Study on the standard of histidine hydrochloride as a pharmaceutical excipient in Chinese Pharmacopoeia 2025 Edition
10.19778/j.chp.2025.05.006
- VernacularTitle:2025年版《中国药典》药用辅料盐酸组氨酸标准研究
- Author:
Lingbo LIU
1
;
Zhihao LIANG
;
Zhen MA
;
Xiangdian QIU
;
Yanyun LIU
;
Hong LIU
Author Information
1. 西南大学药学院,重庆 400715
- Publication Type:Journal Article
- Keywords:
histidine hydrochloride;
Chinese Pharmacopoeia;
medicinal excipients;
quality standards;
other amino acids
- From:
Drug Standards of China
2025;26(5):482-487
- CountryChina
- Language:Chinese
-
Abstract:
By comparing the quality standards of histidine hydrochloride in pharmacopoeias of various countries,the optimization and improvement projects for the quality standards of histidine hydrochloride for pharmaceutical ex-cipients in the 2025 edition of the Chinese Pharmacopoeia are clarified,and the description of this standard is standardized according to the requirements of the"Detailed Rules for the Compilation of National Pharmaceutical excipient Standards".This article aims to clarify the key research content of the quality standard formulation process for medicinal excipient histidine hydrochloride,to provide a deeper understanding of this standard for drug regulatory agencies,production enterprises,and other practitioners.
