An Improved In Vitro Pyrogen Test To Detect The Presence of Endotoxin Containing Bacteria Using Limulus Amoebocyte Lysate Assay From Pharmaceutical Raw Product

Abstract

Most of the environmental organism possess endotoxin which presence indicates the organisms are much lethal and for the purposes bacteriological quality of pharmaceutical raw products is much important .In these current study, 2 raw materials out of 10 were found to containing pathogenic bacteria Escherichia coli and Pseudomonas species in the culture medium, that indicates the raw materials were contaminated with the deadly organism. These two raw materials checked for the presence of Endotoxin and both provided positive gel clot by Limulas amoebocyte lysate (LAL) assay .Quality maintenance and assurance is the essential need of Drug preparation in pharmaceutical sector .The result ensure that Pharmaceutical industry should need to follow GMP and HACCP to minimize the contamination for improving the biological safety of the product in a cost-effective manner. Key Word: Limulas amoebocyte lysate (LAL) assay, Gram negative bacteria, endotoxin .