Evolution of Elemental Impurity Testing for Pharmaceutical Excipients in the Pharmacopeias of US,Europe,and Japan
10.3870/j.issn.1004-0781.2025.02.005
- VernacularTitle:欧洲美国日本药典药用辅料元素杂质检查的变革
- 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:
Pharmaceutical excipients;
United States pharmacopeia;
European Pharmacopeia;
Japanese pharmacopeia;
Elemental impurities
- From:
Herald of Medicine
2025;44(2):200-208
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyze the historical and current inclusion of heavy metals and specific elemental impurity tests in the monographs of pharmaceutical excipients in the Pharmacopeias of the US(USP),Europe(EP)and Japan(JP)pharmacopeias.By examining the characteristics and trends in these pharmacopeias,the study seeks to provide insights that can inform the strategy for incorporating elemental impurity tests in the Chinese Pharmacopoeia and offer guidance for the industry to enhance control over elemental impurities in drugs and excipients.Methods The study reviews the inclusion and revision processes of heavy metals and specific elemental impurity tests in the pharmacopeias of the US,Europe and Japan,focusing on aspects such as the number of excipient monographs,the proportion of heavy metal tests,professional categories,and treatment methods.A comparative analysis with the Chinese Pharmacopoeia was conducted to explore the reasons behind the observed differences and to identify potential future developments.Results The USP contains the largest number of excipient monographs,the EP has the fastest progress in the evaluation of elemental impurities in excipients,the JP relies most heavily on wet chemical methods for testing.Conclusion The strategies of the US,European,and Japanese pharmacopeias can serve as valuable references for the development of elemental impurity testing strategies in the Chinese Pharmacopoeia.It is recommended to classify pharmaceutical excipients by risk level,removing heavy metal tests for low-risk categories and conducting elemental impurity risk assessments for higher-risk mineral-based excipients.The inclusion of specific elemental impurity tests should be determined based on these risk assessments,with specific limits or methods established as needed according to excipient category or individual monographs.
