What is the formal method for testing pyrogens?

The formal method for testing pyrogens is through the injection into rabbits, a historically established practice known as the rabbit pyrogen test. This test involves administering a sample to the rabbit and monitoring its body temperature for a defined period. If the sample contains pyrogens, the rabbit will exhibit an elevated body temperature, indicating the presence of these fever-inducing substances. This method is a measure of the overall pyrogenicity of a substance, primarily used in the pharmaceutical industry to ensure safety in injectable drugs and solutions.

While blood tests, serum analysis, and chromatography are important analytical techniques, they do not provide the same direct measurement of pyrogenic response in vivo as the rabbit test does. Blood tests might be useful for detecting specific components or reactions in the bloodstream, but they are not standardized methods specifically for detecting pyrogens. Similarly, serum analysis helps evaluate various biochemical markers in blood but does not directly assess pyrogenicity. Chromatography is a powerful technique for separating and analyzing compounds in a mixture, but it does not specifically test for pyrogens in the manner required for regulatory compliance. Thus, the injection into rabbits remains the formal and traditional method for pyrogen testing.