INTRODUCTION

The pyrogen test is designed to limit to an acceptable level the risks of febrile reaction in the patient to the administration, by injection, of the product concerned. The test involves measuring the rise in temperature of rabbits following the intravenous injection of a test solution and is designed for products that can be tolerated by the test rabbit in a dose not to exceed 10 mL/kg injected intravenously within a period of NMT 10 min. For products that require preliminary preparation or are subject to special conditions of administration, follow the additional directions given in the individual monograph or, in the case of antibiotics or biologics, the additional directions given in the federal regulations (see Biologics 〈1041〉). A validated, equivalent in vitro pyrogen or bacterial endotoxin test may be used in place of the in vivo rabbit pyrogen test, where appropriate.