中国兽药杂志2026，Vol.60Issue(8)：46-52,7.DOI:10.11751/ISSN.1002-1280.2026.8.09
《中国兽药典(第七版)》残留溶剂制修订情况解读
Interpretation of the Revision of Residual Solvents Section in the Chinese Veterinary Pharmacopoeia(7th Edition)
刘艳华 1刘羽 1曹晓钰 1董玲玲 1温芳1
作者信息
- 1. 中国兽医药品监察所(农业农村部兽药评审中心),北京 100081
- 折叠
摘要
Abstract
This article aims to systematically introduce the revision and formulation of the residual solvents section(General Chapter 0861)in the Chinese Veterinary Pharmacopoeia(7th Edition),with a focus on the major changes compared to the 2020 edition.These changes include the introduction of the risk-benefit assessment concept from relevant VICH guidelines,the addition and revision of system suitability test and acceptance criteria,and the inclusion of residual solvent identification.Furthermore,this paper provides an in-depth analysis of the theoretical basis for these revisions,aiming to serve as a reference for work related to the veterinary drug-related field.关键词
《中国兽药典(第七版)》/残留溶剂/制修订/指导原则Key words
Chinese Veterinary Pharmacopoeia(7th Edition)/residual solvents/addition and revision/guidelines分类
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刘艳华,刘羽,曹晓钰,董玲玲,温芳..《中国兽药典(第七版)》残留溶剂制修订情况解读[J].中国兽药杂志,2026,60(8):46-52,7.
