Analysis of Harmonization Strategies between Elemental Impurities Standards for Pharmaceutical Excipients in the Chinese Pharmacopoeia and ICH Q3D
10.3870/j.issn.1004-0781.2025.02.008
- VernacularTitle:《中华人民共和国药典》药用辅料相关标准中元素杂质与ICH Q3D协调策略分析
- Author:
Lirong CAI
1
;
Lei CHEN
;
Changliang LI
;
Jinfeng ZHENG
;
Yanming LIU
Author Information
1. 湖南省药品检验检测研究院,国家药品监督管理局药用辅料工程技术研究重点实验室,长沙 410001
- Publication Type:Journal Article
- Keywords:
Chinese pharmacopeia;
Pharmaceutical excipients;
ICH Q3D;
Elemental impurities
- From:
Herald of Medicine
2025;44(2):223-227
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyze and evaluate the differences between the standards for elemental impurities in pharmaceutical excipients in the"Chinese Pharmacopoeia"and ICH Q3D,and to explore strategies for harmonization between them.Methods This study summarizes and reviews the main differences between the general chapters and specific monographs of pharmaceutical excipients in the 2020 edition of the"Chinese Pharmacopoeia"and its first supplement,compared with ICH Q3D.Results By integrating the harmonization strategies for elemental impurities in foreign pharmacopoeias and the risk assessment results for pharmaceutical excipients,this study proposes harmonization strategies and pathways for the standards of pharmaceutical excipients in the"Chinese Pharmacopoeia."Conclusions A systematic risk assessment of elemental impurities in pharmaceutical excipients in the"Chinese Pharmacopoeia"should be conducted based on their risk levels.The revision methods should be determined and continuously updated according to the assessment results.
