Abstract:

OBJECTIVE: To establish a medthod for the bacterial endotoxin test of calcium gluconate injection.METHODS:The bacterial endotoxin test was carried out according to the bacterial endotoxin test in the addenda of China Pharmacopeia 2005 edition（the first part）.RESULTS: Calcium gluconate injectionshowed interference on the bacterial endotoxin test when water taken as solvent.The preliminary interference test and interference test revealed that using thinner I as solvent,the sample injection in over 2-fold dilution had no interference on the bacterial endotoxin test.CONCLUSIONS：It is feasible for bacterial endotoxin test of calcium gluconate injection be conducted in a limit value of 2.5EU/ml.The bacterial endotoxin test can substitute pyrogen test in the detection of calcium gluconate injection.