Control strategies for nitrosamine impurities in rifampin and rifapentin
This article reviews the control strategies of the nitrosamine impurities,such as 1-methyl-4-nitrosopiperazine(MNP)in rifampin and 1-cyclopentyl-4-nitrosopiperazine(CPNP)in rifapentine by FDA,WHO and EMA,in order to to provide a reference for Chinese drug regulatory agency and Marketing Authorization Holder to establish the control limit of nitrosamine impurities in the two drugs.Meanwhile,the cause,acceptable limits and detection methods of nitrosamine impurities in rifampin and rifapentine are analyzed,and the methods of reducing the content of the impurities are discussed.Referring to the experience of foreign regulatory agencies,suggestions are put forward on the prevention and control measures of nitrosamine impurities in the two tuberculosis drugs in China.
NETL
NSTL
万方数据
维普
