Endotoxins are potentially toxic naturally occurring breakdown products of the cell wall of gram negative bacteria. Such material is pyrogenic and can cause fever or acute febrile shock in humans.
Bacterial endotoxin testing (BET) is used to detect and quantify bacterial endotoxins using Limulus Amoebocyte Lysate (LAL) which is an extract of blood cells from the horseshoe crab (limulus polyphemus).
Gel Clot Method Ph. Eur 2.6.14 (Method A) LAL
The gel clot method relies on the reaction between bacterial endotoxin and a specific lysate (LAL) associated with the blood coagulation cascade mechanism of the horseshoe crab limulus polyphemus.
If a gel is formed via a clotting reaction, endotoxin is present and can be quantified by comparison with international reference standards.
Validation of bacterial endotoxin testing will be required in most cases.
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