Quality control study on bacterial endotoxins and abnormal toxicity of moxifloxacin hydrochloride and sodium chloride injection for national evaluation sampling
10.19778/j.chp.2024.03.010
- VernacularTitle:国家评价性抽验盐酸莫西沙星氯化钠注射液的细菌内毒素和异常毒性质量控制研究
- Author:
Siting XIAO
1
;
Xuemei LI
;
Bo GUAN
;
Yu LI
;
Chunran CAO
Author Information
1. 北京市药品检验研究院,国家药品监督管理局创新药物安全研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京 102206
- Keywords:
moxifloxacin hydrochloride and sodium chloride injection;
evaluation sampling;
bacterial endotoxins;
abnormal toxicity;
quality analysis
- From:
Drug Standards of China
2024;25(3):277-281
- CountryChina
- Language:Chinese
-
Abstract:
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.
