Bacterial Endotoxin Testing
Bacterial endotoxin is a complex of lipopolysaccharide (LPS) and protein in the cell
wall of gram-negative bacteria, which is released when the bacteria die or autolysis. A
large amount of endotoxin enters the bloodstream and causes a febrile reaction - a
"pyrogenic reaction". If endotoxin enters and collects in the blood in large quantities
and exceeds the clearance capacity of the body's self-defense system, endotoxemia of
different degrees may result. Therefore, biological products, pharmaceuticals for
injection, chemicals, radiopharmaceuticals, antibiotics, vaccines, dialysis solutions
and other preparations, as well as medical devices (such as disposable syringes and
implantable biological materials) must be tested for bacterial endotoxin before use.
Fig.1 3D image of bacterial endotoxin
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Different samples need to find the corresponding interfering factors, find the type of
interfering effect, find the method to eliminate the interference, go through method
validation, determine the method, and then perform daily testing. To ensure the
quality of your injectable drug formulations, medical devices, raw materials,
excipients, water, water for injection, and APIs, CD Formulation's experts offer
endotoxin detection and control testing. Your testing is performed for USP <85>
bacterial endotoxin testing and USP <161> infusion and infusion components.
