Limulus amebocyte lysate (LAL) is an aqueous extract of blood cells (amoebocytes) from the Atlantic horseshoe crab Limulus polyphemus. LAL reagents are primarily used to test for endotoxins in injectable pharmaceuticals, biological products, and medical devices. They are also used in renal dialysis centers and a wide range of other applications. LAL tests are described in the Bacterial Endotoxins Test chapter in the United States Pharmacopeia (Chapter <85>) and in the equivalent chapters in the European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (General Tests, No. 4.01).
LAL reacts with bacterial endotoxin lipopolysaccharide (LPS), which is a membrane component of gram-negative bacteria. This reaction is the basis of the LAL test, which is widely used for the detection and quantification of bacterial endotoxins.
There are three main types of quantitative LAL tests that are widely used for BET:
These assays can not only determine the presence/absence of endotoxin in a sample, but also reveal the quantity of endotoxin present. This data facilitates compliance to quality control (QC) testing and data integrity standards for a wide range of applications in pharmaceutical drug development and manufacturing.
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