EMA残留溶剂指南附录
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Annexes to:
CPMP/ICH/283/95 Impurities: Guideline for residual solvents
&
CVMP/VICH/502/99 Guideline on impurities: residual Solvents
EMA关于残留溶剂指南CPMP/ICH/283/95 杂质-残留溶剂指南和CVMP/VICH/502/99 杂质指南-残留溶剂的附录
Annex I: specifications for class 1 and class 2 residual solvents in active Substances
附录I：API中I类和II类残留溶剂质量标准
Annex II: residues of solvents used in the manufacture of finished products
附录II：制剂生产中使用溶剂的残留
Discussion at Quality Working Party 质量工作组讨论会议January 2003 to June 2004 2003.01~2004.06
Adoption by CVMP CVMP 采纳July 2004 2004.07
Adoption by CHMP CHMP 采纳July 2004 2004.07
Date for coming into operation 生效时间January 2005 2005.01
Rev. 01 Adoption by Quality Working Party 质量工作组采纳的01版本22 November 2012
2012.11.22
Rev. 01 Adoption by CVMP CVMP采纳的01版本7 February 2013 2013.02.07
Rev. 01 Adoption by CHMP CHMP采纳的01版本11 February 2013 2013.02.11
Rev. 01 Date for coming into operation 01版本生效1 March 2013 2013.03.01
Introduction
前言
The two (V)ICH residual solvents guidelines, ICH Q3C Impurities: Guideline for residual solvents (CPMP/ICH/283/95) and VICH GL18 Guideline on impurities: residual solvents in new veterinary medicinal products, active substances and excipients (CVMP/VICH/502/99), have been in operation for several years, since March 1998 and June 2001 respectively.
虽然ICH颁布的ICH Q3C 杂质: 残留溶剂指导原则 (CPMP/ICH/283/95) 和VICH GL18 杂质指导原则：兽用药、API和辅料(CVMP/VICH/502/99)中的残留溶剂这两个关于残留溶剂的指南分别从1998.03和2001.06就开始被采纳应用。
However, it has become evident that further clarification was required regarding the specifications for Class 1 and class 2 residual solvents in active substances.
但是从应用的实际情况来看，EMA觉得需要对API中I类和II类残留溶剂质量标准的问题进行澄清。
A clear interpretation of the issues regarding residues of solvents used in the manufacture of finished medicinal products, both human and veterinary, was also required.
EMA同时也认为需要对人用药和兽用药生产中的溶剂残留问题进行清楚的解释和说明。
Annex I: Specifications for class 1 and class 2 residual solvents in active substances
附录I：API中I类和II类残留溶剂质量标准
Specifications for class 1 solvents
I类溶剂质量标准
In both the ICH and VICH guidelines on impurities: residual solvents it is stated that “solvents in class 1 should not be employed in the manufacture of drug/active substances, excipients, and drug/veterinary medicinal products because of their unacceptable toxicity or their deleterious environmental effect. However, if their use is unavoidable in order to produce a drug/veterinary medicinal product with a significant therapeutic advance, then their levels should be restricted as shown…….., unless otherwise justified”.
因为I类溶剂的巨大的毒性或者对环境的危害性的原因，因此在ICH和VICH关于杂质-残留溶剂的指南中已经明确说明了