原料中杂质的控制材料.ppt

原料药中杂质的控制The Control of Impurities in Drug Substances 本部分将讨论中国药典对药品杂质分析的新的指导原则，包括ICH 和其他药典的有关要求。 This part of the program will focus on the new guideline of the 2005 Chinese Pharmacopoeia for the analysis of drug impurities,including relevant requirements of ICH and other pharmacopoeias 原料药中杂质的控制The Control of Impurities in Drug Substances 本讨论包括： ICH新原料药中对杂质的指导原则 ICH关于杂质指导原则在国外药典中的引用 中国药典(2005)药品杂质分析指导原则 原料药中杂质的控制The Control of Impurities in Drug Substances 虽然ICH指导原则是对申报新化学药和新生物制品的技术要求，但经ICH三方成员国制药工业部门和药品管理部门的协调，其原则切实可行，在保证药品安全有效，药品的生产按GMP的要求，起一定作用，逐步为各国采用。不仅作为申报新药的要求，有的还作为修订药典正文的要求。 ICH新原料药中的杂质指导原则ICH Guideline on Impurities in New Drug Substances 文件Q3A（R）为未曾在ICH 三方注册过的化学合成新原料药申报时关于杂质的指导原则 This document is intended to provide guidance for registration application on content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state. ICH新原料药中的杂质指导原则ICH Guideline on Impurities in New Drug Substances Q3A（R）杂质分类 Classification of Impurities 有机杂质 Organic Impurities 无机杂质 Inorganic Impurities 残留溶剂 Residual solvents ICH新原料药中的杂质指导原则ICH Guideline on Impurities in New Drug Substances 其中有机杂质包括起始原料、副产物、中间体、降解产物、试剂、配位体、催化剂。可以是经鉴定或未鉴定的 The organic impurities include starting materials,by-products,intermediates, Degradation products, reagents, ligands and catalysts( identified or unidentified) ICH新原料药中的杂质指导原则ICH Guideline on Impurities in New Drug Substances Q3A (R) 关于有机杂质的报告和控制中几点说明 Rational for the reporting and control of organic impurities ICH新原料药中的杂质指导原则ICH Guideline on Impurities in New Drug Substances 为便于理解，先介绍ICH杂质指导原则中的几个术语： Reporting Threshold: A limit above () which an impurity should be reported. 报告限：系指一个限度，大于该限度的杂质，应该（在申报资料中）报告 ICH新原料药中的杂质指导原则ICH Guideline on Impurities in New Drug Substances Identification Threshold: A limit above () which an impurity should be identified. 鉴定限：系指一个限度，大于该限度的杂质，应作鉴定 ICH新原料药中的杂质指导原则ICH Guideline on Impurities in New Drug Substances Qual