药物研究技术指导原则(2005年)sfda.pdfVIP

指导原则编号： 【H 】 G P H 7 - 1 化学药物残留溶剂研究的技术指导原则 二 OO 五年三月 1 目 录 一、概述······································································································································1 二、基本内容···························································································································2 (一)残留溶剂研究的基本原则·············································································2 1、确定残留溶剂的研究对象·············································································2 2、确定残留溶剂时需要考虑的问题 ·····························································2 3、残留溶剂分类及研究原则·············································································4 (二)研究方法的建立及方法学验证·································································6 1、研究方法的建立···································································································6 2 、方法学验证·············································································································8 (三)研究结果的分析及质量标准的制定························································9 1、残留溶剂表示方法······························································································9 2、质量标准制定的一般原则及阶段性要求 ··············································10 (四)需要