Quality Analysis of Betahistine Hydrochloride and Sodium Chloride Injection
In this paper,44 batches of betahistine hydrochloride and sodium chloride injection were tested according to the legal standards.At the same time,the related substances and the new method for the content of betahistine hydrochloride were studied,and the osmolality was detected.According to the legal standard,the qualified rate of 44 batches of betahistine hydrochloride sodium chloride injection was 100%.The impurities 2-pyridine ethanol and 2-vinyl pyridine were detected in the exploratory study of relevant substances,and the content of 2-vinyl pyridine was high.The results showed that the overall quality of betahistine hydrochloride sodium chloride injection is good,the production process needs to be further improved and the test standard needs to be improved.
betahistine hydrochloride and sodium chloride Injectionquality analysislegal standardsexploratory research
NETL
NSTL
万方数据
维普
