药物中元素杂质检测方法的开发及验证  

Method Development and Validation for the Detection of Elemental Impurities in Drugs

作　　者：冯雪 胡延臣 王亚敏 陈蕾[2] 朱俐[3] FENG Xue;HU Yanchen;WANG Yamin;CHEN Lei;ZHU Li(Center for Drug Evaluation,National Medical Products Administration,Beijing 10006,China;Chinese Pharmacopoeia Commission,Beijing 100061,China;National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076 [2]国家药典委员会,北京100061 [3]中国食品药品检定研究院,北京102629

出　　处：《医药导报》2025年第2期213-222,共10页Herald of Medicine

摘　　要：元素杂质的研究和控制对于保障药物的质量和安全性具有重要意义,国际人用药品注册技术协调会(ICH)已发布实施ICH Q3D指南作为药物中元素杂质研究和控制的全球协调统一的指南。基于ICH Q3D指南对元素杂质风险评估和控制的要求,元素杂质检测方法的开发和验证是分析工作者的关注重点。该文主要综述电感耦合等离子体原子发射光谱法(ICP-AES)和电感耦合等离子体-质谱法(ICP-MS)方法开发的要点,包括确定待测元素种类和限度、前处理方法选择、干扰和校正;具体分析ICH Q2(R2)与各国药典通则关于元素杂质测定方法的验证要求,并详细对比说明各项验证试验的评价方式,为元素杂质检测方法的开发和验证提供参考,同时也为相关研究工作者提供研究思路。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.

关 键 词：元素杂质 ICH Q3D 电感耦合等离子体原子发射光谱法 电感耦合等离子体-质谱法 

分 类 号：R921[医药卫生—药学]