USP <85> Bacterial Endotoxin Test. Turbidimetric Bacterial Endotoxin test system. Standard test are configured to compensate for beta-glucan interferences. All tests include a positive endotoxin spike to detect endotoxin inhibition/enhancement effects.
Endotoxins are defined as cell wall material from gram-negative bacteria. Upon injection, endotoxins may cause a state of shock, fever, altered resistance to bacterial infection, as well as other biologic effects. Endotoxins are part of a larger group known as pyrogens. Pyrogens are fever-inducing agents produced by bacteria, molds, viruses, and yeasts.
At Eagle Analytical Services, we use the USP <85> turbidimetric method to test for bacterial endotoxins in compounded medications. Quantities of endotoxin are expressed in endotoxin units per milliliter (EU/mL). An endotoxin unit is a standardized unit of biologic activity, measured with the LAL test and calibrated to the USP/FDA reference endotoxin; it is equal to the international unit (IU) of activity used by the World Health Organization (WHO).
Eagle Analytical Services utilizes the top-of-the-line Pyros Kinetix™ Incubating Kinetic Tube Reader, manufactured by Associates of Cape Cod (ACC). As the first company to be licensed by the FDA, ACC has continued to be a market leader in innovation and technology in the endotoxin testing industry. The Pyros Kinetix is based on the principle that in the presence of endotoxin, LAL becomes turbid. The Pyros Kinetix is an extremely sensitive piece of equipment, and gives Eagle Analytical Services the ability to detect endotoxin levels down to 0.001 EU/mL. Eagle Analytical Services also runs an inhibition/enhancement test on every sample we analyze.