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Endotoxins
are defined as toxins associated with the outer membranes of certain 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 only 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.
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 from 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.
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