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  • Home
  • About
    • Overview
    • Core Values
    • Facilities
    • Instrumentation
    • Quality Systems
    • Leadership
      • Allen Kesselring, Ph.D.
      • Jennifer Eagan
      • Katie Grayson
  • Extractables & Leachables
    • Overview
    • For Medical Devices
      • Med Device E&L
      • ISO 10993 Chemical Characterization
    • For Pharmaceuticals
      • Pharmaceutical E&L
      • USP 661, 661.1, 661.2, and 665
    • BPOG Extractables and Leachables
  • Other Expertise
    • Impurity Identification
    • Elemental Impurities
    • Material Characterization
      • Material Compatibility
      • Device Materials
        • Bioabsorbable Polymers
    • Method Development
    • Method Validation
  • Industries Served
    • Pharmaceuticals
    • Medical Devices
      • 510(k) Testing
      • PMA Testing
    • Combination Products
      • Drug-Delivery Pump Analytical Services
      • Drug-Eluting Stents
      • Intraocular Lens
      • Specialty Devices
    • Cannabis Testing
      • MoCann Testing
  • Regulatory Support
    • Overview
    • Auditing Services
    • FDA Remediation Services
  • Case Studies
    • Case Studies
    • Industry Updates
    • Lab News
  • Contact Us
    • TALK WITH AN EXPERT
    • Contact Us
    • Request a Quote
    • Schedule an Audit
    • Career Opportunities
  • Sample Submission

Case Studies

EKG Labs Team June 5, 2017

  • October 12, 2022: Pharmaceutical Leachables Part 2: USP <1664> Case Studies
  • July 19, 2022: Biopharmaceutical Impurity Investigation
  • February 7, 2022: ISO 10993 Chemical Characterization: Nasal Cannula Case Study
  • November 19, 2021: Biodegradable Polymers: Two EKG Labs Case Studies
  • August 13, 2021: Drug-Delivery Pumps: An EKG Labs Case Study
  • March 17, 2021: Hydrocortisone Impurity Investigation
  • November 22, 2020: Overcoming Elemental Impurity Challenges in IV Products
  • July 30, 2020: EKG Partners with FHI for Publication
  • June 22, 2020: Extraction Efficiency
  • October 11, 2019: Elemental Impurities in Cell Culture Media: A Case Study
  • June 28, 2019: Additive Stability Analysis
  • May 31, 2019: Transferring Methods for Pharmaceutical Analysis
  • April 26, 2019: HPLC Detection of PAHs in Challenging Pharmaceutical Matrices
  • March 1, 2019: An Updated Method for Analyzing Deuterium Content in Pharmaceuticals
  • July 31, 2018: Syringe Discoloration, Heavy Metals, and ICP-MS: A Case Study
  • May 31, 2018: Inhalation Device Extractables : A Case Study
  • February 27, 2018: Adhesive Impurities in Medical Devices
  • November 29, 2017: Extractables Study on Microneedle Patches
  • August 28, 2017: Extractables and Leachables Study on Packaging for a Liquid and Gel Drug Product
  • June 27, 2017: Leachable Determination in a Medical Device
  • June 5, 2017: Separation of Co-eluting Impurities

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Location & Contact

EKG Life Science Solutions
2250 Welsch Industrial Court
Saint Louis, MO 63146

Tel: 810-354-5229
Contact Us

Upcoming Events

MD&M West
Booth 2564
Anaheim, CA
February 7-9, 2023

Extractables & Leachables Summit 2023
Philadelphia, PA
April 17-18, 2023

Combination Products Summit 2023
Philadelphia, PA
May 16-17, 2023

Extractables & Leachables USA 2023
Arlington, VA
May 17-18, 2023

EKG Labs Updates

  • EKG Labs Looks Forward to 2023

    EKG Labs Looks Forward to 2023

    January 31, 2023
    2023 is kicking off in high gear at EKG Labs.  Some of our plans for the year include: We are …
  • EKG Labs Acquires New Instrumentation for E&L Studies

    EKG Labs Acquires New Instrumentation for E&L Studies

    November 16, 2022
    EKG Labs is now the proud owner of an Agilent Ultra High Performance Liquid Chromatograph (UHPLC) with Quadrupole Time of …
  • Pharmaceutical Leachables Part 2: USP <1664> Case Studies

    Pharmaceutical Leachables Part 2: USP <1664> Case Studies

    October 12, 2022
    A Refresher on USP <1664> Pharmaceutical leachables are chemical entities from packaging or delivery systems which migrate into a drug product …
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2250 Welsch Industrial Court
Saint Louis, MO 63146

Tel: 810-354-5229
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