AN OVERVIEW OF LIMULUS AMOEBOCYTE LYSATE (LAL) TEST

Abstract

Limulus Amoebocyte Lysate (LAL) test is in vitro test to detect and measure bacterial endotoxins. It is the most critical quality control test required by FDA for all parenteral drugs in their final stages of formulation. Endotoxins are products of metabolism associated with outer membrane of gram negative bacteria especially Pseudomonas, E. coli and Serratia and are most significant source of pyrogens. They are ubiquitous and cause profound physiological changes when administered parenterally. Also they play an important role in occurrence and development of many diseases. Their detection is very important in manufacturing of parental drugs, biological products and medical devices. There is specification of endotoxin limit provided in monograph of each pharmacopoeia. The convential rabbit test has several disadvantages. LAL test is recently developed quantitative test has overcome rabbit test due to many reasons. The article will discuss about the basic principle, development, different methods, comparison with rabbit test and applications of the test.