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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

Industry Updates

Learn about industry updates and more.

  • September 7, 2022: Pharmaceutical Leachables Part 1: Understanding USP <1664>
  • April 16, 2021: Nitrosamine Impurity Guidance
  • February 10, 2021: An Introduction to the Analytical Evaluation Threshold
  • October 16, 2020: Are your BPOG protocols up to date?
  • March 5, 2020: The Updated ISO 10993-18
  • September 11, 2019: An Overview of ISO 10993 and Biocompatibility
  • August 31, 2018: USP 1663 and 1664 – The ABCs of E&L
  • June 29, 2018: USP 476 – Expanding Regulations on Organic Impurities
  • January 31, 2018: BPOG and the USP – Mitigating Leachable Risk in Biopharmaceutical Manufacturing
  • September 28, 2017: USP 661.1, USP 661.2, and More! – Untangling the Impact of Plastics on Pharmaceuticals

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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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