Investigation on bacterial endotoxins test of terbutaline sulfate active pharmaceutical gredient
10.19778/j.chp.2024.04.009
- VernacularTitle:硫酸特布他林原料药细菌内毒素检查方法学研究
- Author:
Xinyu WANG
1
;
Zhenhua LIU
;
Haixia LU
;
Haofang ZHANG
Author Information
1. 吉林省药品检验研究院,长春 130033
- Keywords:
terbutaline sulfate;
active pharmaceutical ingredient;
bacterial endotoxins test;
interference test;
gel method
- From:
Drug Standards of China
2024;25(4):376-379
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a method for the detection of bacterial endotoxin in terbutaline sulfate active pharmaceutical ingredients(API).Methods:The method of terbutaline sulfate was verified by gel method,and interference test and bacterial endotoxin test were performed on three batches of samples.Results:The limit for terbutaline sulfate API that can be used for bacterial endotoxin test was set as"the amount of endotoxin contained in terbutaline sulfate should be less than 0.50 EU per 1 mg".Conclusion:Limulus gel method can be used to detect bacterial endotoxin of terbutaline sulfate API.
