What is the Origin of Bacterial Endotoxins Test?

The origin of this specific test lies in the unique biochemical properties of the Limulus polyphemus (horseshoe crab) amebocyte lysate, which clots upon exposure to minute amounts of endotoxin. Regulatory pharmacopeias worldwide have adopted the LAL test as the standard method for verifying the absence of bacterial contamination in sterile drugs.

What is the Mechanism of Bacterial Endotoxins Test?

The LAL reagent contains a cascade of coagulation proteins that are exquisitely sensitive to the presence of bacterial endotoxin. Upon contact, the cascade is activated, resulting in either a measurable gel clot, a chromogenic color change, or an increase in turbidity. This precise and rapid biochemical reaction allows compounding pharmacies and manufacturers to accurately confirm that their hormonal preparations meet stringent regulatory safety limits before being administered to patients.

Bacterial Endotoxins Test

Meaning

The Bacterial Endotoxins Test, widely recognized as the LAL test, is a mandatory, highly sensitive quality control assay used to detect and quantify lipopolysaccharide (LPS), a potent pyrogenic contaminant derived from the cell walls of Gram-negative bacteria. The presence of endotoxins in injectable or implantable hormonal preparations poses a serious clinical risk, potentially inducing a severe febrile reaction or septic shock in the patient. This test is essential for ensuring the non-pyrogenicity and safety of all parenteral pharmaceutical products.