LAL (Lysate of Limulus Amaebocytes) test

Regulatory reference: USP85.
Claim: Absence of bacterial endotoxins
Application field: Medical devices: raw ingredients and finished products.
Description of the test: Lysate of limulus amaebocytes (LAL) is an acqueous extract obtained by Limulus polyphemus amaebocytes. The LAL reacts strongly to endotoxins in Gram-negative bacterial membranes (lypopolysacchartides), resulting in coagulation. This property is exploited in the LAL test to detect endotoxins.
Posted in Raw materials for medical devices, Absence of bacterial endotoxins, Claim for medical devices