Study of Bacterial Endotoxin Test on 84 Drugs for Injection

OBJECTIVE To screen the drug for injection with Pyrogen test in Ch.P(2000)VolⅡ,to evaluate the possibility for the replacement with bacterial endotoxin test;and to investigate the methodology of the bacterial endotoxin test for all kinds of injections required for Pyrogen test in Ch.P(2000) Vol Ⅱ.METHODS Interference tests were done on each sample of injections by using bacterial endotoxin gel-method.The samples were provided by the collaboration of Pharmacology Divisions of Institute for Drug Control in 28 provinces or cities.RESULTS Determined the no interference concentration or the minimum no interference dilution of each drug and whether the drug is valid for bacterial endotoxin test.CONCLUSION 84 drugs for injection are valid for bacterial endotoxin test,and 16 drugs for injection are not suitable for bacterial endotoxin test.