Extractables and Leachables Studies

Energon Labs is a one Stop solution for testing Extractables in Container closure systems, Single-use manufacturing components, Ink migration, Glass delamination, Chemical characterization of Medical devices and Leachable studies in all dosage forms. We provide assessment of extractable and leachable in bio/pharmaceutical products as an important step in drug product development and material qualification procedures. Our team has relevant expertise to deliver extractable studies for wide range of articles including:

  • Vials, Stoppers 
  • SS / alloy components
  • Gaskets 
  • Pre-filled syringes 
  • COC, COP Containers 
  • O-Rings 
  • Polymer tubing 
  • LDPE / HDPE bags 
  • Ophthalmic CCS
  • Medical devices 
  • Filters
  • Plungers etc. 

Our Approach

Integrated Solutions for E&L Challenges:

  • Regulatory agencies require extractables and leachables (E&L) testing for medical devices, manufacturing components, container closure systems and pharmaceutical drug products:
      • To identify the safety risk posed to the patients from exposure to the leachables
      • To identify any risk of product adulteration
      • To identify toxic or harmful materials in the medical devices

      We provide the assessment of extractables and leachables in bio/pharmaceutical products as an important step in drug product development and materials qualification procedures.
  • Testing and Assessment Techniques at ENergon Labs

    • Our extractable and leachable studies can be designed per guidance’s such as USP , , , , & as well as ISO 10993, PQRI, BPSA and BPOG documents. We design studies to meet the expectations of FDA’s CDER/ CBER/CDRH, EMEA, and other regulatory bodies.

      We have established the semi-quantitative screening methodology to analyse extraction solutions by LC/Q-TOF/MS, LC/MS/MS, GC/MS/MS, IC and ICP/MS. If necessitated, quantitative methods can be developed for target compounds.

      • Semi-quantitative screening for both volatile and semi-volatile organic compounds
        • Use of GC/MS instrumentation with direct injection sample introduction and electron impact ionization.
        • Use of GC/MS instrumentation with headspace sample introduction and electron impact ionization.
        • For extractables & leachables detected by GC/MS analysis, we utilize up-to-date NIST database to assist in identification.
      • Semi-quantitative screening for non-volatile organic compounds
        • Analysis using LC/MS/MS (in positive and negative mode using electrospray and atmospheric pressure chemical ionization), and LC/UV.
        • Analysis using HRMS - UHPLC QTOF/MS with Agilent library of 4000+ compounds.
      • Semi-quantitative analysis for metals
        • Evaluation of samples for elemental extractables, including all those listed in USP and ICH Q3D using ICP/MS.
      • Gravimetric determination of extractables as Non-volatile residue.
      • Ion Chromatography for Ionic extractables.
  • Instrumentation
      • LC/MS/MS - Shimadzu 8060 NX & Agilent 6470
      • LC/Q-TOF/MS - Agilent 6545 XT Advance Bio LC/Q-TOF
      • GC/MS/MS with headspace, direct injection - Agilent 7010 B & 7010 C
      • ICP/MS - Agilent 7850 & Perkin Elmer Nexion 1000
      • IC - Thermo scientific ICS 5000
      • Reflux & Soxhlation
      • Sonication & Microwave
      • Incubation in controlled temperature conditions (with agitation or recirculation if needed)
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