Endotoxin Detection Assays and Kits are used to detect the presence of bacterial contaminants known as endotoxins. Endotoxins are lipopolysaccharides found in cell walls of Gram-negative bacteria. Endotoxins present in a pharmaceutical product can induce inflammation and fever, and in the most extreme cases, reaction to endotoxins can lead to anaphylactic shock and death.
Preventing outbreaks of illnesses caused by these pathogens is of critical importance to drug manufacturers. Both the FDA and USP <797> set limits on the amount of endotoxins allowed in pharmaceutical products. Each drug has its own acceptable level of these pathogens; determined by human tolerance and the drug delivery route. .