Douglas Labs

TRUST. IN NUTRITIONAL HEALTH.

DOUGLAS LABORATORIES' UNSURPASSED QUALITY

At Douglas Laboratories®, there is no greater mission than assuring that each and every supplement produced is of the highest quality.

When you see the Douglas Laboratories “Emblem of Quality,” DL Emblem of Qualitybe assured that only the finest raw materials are being used and that all manufacturing is performed under the strictest of guidelines.

Because these products are developed specifically for exclusive distribution by healthcare professionals, our emblem has become a recognized symbol of quality that patients around the world have come to rely upon and trust.


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NEW IN-HOUSE LABORATORIES ENSURE OVERALL PRODUCT QUALITY

Our NEW and much expanded (3,000 sqft.) in-house laboratories, under the supervision of our staff Ph.D.s, constantly monitor quality. From receipt of raw materials in our facility through testing dosage potency and tablet/capsule disintegration, our in-house labs ensure product quality and consistency.

  • In house ISO-17025 accredited laboratories have the ability to test for:

Microbiological contamination including:

-Total aerobic plate count
-Yeast
-Mold
-E. coli
-Pseudomonas
-Salmonella
-Staphylococcus
-Aflatoxins

    Also including: Identity, Purity, Quality, Strength and Composition

    -Bacterial Enumeration
    -Disintegration
    -Dissolution
    -Hardness
    -Friability
    -Gluten
    -Peroxide Value 

    • Fourier Transform Near Infrared Spectroscopy (FT-NIR)
    • High Performance Liquid Chromatography (HPLC)
    • Ultra Performance Liquid Chromatography (UPLC)
    • Gas Chromatography (can measure organic volatile impurities)
    • Gas Chromatography with Mass Spectroscopy (can measure pesticide residues)
    • ICP-OES and ICP-MS (can measure minerals and heavy metal impurities, respectively)


    CERTIFICATIONS:

    Our world-class manufacturing facilities comply with federal and other worldwide regulatory bodies.

    • FDA
    • Health Canada
    • NSF-GMP registered Manufacturing Facility
    • ISO-9001 Certification
    • ISO-17025 Accreditation of our onsite analytical laboratories
    • Strict vendor qualification program

    Chemical Analysis Laboratories
    Ensuring potency of formula components using:

    HPLC High Performance Liquid Chromatography is a form of column chromatography used frequently in biochemistry and analytical chemistry to separate, identify, and quantify compounds. HPLC is used to test vitamins.

    UPLC Ultra Performance Liquid Chromatography systems take advantage of technical pace in particle chemistry performance, systems optimization, detector design and data processing. This new category of analytical separation science retains the practicality and principals of HPLC while increasing the overall interrelated attributes of speed, sensitivity and resolution. UPLC is used to test vitamins and herbs.

      ICP-OES and ICP-MS are used for bulk elemental chemical analysis of just about any material or substance (water, biological materials, inorganic materials of all sorts, environmental samples, geological samples, etc.). Most of the periodic table (with the exceptions of H, O, N, F, CI) can be measured using ICP-OES and ICP-MS. ICP-MS can be used to test for heavy metal impurities (arsenic, cadmium, lead and mercury). In many cases ICP-MS is able to detect elements down to the parts per billion or parts per trillion level.

      GC-MS Gas Chromatography with mass spectrometry is a method that combines the features of gas-liquid chromatography and mass spectrometry to identify different substances within a test sample. The GC-MS has been widely heralded as a “gold standard” for forensic substance identification because it is used to perform a specific test. A specific test positively identifies the actual presence of a particular substance in a given sample. GC-MS can be used to test for pesticide impurities.

      GC-FID A flame ionization detector is a type of gas detector used in gas chromatography. The detection of organic compounds is most effectively done with flame ionization. Biochemical compounds such as proteins, nucleotides, and nutraceuticals can be studied with flame ionization. With headspace sampling, GC-FID is used to test for volatile impurities, OVIs.

      FT-NIR Infrared spectroscopy is the subject of spectroscopy that deals with the infrared region of the electromagnetic spectrum. As with all spectroscopic techniques, it can be used to identify compounds or investigate sample composition. Fourier transform spectroscopy is a measurement technique whereby spectra are collected based on measurements of the coherence of a radiative source, using time-domain or space-domain measurements of the electromagnetic radiation or other type of radiation. This instrument is used for raw material ID testing.

      GF/AA Atomic Absorption Graphite Furnace Spectrometer. The sensitivity of GFAA enables performances of elemental analysis that are virtually impossible using other analytical techniques. These are used to determine ppm and sub ppm levels of residuals in metals. This method is particularly pertinent in material analysis for the detection of trace metals.

      • Physical Analysis Laboratory

      Ensuring dosage weight variation, hardness, disintegration, and overall consistency and appearance.

      • Microbiology Laboratory

      Testing all raw materials and products for yeast, mold, and bacterial purity in accordance with USP/AOAC, when applicable.

      • Formulating/New Product Development

      Dr. Andrew Halpner, Vice President of Product Development and Technical Services, received his Ph.D. in Nutrition from the Friedman School of Nutrition Science and Policy at Tufts University. His extensive research and interests focus around antioxidant nutrients, including their interactions and abilities to prevent and treat age-related degenerative illnesses. Dr. Halpner has lectured nationally and internationally on various topics pertaining to nutrition and has authored numerous articles. In addition, Dr. Halpner also serves as the Chief Editor for NutriNews, our nutrition publication.

      • Manufacturing Quality

      Dr. Naeem Shaikh, Vice President of Research and Development, has been with Douglas Laboratories® for over two decades and leads the Manufacturing and Quality Departments. Dr. Shaikh earned his Ph.D. in Pharmaceutics from Duquesne University and additional degrees in Pharmacy from Duquesne and the University of Karachi in Pakistan. As the author of ten published papers covering topics from dietary supplements to controlled-release drug delivery systems, Dr. Shaikh has expertise in all facets of manufacturing and quality control and assurance at Douglas Laboratories®.

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      Your patients trust you.
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      1-800-245-4440

       

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