ABSTRACT
Limulus amebocyte lysate (LAL) has had a tremendous impact since its introduction in the early 1970s. It is now used to quantify endotoxin in parenteral drugs including oligonucleotides and medical devices. It is used in research on a wide variety of disciplines, from clinical to environmental applications. LAL is used in basic research on gram-negative bacterial wall structure, lipopolysaccharide (LPS) biosynthesis, and bioactivity. In 1983, the LAL test for gram-negative bacterial endotoxin became the ‰rst in vitro test to replace an in vivo test for a toxic substance when the U.S. Pharmacopeia (USP) began replacing the pyrogen test (rabbit fever test) with the bacterial endotoxins test (BET) in the water and radiopharmaceutical monographs. Today, the majority of the monographs specify the LAL test.
