Introduction on the standard of pharmaceutical excipients in the first supplement of the Chinese Pharmacopoeia 2020
10.19778/j.chp.2024.02.010
- VernacularTitle:《中国药典》2020年版第一增补本药用辅料标准解读
- Author:
Lei CHEN
1
;
Ying CHEN
;
Yanming LIU
;
Yaozuo YUAN
;
Hong DAI
;
Jiasheng TU
Author Information
1. 国家药典委员会,北京 100061
- Keywords:
Chinese Pharmacopoeia 2020;
The first supplement;
pharmaceutical excipients;
standards;
introduction
- From:
Drug Standards of China
2024;25(2):168-175
- CountryChina
- Language:Chinese
-
Abstract:
The first supplement of the Pharmacopoeia of the People's Republic of China 2020 Edition will be imple-mented on March 12,2024.It plays an important role in connecting link between the preceding and the following.Among them,11 new pharmaceutical excipients monographs have been added and 46 monographs have been revised.This formulation and revision of pharmaceutical excipients standards are based on the concept of risk man-agement and the full lifecycle management and focuse on ensuring the clinical safety and effectiveness of drugs,the evaluation of critical quality attributes on pharmaceutical excipients is highlighted in the standard-making process,and functional-related characteristics(FRCs)and safety indicators are included.Moreover,the excipient standards have emphasized the concept of international pharmacopeia harmonization and green environmental protection and strengthened the standardization and operability.This article focuses on the general framework and the main charac-teristics of the standards of pharmaceutical excipients in the first supplement of the Chinese Pharmacopoeia 2020,which can contribute to accurately understand and utilize the standards in the Chinese Pharmacopoeia.
