Test for Bacterial Endotoxins in Cefalotin Sodium for Injection by Gel Clot / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for test of bacterial endotoxin on cefalotin sodium for injection by gel clot.METHODS:Cefalotin sodium for injection was diluted in water for determination of bacterial endotoxin and allocated to sample negative and sample positive controls to determine its maximum noninterference concentration;Then bacterial endotoxins were diluted into solutions of different concentrations with the test solutions,and interference test was carried out by using tachy?pleus amebocyte lysate sensitivity compound nucleus.RESULTS:The maximum noninterference concentration of cefalotin sodium for injection was6.68mg/ml;And cefalotin sodium at the concentration of1.67mg/ml did not interfere with the test for bacterial endotoxins.CONCLUSION:The present method can replace pyrogen test with rabbit for examination of bacterial endotoxin in cefalotin sodium for injection.