Application of the Kinetic Turbidimetric Limulus Test to the Endotoxin Assay of Levocarnitine Sodium Chloride Injection / 中国药房

ABSTRACT

OBJECTIVE:To apply the kinetic turbidimetric Limulus test to the endotoxin assay of Levocarnitine sodium chloride injection.METHODS:The16-fold dilution of Levocarnitine sodium chloride injection was prepared.The content of bacterial endotoxin in Levocarnitine sodium chloride injection was determined with kinetic turbidimetric Limulus test after screen test and validation test.RESULTS:The16-fold dilution of Levocarnitine sodium chloride injection was effective to e?liminate the interference in Limulus test.The average recovery was in the range of50%～200%.CONCLUSION:The kinetic turbidimetric Limulus test provides a new and quick method for the quantitative determination of bacterial endotoxin in Levo?carnitine sodium chloride injection.