Methodological investigation on bacterial endotoxin in betahistine hydrochloride injection
10.19778/j.chp.2024.01.014
- VernacularTitle:盐酸倍他司汀注射液细菌内毒素方法学研究
- Author:
HAO Gang
;
ZHANG Lifang
;
WU Xing
;
YAN Hao
;
ZHAO Yating
;
HAN Feng
- Publication Type:Journal Article
- Keywords:
betahistine hydrochloride injection;
bacterial endotoxin;
limits;
interference test;
quality control
- From:
Drug Standards of China
2024;25(1):082-089
- CountryChina
- Language:Chinese
-
Abstract:
Objective: Investigation on the quality control method of bacterial endotoxin in betahistine hydrochloride injection.
Methods: The method of bacterial endotoxin gel test of 23 batches of betahistine hydrochloride injection from 5 manufacturers was studied.
Results: The limit value of endotoxin in this product was 3 EU·mg-1, which was suitable for the bacterial endotoxin test of China Pharmacopoeia 2020.
Conclusion: The quality of betahistine hydrochloride injection can be controlled by bacterial endotoxin test, and the limit of bacterial endotoxin can be set as follows: the content of endotoxin in every 1mg of betahistine hydrochloride should not exceed 3 EU.
- Full text:202408101323371291020240214.pdf
