中国当代医药2025，Vol.32Issue(6)：187-192,6.DOI:10.3969/j.issn.1674-4721.2025.06.40
药品中亚硝胺类杂质研究概述
Overview of research on nitrosamine impurities in drugs
摘要
Abstract
In recent years,due to the high carcinogenic risk of nitrosamine impurities in drugs,there is a great hidden dan-ger to human health and safety,which has aroused the high attention of drug regulatory agencies and pharmaceutical companies in various countries.Drug regulatory agencies in various countries have successively issued relevant guidelines on nitrosamine impurities to guide the risk assessment and effective control of nitrosamine impurities.In this paper,the background and origin of nitrosamine impurities are introduced,and the control of nitrosamine impurities,including risk assessment,control limits and control strategies,is elaborated in combination with the current guidelines on nitrosamine impurities related to drugs issued by National Medical Products Administration,Food and Drug Administration and European Medicines Agency.The purpose of this paper is to review the latest regulatory policies and regulatory limits of nitrosamine impurities,in order to provide reference for the relevant research and control of nitrosamine impurities,and to achieve the minimum exposure of nitrosamine impurities in drugs.关键词
亚硝胺类杂质/药品/致癌性/控制策略Key words
Nitrosamine impurities/Medicine/Carcinogenicity/Control strategy分类
药学引用本文复制引用
丁嘉信,李荣荣,史乙伟,孙启泉..药品中亚硝胺类杂质研究概述[J].中国当代医药,2025,32(6):187-192,6.基金项目
山东省烟台市产业领军人才项目. （）
