Establishment of national reference substance of tenofovir
Objective:To establish the first batch of national reference substance of tenofovir,in order to provide guarantee for quality control of related drugs.Methods:The structure of tenofovir was identified by UV,IR,HRMS,and NMR.The content of tenofovir was determined by mass balance method,and was further verified by external standard method and volumetric method to ensure the accuracy of the quantification.The hygroscopicity of the reference substance was preliminarily studied by dynamic vapor sorption(DVS)analysis.Results:The result of the mass balance method was used as the content of the first batch of national reference substance,and the amount of tenofovir was 93.8%.The hygroscopicity study showed that the 6%moisture content of the reference substance tends to be stable.Conclusion:The first batch of national reference substance of tenofovir was successfully developed.
NETL
NSTL
万方数据
维普
