Program Capabilities

PHIL is an ISO/IEC 17025-accredited drug based testing laboratory. In addition to the scientific analyses performed by the PHL, 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

PHIL Pharmaceutical Laboratory also has the unique capability of testing pressurized topical aerosols, metered-dose inhalers, and propellant-free dry-powder inhalers used to aerosolize, or to aerosolize and meter, doses of powder for inhalation. This includes metered-dose inhalers (breath-actuated or dose-metering nebulizers) with inhalants formulated as suspensions or solutions of active drug in propellants and dry-powder inhalers marketed as single- or multi-dose units. The drug analysis performed in PHL is heavily focused on high-performance liquid chromatography (HPLC). This is the largest concentration of major instrumentation in the laboratory. PHIL has recently increased its mass spectroscopy capabilities to allow for the inclusion of screening for toxins and poisons, and PDE 5 inhibitors using the LC/MS and screening for weight-loss drugs in dietary supplements using GC/MS.