Test Methods
Gel-clot
The original LAL assay and the method of reference in most reference manuals (maximum sensitivity 0.03 EU/mL).
Turbidimetric
The most sensitive endotoxin test available in the industry (maximum sensitivity 0.001 EU/mL).
Chromogenic
Color formation is used to quantitate endotoxin (maximum sensitivity 0.001 EU/mL) and glucans.
Test Types
Characterization test
This test is used to quantify the amount of endotoxin or glucan present in a test sample. A series of dilutions are made in order to find a valid testing dilution which can be used to calculate the endotoxin or glucan concentration of a sample.
Validation test
(USP/EP inhibition or enhancement test)
This test is used to demonstrate that the product does not interfere with the LAL assay. This test is performed at a dilution that is at or below the Maximum Valid Dilution (MVD) for that product. The MVD is determined by the endotoxin limit for the product. Validation is required for all finished products that are parenteral or intrathecal. The test method should be validated using three lots of the finished product before the Release Test is used to release product. The procedure is also used to demonstrate that the assay is valid when used to test raw or in-process materials.
Release test
This test is used to release finished products once the assay has been validated. The test is run at the same dilution used in the Validation. The Release test is also used to release raw materials, in-process materials, and other non-finished goods.