Program Capabilities

The Philadelphia Laboratory (PHIL) is an ISO/IEC 17025-accredited drug based testing laboratory.  The Laboratory participates in the Shelf-Life Extension Program (SLEP) and a Collaborative Research and Development Agreement (CRADA) with the US Pharmacopeia (USP). 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 Philadelphia 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,  public health outbreaks, and for the purpose of routine surveillance. In addition to the scientific analyses performed by PHIL, the laboratory staff also support domestic and foreign pre-approval, surveillance, and for-cause inspections.

Specialized Capabilities

The Philadelphia Laboratory also has the capability to test pressurized topical aerosols, metered-dose inhalers, and propellant-free dry-powder inhalers used to aerosolize and meter, doses of powder for inhalation. This includes breath-actuated or dose-metering nebulizer units, with inhalants formulated as suspensions or solutions of active drug in propellants and dry-powder inhalers, marketed as single or multi-dose units.  Additionally, PHIL assists in leading analytical method optimization efforts for the analysis of transdermal drug delivery systems.  The drug analysis performed in PHIL 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  instrumental capabilities to include screening for toxins and poisons and PDE 5 inhibitors using liquid chromatography/mass spectrometry (LC/MS), and screening for weight-loss drugs in dietary supplements using gas chromatography/mass spectrometry (GC/MS).