Determining the potential presence of pyrogens in your product in order to limit the risk of febrile reaction in the patient.

Minimizing the febrile response in patients.

The purpose of the study is to determine the potential presence of pyrogens in extracts of solid materials in order to limit to an acceptable level the risks of febrile reaction following administration of the product to the patient.  The study involves measuring the rise in temperature of New Zealand White rabbits following the intravenous injection of a test article extract. It is designed for products that can be tolerated by the test rabbit in a dose not to exceed 10 mL per kg, administered within a period of not more than 10 minutes.

Testing categories and specifications

CategoryTest NameSample NeededTurn-Around Time
PyrogenicityMaterial-Mediated Rabbit-Pyrogen Assay600 cm² < 0.5 mm thick, 300 cm² ≥ 0.5 mm thick, or 20 g3-4 weeks