Investigation on bacterial endotoxins test of terbutaline sulfate active pharmaceutical gredient
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.
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维普
