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Our laboratory follows 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 laboratory personnel working in our kinetic endotoxin lab are highly trained in both techniques and in laboratory procedures to assure that 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. Testing for endotoxins using the photometric techniques, turbidimetric, chromagenic gel clot method, can be conducted to an endpoint or used to determine the rate of turbidity development. Pace Analytical Life Science personnel are available for consultation about these test methods, our laboratory procedures or for challenging types of products.

Pace Analytical Life Sciences brings years of experience performing all types of analytical testing on many drug substances, drug products and medical devices. We bring the highest level of quality and attention to detail to our clients to assure that our endotoxin testing services will be successfully executed.

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

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