Study on the Feasibility of Bacterial Endotoxin Test for Hepatocyte Growth-promoting Factors Injection / 中国药房

ABSTRACT

OBJECTIVE:To study the feasibility of bacterial endotoxin test for hepatocyte growth-promoting factors injection as a substitution for pyrogen test METHODS:According to China Pharmacopoeia(second part,2000),interference test was carried on endotoxin detection of hepatocyte growth-promoting factors injection with limulus lysate test agents produced by two different factories RESULTS:There was no interference with the reaction between bacterial endotoxin and limulus lysate test agent in hepatocyte growth-promoting factors injection in 10-fold dilution CONCLUSION:It is feasible to use the gelatine method in bacterial endotoxin test