2025年版《中国药典》制药用水标准体系概况  

The introduction on the standards system of water for pharmaceutical purposes in the Chinese Pharmacopoeia 2025 Edition

作　　者：陈蕾[1] 王琳 张功臣 马仕洪[4] 张军[1] 马双成 CHEN Lei;WANG Lin;ZHANG Gongchen;MA Shihong;ZHANG Jun;MA Shuangcheng(Chinese Pharmacopoeia Commission,State Key Laboratory of Drug Regulatory Science,Beijing 100061,China;Beijing Institute of Drug Testing,Beijing 100085,China;Shanghai Yikang Technology Co.,Ltd,Shanghai 201612,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]国家药典委员会,药品监管科学全国重点实验室,北京100061 [2]北京市药品检验研究院,北京102206 [3]上海谊康科技有限公司,上海201612 [4]中国食品药品检定研究院,北京100050

出　　处：《中国药品标准》2025年第1期77-82,共6页Drug Standards of China

基　　金：国家药品标准提高课题(2022Y29、2016年第447号等)。

摘　　要：按照2025年版《中国药典》编制大纲确定的工作目标和任务,2025年版《中国药典》对制药用水的标准体系进行了系统完善。本文着重介绍了2025年版《中国药典》制药用水标准体系的工作背景、总体思路、工作方式、标准框架、重点内容说明和意义等,以期对2025年版《中国药典》的使用者正确理解、执行或运用药典标准有所帮助。According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition,the standards system of Water for Pharmaceutical Purposes has been perfected.This article focuses on the Work Background,Overall Approach,Work Methodology,Standard Framework,Key Content and Significance on the standards system of Water for Pharmaceutical Purposes in the Chinese Pharmacopoeia 2025,which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.

关 键 词：中国药典 制药用水 标准体系 

分 类 号：R921.2[医药卫生—药学]