Quality assessment of cefazole sodium for injection
Objective This study evaluated the quality of cefazole sodium for injection in China.Methods The quality of cefazole sodium injection was assessed,along with its current specifications,in accordance with the legal standard determination and exploratory research.This included looking into related substances,polymer impurities,residual solvents,2-mercaptobenzothiazole,salt formation rate,and other important product quality attributes.Results The qualified rate of 238 batches of samples was 100.0％according to the legal specifications.The results of exploratory research showed that the legal specifications had some deficiencies in impurity control and polymer determination.The acetic acid residue of individual samples exceeded the limit;the genotoxic impurity 2-mercaptobenzothiazole was detected in some samples.There was no significant difference in the salt formation rate of samples from different manufacturers.Conclusion The quality of cefazoxime sodium for injection in China was good.The current specifications should be further unified and improved.It was proposed to improve the control of polymer impurities and related substances.It is suggested that manufacturers should pay attention to the residue of"acetic acid"in the process and the potential risk of 2-mercaptobenzothiazole.
Cefazoxime sodium for injectionEvaluative samplingQuality assessmentPolymer2-mercaptobenzothiazole
万方数据
维普
