Methodological investigation on bacterial endotoxin in betahistine hydrochloride injection
Objective:Investigation on the quality control method of bacterial endotoxin in betahistine hydrochlo-ride 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.
betahistine hydrochloride injectionbacterial endotoxinlimitsinterference testquality control
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