A comparative study between pyrogen and limulus amebocyte lysate-dependant(LAL) tests for determination of endotoxin level in some biological products

Abstract

Endotoxins are heat-stable lipopolysaccharide present in the outer membrane of the cell envelope of Gram negative bacteria and considered as the major contributors to the pyrogenic response of the contaminated pharmaceutical products and consequently influence public health. The aim of this study was to compare in vivo rabbit pyrogen test (RPT) with in vitro Limulus Amebocyte Lysate (LAL) test for the lipopolysaccharide (endotoxin) detection and determination of the product safety for human use. The study was conducted in order to identify the pros and cons of both methods as well as their interchangeability for the endotoxin detection in the biological products. LAL test could be used successfully and the results revealed that the endotoxin levels of 12 out of 13 tested preparations were equal to half or even less the acceptable endotoxin limit for human use.