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U.S. Department of Health and Human Services

Science & Research

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Philadelphia District Laboratory (PHI)

 

PHILADELPHIA DISTRICT LAB
 
FY 10 Analysts On Board: 18
 
FY 10 Samples Analyzed: 984
 
 
Program Capabilities
 
PHI-DO Pharmaceutical Laboratory specializes in the analyses of all forms and types of drug products. Its work involves nearly all phases of drug analysis and review, including the following programs: 
  • New Drug Applications 
  • Abbreviated New Drug Applications 
  • Drug compliance and complaint samples
  • Department of Defense Shelf-Life Extension Program samples
  • Drug surveillance programs
  • Over-the-Counter and fraudulent drug samples
  • Method assessment of compendial drugs
  • Drug Quality Reporting System samples
  • Domestic inspections of pharmaceutical and veterinary drug firms
  • International inspections of pharmaceutical and veterinary drug firms
  • Inspections of contract testing laboratories
  • In-vitro biopharmaceutical research samples
 
Specialized Capabilities
 
PHI-DO 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) formulated as suspensions or solutions of active drug in propellants and dry powder inhalers marketed as single- or multi-dose units.
 
High Throughput for Drug Analysis
PHI-DO Laboratory has recently increased its mass spectroscopy capabilities to allow for the inclusion of screening for Toxins and Poisons, and PDE 5 Inhibitors using the LCMS and screening for weight loss drugs in dietary supplements using GCMS.