洛施德gmp咨询 - 药品中有关物质的hplc方法验证

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1、SoltorisManagementConsultants,Inc.洛施德企业管理咨询（上海）有限公司METHODVALIDATIONFORHPLCANALYSISOFRELATEDSUBSTANCESINPHARMACEUTICALDRUGPRODUCTS药品中有关物质HPLC方法验证Y.C.LEE,PH.D.PatheonYM,Inc.第1页/共34页www.soltoris.com,SoltorisManagementConsultants,Inc.info@soltoris.comSoltorisManagementConsultant

2、s,Inc.洛施德企业管理咨询（上海）有限公司Content目录3.1INTRODUCTION介绍........................................................................................................................................33.2BACKGROUNDINFORMATION背景介绍.............................................................

3、............................................33.2.1Definitions定义...............................................................................................................................................33.2.2DifferentTypesofRelatedSubstanceAnalysis有关物质分析的不同类型............

4、....................................53.2.3SuitabilityofRelatedSubstanceAnalysis有关物质分析的适用性............................................................103.2.4PreparationbeforeMethodValidation方法验证的准备工作....................................................................123.3METH

5、ODVALIDATIONEXPERIMENTS方法验证试验.....................................................................................153.3.1Specificity专属性...........................................................................................................................................1

6、53.3.2QuantitationLimit(and/orDetectionLimit)定量限（和/或检测限）.......................................................173.3.3Linearity线性................................................................................................................................................20

7、3.3.4Accuracy准确度............................................................................................................................................223.3.5Precision精密度....................................................................................................

8、.......................................253.3.6Range范围......................