Datasheet: Contract Test Services

Associates of Cape Cod,® Inc. Contract Test Service (CTS) laboratory specializes in testing for endotoxin and glucan contamination and has the most extensive experience of any endotoxin testing laboratory in the world. CTS performs all methods of the LAL assay: gel-clot, chromogenic, and turbidimetric.

The Limulus Amebocyte Lysate (LAL) test is a method for the detection and quantitation of bacterial endotoxins. LAL reagents are primarily used to test for endotoxins in injectable pharmaceuticals, biological products, and medical devices. They are also used in renal dialysis centers and a wide range of other applications. LAL tests are described in the Bacterial Endotoxins Test chapter in the United States Pharmacopeia (Chapter <85>) and in the equivalent chapters in the European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (General Tests, No. 4.01).

CTS is GMP compliant and ISO registered. CTS is licensed by the DEA as a laboratory capable of handling all controlled drug substances except those included in Schedule I. Endotoxin testing can be performed in accordance with FDA, USP, EP and/or JP, depending on the specifications of the client.