中国食品药品监管Issue(6)：58-69,12.DOI:10.3969/j.issn.1673-5390.2025.06.008
卤代烃类遗传毒性杂质研究进展
Research Progress on Genotoxic Impurities of Halogenated Hydrocarbons
摘要
Abstract
In recent years,regulatory authorities and pharmaceutical R&D institutions have placed increasing emphasis on the control of genotoxic impurities in drugs.Halogenated hydrocarbons represent a class of potential genotoxic impurities that may be introduced through various pathways or generated by drug degradation.Effective control of these impurities is essential to ensure drug quality and patient safety.This paper provides a systematic review of current research on genotoxic impurities of halogenated hydrocarbons,covering structure alerts,sources,toxicological mechanisms,control strategies,evaluation methods,and recent advances in detection technologies.The aim is to provide a reference for the evaluation and control of halogenated hydrocarbon genotoxic impurities in pharmaceuticals.关键词
遗传毒性/药物卤代烃类杂质/毒性机制/毒理学评价/研究进展Key words
genotoxicity/halogenated hydrocarbon impurities/toxic mechanism/toxicological evaluation/research progress分类
化学化工引用本文复制引用
林榆子,黄海伟,胡笑文,张静,吴静芳,伍良涌,丁怡,陈华..卤代烃类遗传毒性杂质研究进展[J].中国食品药品监管,2025,(6):58-69,12.基金项目
广东省药品监督管理局化学药品制剂质量分析重点实验室科技项目(2018ZDB07) （2018ZDB07）
