New Progress in the Control of Nitrosamine Impurities in Chemical Drugs
In view of the discovery of nitrosamine impurities in angiotensin Ⅱ receptor antagonists,histamine 2 receptor antagonists,antimicrobial drugs,antidiabetic drugs and other drugs,global regulatory agencies have significantly increased their supervision on nitrosamine impurities.Regulatory agencies in various countries have successively issued the corresponding guiding documents,developed risk assessment methods,and proposed control strategies for nitrosamine impurities in drugs.China has also successively introduced a series of guiding documents that are in line with the international standards to control nitrosamine impurities.However,in practical work,there are still difficulties in the generation pathways,risk assessment,and control strategies for nitrosamine impurities.This article mainly introduces the possible nitrosation pathways and formation causes of nitrosamine impurities in chemical drugs,as well as the overall requirements for the analysis methods.And the risk assessment and control strategies for nitrosamine impurities in chemical drugs proposed by the regulatory agencies in various countries are summarized,which can provide a reference for further research and control of nitrosamine impurities.