Endotoxin Testing

MDS offers endotoxin assays including turbidimetric plus gel clot and chromogenic methods. All assays are sensitive, reliable, efficient and are conducted in compliance with the U.S. Food and Drug Administration (FDA) and United States Pharmacopeia (USP). Guidelines on end-product tests for endotoxin content are issued by the FDA and the Center for Devices and Radiological Health (CDRH) under 21 CFR Section 10.90 (b).

Test sensitivity depends on the specific lysate used. Turbidimetric testing’s lowest limit of detection (LLD) is 0.005 EU/mL, as compared to 0.03 EU/mL for the gel clot and 0.005 EU/mL for the chromogenic method.

Routine tests are run in duplicate, with inhibition/enhancement testing in triplicate. And the Control Standard Endotoxin (CSE) is tested against the USP Endotoxin Reference Standard (RSE).