[技术帖]药品中有关物质HPLC方法验证.PDFVIP

2018/8/20 药物分析之家 [技术帖] 药品中有关物质 HPLC方法验证 J ulia 药物分析之家 2017-09-04 本文转载自Julia 药品中有关物质 HPLC方法验证 A nalytical Method Validation and Instrument Performance Verification, Edited by Chung Chow Chan, Herman Lam, Y. C. Lee, and Xue-Ming Z hang ISBN 0-471-25953-5 Copy right ? 2004 John Wiley Sons, Inc. MET HOD VA LIDATION FOR HPLC A NA LYSIS OF RELAT ED SUBSTA NCES IN PHA RMACEUTICA L DRUG PRODUCTS 药品中有关物质 HPLC方法验证 Y. C. LEE, PH.D. Patheon Y M, Inc. 目录 3.1 I NT RODUCTION 介绍 3.2 BACKGROUND I NFORMATION 背景介绍 3.2.1 Definitions 定义 3.2.2 Different Ty pes of Related Substance A nalysis 有关物质分析的不 同类型 3.2.3 Suitability of Related Substance A nalysis 有关物质分析的适用性 3.2.4 Preparation before Method Validation 方法验证的准备工作 3.3 MET HOD VA LI DATION EX PERI MENTS 方法验证试验 3.3.1 Specificity 专属性 3.3.2 Quantitation Limit (and/or Detection Limit) 定量限 （和/或检测限 ） 3.3.3 Linearity 线性 3.3.4 Accuracy 准确度 3.3.5 Precision 精密度 3.3.6 Range 范围 3.3.7 Robustness 耐用性 3.4 COMMON PROBLEMS A ND SOLUTIONS 常见问题和解决方法 3.5 REFERENCES 参考文献 3.1 I NT RODUCTION 介绍 In this chapter we outline the general requirements for analytical method validation for HPLC analysis of related substances in pharmaceutical products. Most of the discussion is based on method validation for pharmaceutical products of sy nthetic origin. Even though most of the requirements are similar for other ty pes of pharmaceutical drug products (e.g., biopharmaceutical drug products), detailed discussion of method validation for other ty pes of pharmaceutical drug products is outside the