Whitepaper: Bacterial Endotoxin Kinetic Turbidimetric Interference Control Validation (Endotoxin Inhibition)

Assessing endotoxin levels in pharmaceutical drugs and medical devices is essential to prevent pyrogenic responses and septic shock in patients. This necessity underscores the importance of performing endotoxin tests for injectable products and medical devices. The presence of endotoxins in the human body can lead to severe adverse effects, including high fever, vasodilation, diarrhea, and fetal shock syndrome. Therefore, rigorous testing for endotoxins is critical to ensuring the safety and efficacy of these products.

The Bacterial Endotoxin Test (BET) is a test to detect and quantify endotoxin from gram-negative bacteria using limulus amoebocyte lysate (LAL) extracted from horseshoe crab’s blood. The kinetic turbidimetric endotoxin technique is based on development of turbidity after cleavage of an endogenous substrate. The technique is conducted by mixing LAL with test sample solution and recording the mixture’s absorbance at a certain wavelength. However, certain substances present in a sample may cause endotoxin inhibitory effects which causes the endotoxin result to be lower than it should be.

Therefore, this paper will investigate the effect of endotoxin inhibition on the results and the usage of a buffer to rectify the problem.

Check out our new whitepaper produced by SaniChem Resources Microbiology Department on determining whether Mg-Buffer can improve the recovery percentage of endotoxin when samples have endotoxin-inhibiting effects.

Bacterial Endotoxin Kinetic Turbidimetric Interference Control Validation (Endotoxin Inhib.

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