Inhibition/enhancement test

A bacterial endotoxin test suitability study proving that the product does not interfere with detection of endotoxin. The product, at the intended dilution, is spiked with known amounts of endotoxin. For the gel clot method, the endpoint must be between 0.5λ and 2λ; for photometric methods, recovery must be 50–200%. If the product inhibits or enhances, it is diluted within the maximum valid dilution or treated, and the test is repeated.