Quality control study on bacterial endotoxins and abnormal toxicity of moxifloxacin hydrochloride and sodium chloride injection for national evaluation sampling
Objective:To evaluate and study the current status of safety and quality control of moxifloxacin hydro-chloride and sodium chloride injection.Methods:Fifteen production enterprises nationwide producing moxifloxacin hydrochloride and sodium chloride injection were sampled and tested according to each manufacturer's respective quality standards.Additionally,the safety-related items of"bacterial endotoxins"and"abnormal toxicity"were further studied and expanded upon.The rationality of the existing standards was analyzed.Results:According to the standard test,the qualification rate of 187 batches of moxifloxacin hydrochloride was 100％.However,compa-ring the quality standards used by various enterprises,it was found that there are significant differences in their re-quirements for bacterial endotoxin projects and abnormal toxicity projects.After using a unified and stricter standard for expansion testing,all 187 batches of samples still passed.Conclusion:The overall quality of moxifloxacin hydrochloride and sodium chloride injection in China is satisfactory in terms of safety control.It is recommended to unify the safety standards according to the draft quality standard for"moxifloxacin hydrochloride and sodium chlo-ride injection"issued by the National Pharmacopoeia Commission.
moxifloxacin hydrochloride and sodium chloride injectionevaluation samplingbacterial endotoxinsabnormal toxicityquality analysis
万方数据
维普
