The Detroit Laboratory (DETL) is an ISO/IEC 17025-accredited drug-based testing laboratory. The laboratory is capable of testing for a wide range of chemical analytes and/or active pharmaceutical ingredients (APIs) in various forms, delivery methods and matrices. DETL also supports the Import Drug Testing Program, Drug Survey Program and the testing of dietary supplements in response to health fraud, consumer complaints, public health outbreaks, and for the purpose of routine surveillance. In addition to the scientific analyses performed by DETL, the laboratory staff also support domestic and foreign pre-approval, surveillance, and for-cause inspections. In recent years, DETL has regularly participated in the Method Validation program (MVP) and is the sole analytical testing laboratory for the Bioresearch Monitoring program and the Sunscreen Operations - Laboratory Analysis and Research program. The Laboratory also participates in the Shelf-Life Extension Program (SLEP). 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 (USP) or manufacturer’s specifications.
Instrumental Analysis Capabilities
DETL specializes in the testing of drug samples via various instrumental technologies and methodologies. The laboratory uses a variety of separation and detection techniques to identify targeted and unknown/non-targeted chemical substances for compliance. Technologies such as high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography, gas chromatography (GC), liquid chromatography – mass spectrometry (LC/MS & LC/MS/MS) and gas chromatography – mass spectrometry (GC/MS & GC/MS/MS) are used to verify purity and potency of drugs. Inductively coupled plasma - optical emission spectroscopy, inductively coupled plasma – mass spectrometry for elemental analysis of drugs. Drugs and drug product(s) may also be tested via dissolution/disintegration methodologies to ensure release of APIs upon ingestion as specified by the manufacturer.
The Detroit Laboratory conducts analyses using either established USP monographs, internally developed methodologies under USP and Association of Official Agricultural Chemists guidelines and drug or product manufacturer/vendor provided methods.