ICH Q3C(R8)残留溶剂指南20200327(中英文对照版)草案.pdf

INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE ICH 协调指南 IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS Q3C(R8) 杂质：残留溶剂指南Q3C(R8) PDE FOR 2-METHYLTETRAHYDROFURAN, CYCLOPENTYL METHYL ETHER, AND TERTIARY-BUTYL ALCOHOL 2- 甲基四氢呋喃，环戊基甲醚和叔丁醇的PDE 值 Draft version Endorsed on 25 March 2020 2020 年3 月25 日通过草案 Currently under public consultation 目前公开征求意见 Note : This document contains only the PDE levels for three solvents: 2-methyltetrahydrofuran, cyclopentylmethylether and tert-butanol that were agreed to be included in the ICH Q3C(R8) revision. Further to reaching Step 4, these PDEs would be integrated into a complete Q3C(R8) Guideline document. 注：本文仅包括了2- 甲基四氢呋喃，环戊基甲醚和叔丁醇3 种溶剂的PDE 水平，已由ICH 同意放入ICH Q3C(R8)修订版中。在到达第4 阶段时，会将这些PDE 内容整合至完整的Q3C （R8）指南文件中。 At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures. ICH 进程第2 阶段中，ICH 相关专家工作组已通过草案或指南，由ICH 组委会转给ICH 地区药监机构在 内部和外部根据国家或地区程序征求意见。 IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS 杂质：残留溶剂指南Q3C(R8) PDE FOR 2-METHYLTETRAHYDROFURAN (2-MTHF), CYCLOPENTYL METHYL ETHER (CPME), AND TERTIARY BUTYL ALCOHOL (TBA) 2- 甲基四氢呋喃（2-MTHF），环戊基甲醚（CPME ）和叔丁醇（TBA ）的PDE 值 Document History 文件历史 Code 编号 H