Method Development and Validation for the Detection of Elemental Impurities in Drugs
10.3870/j.issn.1004-0781.2025.02.007
- VernacularTitle:药物中元素杂质检测方法的开发及验证
- Author:
Xue FENG
1
;
Yanchen HU
;
Yamin WANG
;
Lei CHEN
;
Li ZHU
Author Information
1. 国家药品监督管理局药品审评中心,北京 100076
- Publication Type:Journal Article
- Keywords:
Elemental impurities;
ICH Q3D;
Inductively coupled plasma-atomic emission spectrometry(ICP-AES);
Inductively coupled plasma-mass spectrometry(ICP-MS)
- From:
Herald of Medicine
2025;44(2):213-222
- CountryChina
- Language:Chinese
-
Abstract:
The study and control of elemental impurities are crucial for ensuring the quality and safety of drugs.The ICH has published the Q3D guideline as a globally harmonised approach for the research and control of elemental impurities in drugs.In accordance with the requirements of the ICH Q3D guideline for risk assessment and control of elemental impurities,how to carry out the development and validation of detecting methods for elemental impurities is important to analysts.In this research,the key points of ICP-AES and ICP-MS method development are summarized,including the determination of the types and limits of the elements to be measured,the selection of pretreatment methods,interferences and corrections;the validation requirements for the two methods in ICH Q2(R2)and different pharmacopoeial general rules are analyzed,and the evaluation methods of each validation experiments are compared in detail.This paper can provide a reference for the development and validation of detecting methods for elemental impurities,and research ideas for related research workers.
