The Bacterial Endotoxin Test (BET) is a test to quantify Endotoxin from ‘Gram-negative bacteria using ‘amoebocyte lysate’ extracted from ‘Limulus polyphemus or Tachypleus tridentatus’ i.e. horseshoe crab. Three techniques are used for the confirmation of endotoxins, those are: the gel-clot technique, the turbidimetric technique, and the chromogenic technique. Endotoxins are toxic complexes which is invariably associated with the cell-wall of the Gram-negative bacteria irrespective of bacterial pathogenicity. Endotoxins are rarely fatal, but they cause fever and hence Endotoxin carrying bacteria are known as ‘Pyrogen’. The test can be done by any of these three techniques. Among all, the gel-clot method is chosen to be superior. The test is carried out in a manner to avoid endotoxins contamination. Mostly bacterial Endotoxin test are performed for the inject-able pharmaceutical products, e.g. SWFI (Sterile Water for Injection), Normal Saline (Sodium Chloride Sterile) and other injections like Amikacin sulphate, Ascorbic acid, etc. Endotoxin had been authenticated as inflammatory agent, onset clinical diabetes, obesity, nausea, vomiting, diarrhea, fever, etc. Endotoxins are thus very necessary to get removed out from the inject-able pharmaceutical products.
Endotoxin, Gram-negative bacteria, Amoebocyte lysate, Lysate validation, Lysate reconstitution, Maximum Valid Dilution, Endotoxin Limit, Gel-clot technique
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