Chromak Research is an expertise in microbiology testing & pharmaceutical testing, providing Endotoxin Testing services to detect and quantify gram-negative bacterial endotoxins by gel-clot technique. The gel-clot technique is used for detecting endotoxins based on clotting of the lysate reagent in the presence of endotoxin. This test is also known as the Limulus Amoebocyte Lysate (LAL) test or the “pyrogen” test due to the ability of endotoxins to cause fever in mammals. It is important that the USP <85> BET test not be confused with the rabbit pyrogen test, USP <151>. Endotoxin testing can be performed on raw and in-process materials as well as for the final release of pharmaceutical and medical device products.
To ensure both the precision and validity of the test, The USP <85> preparatory test is used to confirm the labeled lysate sensitivity and any interfering factors.