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. |