Pace Analytical Life Sciences (PLS) provides endotoxin testing for the pharmaceutical, biopharmaceutical and medical device industries. This test is also known as the Limulus Amebocyte Lysate, or LAL, test.

Our Process

We follow USP <85> Bacterial Endotoxins Test and EP 2.6.14 as the methods to detect or quantify endotoxins that may be present in or on the sample. The test consists of two different techniques, the gel clot LAL method and the photometric methods. Both techniques require preparatory testing to verify that the sample solution does not inhibit or enhance the detection of endotoxins. Our kinetic endotoxin laboratory personnel are highly trained in both techniques and laboratory procedures to ensure any test glassware or apparatus used is endotoxin free or non-pyrogenic.

The gel clot tests can be a limit test or an actual assay for quantification. Endotoxin testing medical devices using the photometric techniques, turbidimetric, chromagenic gel clot method, can be conducted to an endpoint or used to determine the rate of turbidity development. PLS personnel are available for consultation about test methods, laboratory procedures or challenging products.

We are FDA registered, DEA registered, cGMP compliant and ISO/IEC 17025 accredited.