Investigation on bacterial endotoxin in nafamostat mesilate for injection by kinetic chromogenic assay
Objective:To establish a bacterial endotoxin test method for nafamostat mesilate for injection.Methods:The interference test of the bacterial endotoxin test method-kinetic chromogenic assay was carried out according to the Chinese Pharmacopoeia 2020 Volume Ⅳ general chapter 1143.Results:The interference effect of naphtholimus mesylate can be effectively eliminated by treating the test solution with an alkaline regulator for a certain period of time and diluting it.Conclusion:The bacteria endotoxin test-kinetic chromogenic assay for nafa-mostat mesilate for injection is applicable.
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