Analytical Method Development and Validation分析方法的建立和验证 28 March 2008Outline总纲z HPLC Method Development 高效液相方法建立高效液相方法建立z HPLC Trouble-shooting GuideHPLC问题解答问题解答z Method Optimization方法优化方法优化z Method Validation方法验证方法验证z System Suitability Requirements系统适应性要求系统适应性要求z GMP“Mind-set”GMP理念理念Method Development Method Classification方法开发分析方法分类z Assay Method 含量方法z Impurity Profile 杂质情况 -Related Substances 有关物质z Chiral Purity 手性纯度z Content Uniformity 含量均一性z Dissolution z Cleaning Validation 清洁验证z Identity F
