Bacterial Endotoxin Test for Nicardipine Hydrochloride Glucose Injection / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for the bacterial endotoxin test of nicardipine hydrochloride glucose injection.METHODS:The bacterial endotoxin test was carried out according to the bacterial endotoxin test in the addenda of China Pharmacopeia 2005 edition(second part).RESULTS:Nicardipine hydrochloride glucose injection showed interference on the bacterial endotoxin test when water was taken as solvent.The preliminary interference test and interference test revealed that using thinnerⅠas solvent,the sample injection in over 4-fold dilution had no interference on the bacterial endotoxin test.CONCLUSIONS:It is feasible for bacterial endotoxin test of nicardipine hydrochloride glucose injection be conducted in a limit value of 0.5 EU?mL-1.The bacterial endotoxin text can substitute pyrogen test in the detection of nicardipine hydrochloride glucose injection.