气相色谱仪性能验证方法的建立及应用

Establishment and Application of GC Performance Verification Method

建立气相色谱仪性能验证新方法,为申请WHO药品预认证提供保障。根据欧洲药品质量管理局《质量控制文件》提供的方法,结合《中国药典》要求,与我国计量检定规程进行对比,总结气相色谱仪性能验证参数要求,建立气相色谱仪性能验证检测方法,并用该方法对5台气相色谱仪进行检测,结果符合实际。

GC performance verification method was set up to apply for WHO prequalification provides evidence. According to the method provided by European Directorate for the Quality Control of Medicines and the requirement of Chinese Pharmacopoeia, and compared with Chinese meterage rules, performance validation of gas chromatography was established by summarying the parameters level of the gas chromatograph, five instruments was tested by the method and the detection results accord the reality.