化学药物杂质研究的技术指导原则.pdfVIP

指导原则编号： 【H 】G P H 3 - 1 化学药物杂质研究的技术指导原则 二○○五年三月 目 录 一、概述·····················································································································································1 二、杂质的分类····································································································································2 三、分析方法·········································································································································3 (一)分析方法的选择···························································································································3 1、有机杂质的分析方法 ············································································································3 2、无机杂质的分析方法 ············································································································3 (二)分析方法的验证······························································