Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Field Science and Laboratories

Field Science and Laboratories

                        FDA Satellite Laboratories
          Method Validation Guidelines
          Laboratory Information Bulletins
          Requesting a Laboratory Information Bulletins (LIB)


                        Private Laboratory Testing
          Field Science - Laboratory Manual Home
          Science & Research
          Field Science and Laboratories
          Detroit Medical Products Laboratory (DETLMP)Field Science and Laboratories Detroit Medical Products Laboratory (DETLMP)
  
  	
    Share
    Post
    Linkedin

    Email
    PrintPhoto banner for Detroit Laboratory

Program Capabilities

The Detroit Medical Products Laboratory (DETLMP) 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. DETLMP 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 DETLMP, the laboratory staff also support domestic and foreign pre-approval, surveillance, and for-cause inspections. In recent years, DETLMP 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

DETLMP 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.

DETLMP 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.

                                                                                  Content current as of:
      01/12/2023Field Science and Laboratories

          
                        FDA Satellite Laboratories
          Method Validation Guidelines
          Laboratory Information Bulletins
          Requesting a Laboratory Information Bulletins (LIB)


                        Private Laboratory Testing
          Field Science - Laboratory Manual
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop