化学原料药元素杂质控制策略探索与思考  

Exploration and Reflection on the strategy of Controlling Elemental Impurities In Chemical Raw Materials

作　　者：王威[1] Wang Wei(Harbin Pharmaceutical Group Pharmaceutical General Factory,Harbin 150086,China)

机构地区：[1]哈药集团制药总厂,黑龙江哈尔滨150086

出　　处：《哈尔滨医药》2024年第3期44-46,共3页Harbin Medical Journal

摘　　要：元素杂质影响药品安全性和有效性,国际人用药品注册技术协调会(ICH)在2022年4月发布了《Q3D(R2):元素杂质指导原则》最终版。本文参考Q3D(R2)分析了化学原料药中元素杂质,识别出各种潜在来源的可能元素杂质,对生产角度各环节元素杂质的控制策略进行讨论,为后续药品研发、生产、质量控制和上市变更研究,提供了新的研究思路。Elemental impurities affect the safety and efficacy of drugs,and the International Council for Harmonization of Drugs for Human Use(ICH)released the final version of Q3D(R2):Guiding Principles for Elemental Impurities in April 2022.In this paper,we analyze the elemental impurities in chemical APIs with reference to Q3D(R2),identify the possible elemental impurities from various potential sources,and discuss the control strategies of elemental impurities in each link from the production perspective,which provides new research ideas for the follow-up research on drug R&D,production,quality control and marketing changes.

关 键 词：Q3D(R2) 化学原料药 元素杂质 控制策略 

分 类 号：R282.5[医药卫生—中药学]