Analysis of the Rules for Compiling National Standards for Pharmaceutical Excipients
10.19778/j.chp.2025.02.001
- VernacularTitle:国家药用辅料标准编写细则解析
- Author:
Meifang LI
1
;
Lei CHEN
;
Yan WU
;
Zili XIE
;
Luxia ZHENG
;
Yanming LIU
;
Hong DAI
Author Information
1. 深圳市药品检验研究院,广东 深圳 518057
- Publication Type:Journal Article
- Keywords:
Chinese Pharmacopoeia;
pharmaceutical excipients;
detailed rules for compilation;
analysis
- From:
Drug Standards of China
2025;26(2):117-121
- CountryChina
- Language:Chinese
-
Abstract:
Asthe standard for drafting standards,the Rules for Compiling National Standards for Pharmaceutical Excipients was first issued in the 2020 edition and then revised and re-issued in 2025.It has become an important technical specification for the pharmaceutical excipients standards in the Chinese Pharmacopoeia and for the phar-maceutical excipients standards formulated by pharmaceutical companies for associated review and approval.This article focuses on introducing the working background,main framework and main characteristics of the Rules for Compiling National Standards for Pharmaceutical Excipients,aiming to help the drafters,reviewers and implement-ers of pharmaceutical excipients standards better understand and master them,so as to further improve the standard-ization of writing pharmaceutical excipients standards and enhance the level of standards formulation and revision of pharmaceutical excipients.
