Comparative Analysis of the Harmonization Strategies for Excipient Standards with ICH Q3D in the Pharmacopoeias of Europe,the United States,and Japan
10.3870/j.issn.1004-0781.2025.10.031
- VernacularTitle:欧洲美国日本药典药用辅料标准与ICH Q3D协调策略分析
- Author:
Lirong CAI
1
;
Changliang LI
;
Jinfeng ZHENG
;
Yanming LIU
;
Lei CHEN
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:
European pharmacopoeia;
United States pharmacopeia;
Japanese pharmacopoeia;
Pharmaceutical excipients;
ICH Q3D;
Elemental impurities
- From:
Herald of Medicine
2025;44(10):1701-1708
- CountryChina
- Language:Chinese
-
Abstract:
Objective To provide valuable references and insights for improving the excipient standard system of the Chinese Pharmacopeia and promoting its harmonization with ICH Q3D.By analyzing the harmonization strategies and implementation of excipient standards in the pharmacopoeias of Europe,the United States,and Japan.Methods Through a combination of literature review and case study analysis,this paper introduces the policies and strategies adopted by the pharmacopoeias of three major regions(Europe,the United States,and Japan)in implementing the ICH Q3D guidelines in the field of pharmaceutical excipients.Additionally,it reviews the updates on excipient standards in these regions and analyzes the characteristics of their alignment with ICH Q3D.Results The strategies for implementing ICH Q3D in pharmacopeial excipient standards vary across different regions,with each following distinct approaches and progressing at different rates.Notably,there are significant differences in the establishment of standards for elemental impurities.Conclusion Promoting the harmonization of pharmacopeial excipient standards with ICH Q3D is a challenging and long-term endeavor.It is essential to develop a harmonization strategy that is tailored to China's national context.
