
遺伝子解析による微生物の迅速同定法〈G4-7-190〉································································ 12
日本薬局方における標準品及び標準物質〈G8-1-190〉 ··············································· 14
第十九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
2.00 クロマトグラフィー総論 ······················· 17
2.66 元素不純物 ········································· 26
２. 医薬品各条（化学薬品等）(1) 既収載
カオリン ···················································· 29
ケイ酸マグネシウム ····································· 29
テストステロンエナント酸エステル················· 30
ベントナイト ·············································· 30
３. 医薬品各条（生薬等）(1) 既収載
ゴオウ ······················································· 30

Useful Information

JIS の改正に伴う一般試験法「2.56 比重及び密度測定法」の改正について ······································· 31
一般試験法「6.14 吸入剤の送達量均一性試験法」改正案及び新規参考情報案「点鼻剤の噴霧量均一性試験法」並びに「6.14 吸入剤の送達量均一性試験法」の改正に伴う製剤総則の改正について ·················· 32
一般試験法「2.00 クロマトグラフィー総論」の改正案について ······················································ 38

国際調和

Pharmacopoeial Harmonization１．薬局方調和国際会議調和合意文書 (HarmonizedDocument)(1) 試験法1)改正・訂正・表紙訂正①Bulk density of powders (Rev.4 Corr.1)········ 39②Chromatography (Corr.1) ·························· 46

海外薬局方情報

Foreign Pharmacopoeial Information

経粘膜製剤の in vitro 性能試験：USP 専門委員会の見解··································································· 70
温度マッピングによる医薬品保管区域の温度適格性評
価 ································································ 91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 ··················· 98
USP 標準品の取次販売のご案内 ······················· 108
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 ···································· 109～～～～～～～～～～～～～～～

ii

Contents in English
Revision Drafts
Additional Revision of the Revision Draft for Second
Supplement to JP 18
１. Official Monographs(1) Revision
Clindamycin Phosphate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 113
Drafts for JP 19
１. General Rules for Preparations(1) Revision
2-3. Sprays for Oro-mucosal Application ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 114
5-1-3. Metered-dose Inhalers ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 114
11-3-1. Aerosols for Cutaneous Application ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 114
２. General Tests, Processes and Apparatus(1) Revision
2.00 Chromatography ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 115
2.56 Determination of Specific Gravity and Densityꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 125
2.66 Elemental Impurities ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 126
6.14 Uniformity of Delivered Dose for Inhalationsꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 129
9.41 Reagents, Test Solutions ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 133
３. Official Monographs(1) Revision
Bentonite ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 135
Kaolin ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 135
Magnesium Silicate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 136
Testosterone Enanthate ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 137

４. Official Monographs－Crude Drugs(1) Revision
Oriental Bezoar ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 137
５. General Information(1) Addition
Uniformity of delivered dose of nasal preparationsꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 137(2) Revision
Rapid Microbial Methods <G4-6-190> ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 138
Rapid Identification of Microorganisms Based on
Genetic Analysis〈G4-7-190〉 ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 144
Reference Standards and Reference Materials
Specified in the Japanese Pharmacopoeia 〈G8-1190〉ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 147

Reference Standards
PMRJ Reference Standards Ordering Information for
Foreign Users ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 152

Pharmacopoeial Harmonization
１．Harmonized Document(1) Tests
1)Revision ・ Correction ・ Correction of sign-off
coversheet①Bulk density of powders (Rev.4 Corr.1) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 39②Chromatography (Corr.1) ꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏꞏ 46

次号（33 巻 2 号）出版月：2024 年 6 月
Publishing Schedule (Vol.33, No.2):June 2024