Quality assessment of imipenem and cilastatin sodium for injection
Objective This study evaluated the quality status of imipenem and cilastatin sodium for injection from different manufacturers in the domestic market,found out the quality risk points,and provided key quality control points for the consistency evaluation of generic drugs.Methods The statutory testing methods combined with the exploratory research were used to examine samples,and the quality status of imipenem and cilastatin sodium for injection and the differences between different manufacturers were also analyzed.Results According to the statutory testing of 80 baths,all complied with regulations.However,it was found that the original products were dissolved faster.There were significant differences in related substances and assays from the productions of different manufacturers.And there were significant differences in current standards;therefore,the statutory standards needed to be improved and unified.It was shown that the solubility of the sample was related to the crystal habit and granularity of imipenem by exploratory research.The source and the structure of some impurities were identified by LC/MS.The determination method of the assay was optimized.Conclusion The quality of imipenem and cilastatin sodium for injection in the domestic market was good;in conducting consistency evaluations of generic drugs,the crystal habit of imipenem,related substances,contents,nitrogen charging technology and mesityl oxide for the injection should be paid attention to.The statutory standards needed to be integrated and improved.
Imipenem and cilastatin sodium for injectionQuality analysisCrystal habitRelated substancesContents
万方数据
维普
