Study of bacterial endotoxin test on 84 drugs for injection

OBJECTIVE: To screen the drug for injection with Pyrogen test in Ch. P(2000) Vol II, 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.