Investigation of the quality standard of pharmaceutical excipient denatonium benzoate
10.19778/j.chp.2024.06.005
- VernacularTitle:药用辅料苯甲地那铵的质量标准研究
- Author:
Lijuan SHEN
1
;
Lingli QIAN
;
Guoping JIANG
;
Xiaopeng ZHU
;
Lei CHENG
;
Changliang LI
;
Heng LI
Author Information
1. 浙江合糖科技有限公司,浙江金华 321016
- Publication Type:Journal Article
- Keywords:
denatonium benzoate;
bitrex;
bitter agents;
pharmaceutical excipients;
quality standard;
assay
- From:
Drug Standards of China
2024;25(6):560-566
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To revise and enlarge the specification of pharmaceutical excipient denatonium benzoate in the Chinese Pharmacopoeia 2025.Methods:At present,only USP-NF 2023 in domestic and foreign pharmacopoe-ias includes denatonium benzoate.This quality standard is subject to standard research in accordance with USP-NF 2023,the fourth general rules of the Chinese Pharmacopoeia 2020 edition,and other relevant requirements.Results:According to the quality of the product and the actual application in the formulation,the quality standards for the pharmaceutical excipient denatonium benzoate will be studied.At present,the quality standard of denatoni-um benzoate for pharmaceutical excipients has been disclosed.Conclusion:The established standard will fill the domestic gap and provide the quality guarantee for the application of denatonium benzoate in medicines.
