气相色谱仪-顶空自动进样器性能确认方法的建立

Estabishment of GC-Headspace sampler Performance Qualification Method

建立气相色谱仪-顶空自动进样器性能确认的新方法。根据《气相色谱仪检定规程》提供的方法,结合《中国药典》及欧洲官方药品控制实验室网络《质量保证文件》的要求,总结气相色谱仪-顶空自动进样器性能确认参数,建立该仪器性能确认检测方法。检测结果与性能确认参数比较,结果符合实际。

A new method for the performance qualification of GC-Headspace sampler was established. According to the method provided by the Verification Regulation of Gas Chromatographs, combined with the requirement of Chinese Pharmacopoeia and OMCL Network of the Council of EuropeQuality Assurance Document,PQofGC-Headspace sampler was established by summarying the parameters level of the instrument.The detection results accord the reality.