Regulatory status and considerations on nitrosamine impurities in human drugs
WANG Gong-fu
TANG Jia
Abstract：Nitrosamine-type impurities are a class of compounds with potential genotoxicity.In recent years,being detected in many drugs,nitrosamine impurities have become the focus of regulatory authorities and pharmaceutical manufacturers,as well as patients.By reviewing the latest legal guidelines and related literature,this paper summarizes the research progress in the sources,control,limits,and detection methods of nitrosamine impurities,then puts forward considerations and prospects,hoping to provide reference for the research and regulation of drug R&D.
Keywords：nitrosamine impuritiesgenotoxicityregulatory
Publication Date：2024-02-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 221-228 )