Investigation on bacterial endotoxins test of vidarabine monophosphate for injection
Objective:To establish a bacterial endotoxin detection method for vidarabine monophosphate for injection and conduct methodological validation for harmanizing the quality control standard of this product.Methods:According to the Chinese Pharmacopoeia 2020 volume Ⅳ general chapter 1143"Bacterial endotoxin test",the limit of bacterial endotoxin was determined,interference test and endotoxin testing were performed.Results:The bacterial endotoxin test were performed on 25 batches of test samples provided by 15 manufacturers according to the experienced experimented limitation which is the amount of endotoxin in 1 mg of adenosine mono-phosphate should be less than 0.06 EU.All results were found to be in compliance with the specified standards.Conclusion:The established bacterial endotoxin method can be used for quality control of vidarabine monophos-phate for injection.
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