Program Capabilities

DETL is an ISO/IEC 17025-accredited multi-disciplined drug based testing laboratory. The laboratory has a chemistry and microbiology section, each capable of testing for a wide range of chemical analytes and pathogenic/non-pathogenic microorganisms, respectively. In addition to the scientific analyses performed by the Detroit Laboratory, the laboratory staff also support domestic and foreign pre-approval, surveillance, and for-cause inspections. The Laboratory participates in the Shelf-Life Extension Program (SLEP) and a Collaborative Research and Development Agreement with the US Pharmacopeia (CRADA). The SLEP program focuses on the testing of expiring or expired drug products and is used by the Department of Defense, Strategic National Stockpile, and Veterans Administration to determine if such drugs still fall within the US Pharmacopeia or manufacturer’s specifications. The CRADA program supports the USP reference standard candidate assessments and the modernization of USP monographs. The Detroit Laboratory also participates in the Import Drug Testing Program, Drug Survey Program and supports the testing of dietary supplements in response to health fraud, consumer complaints, and outbreaks and for the purpose of routine surveillance.

Specialized Capabilities

The Detroit Laboratory specializes in the testing of drug samples.

Chemistry

The Chemistry Section has unique expertise in the areas of HPLC/UPLC (high-performance liquid chromatography/ultra performance liquid chromatography) drug analysis, LC/MS (liquid chromatography/mass spectrometry) analysis of dietary supplements, ICP-OES (inductively coupled plasma optical emission spectroscopy) metals analysis of drugs, and dissolution/disintegration drug analysis. The Chemistry Section also specializes in the analysis of drugs associated with consumer complaints.

Microbiology

The Microbiology Section specializes in microbial examination of non-sterile products and in environmental monitoring of pharmaceutical manufacturers of drugs made under controlled environmental conditions. The Microbiology Section pursues an ongoing expansion of its pharmaceutical testing capabilities.