指导原则编号：化学药物质量控制分析方法验证技术指导原则二○○四年十一月【H】GPH5-1目录一、概述.....................................................................................................................1二、方法验证的一般原则.........................................................................................2三、方法验证涉及到的三个主要方面.....................................................................2（一）需要验证的检测项目.............................................................................2（二）分析方法.................................................................................................3（三）验证内容.................................................................................................3四、方法验证的具体内容.........................................................................................3（一）专属性.....................................................................................................31、鉴别反应.......................................................................................................32、杂质检查.......................................................................................................43、含量测定.......................................................................................................4（二）线性.........................................................................................................5（三）范围.........................................................................................................51、含量测定.......................................................................................................52、制剂含量均匀度...........................................................................................53、溶出度或释放度...........................................................................................64、杂质...............................................................................................................6（四）准确度.....................................................................................................61、含量测定.......................................................................................................62、杂质定量试验...............................................................................................7（五）精密度.....................................................................................................71、重复性...........................................................................................................72、中间精密度...................................................................................................83、重现性...........................................................................................................8（六）检测限.....................................................................................................81、直观法...........................................................................................................82、信噪比法.......................................................................................................8（七）定量限.....................................................................................................91、直观法.........................................................
