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Extractables / Leachables

Our Deliverables

  • Custom Extractables and Leachables studies for all types of container closure systems and primary packaging materials including labels, printings and adhesives.
  • Consultancy for Extractables and Leachables studies in all phases of development of a container closure system.
  • Chemical Characterization of Medical Devices as per ISO 10993.
  • Toxicological assessment of extractables.
  • USP/EP Chapter characterization studies of materials.
  • Glass Delamination Studies.
  • Material selection for devices/packaging and vendor qualification. Seminars and trainings on Extractables and Leachables.

Our Instrumentation

  • TDS - GC/MS
  • HPLC
  • LC/MS/MS
  • DSC
  • FTIR

Our Proven EL Strategy

  • Critical Assessment
  • Extractable Study
  • Leachable Check
  • Evaluation of Results
  • Tox Assessment
  • Leachable Study

Our Quality

  • USFDA registered facility.

  • E/L Studies based on PQRI & USP Guidelines.

  • Lab adopts ISO 17025 & GLP principles.

  • Risk Based approach to E/L.

  • Overall team experience on E/L more than 20 years.

  • Team experience of more than 100 studies in various dosage forms – Injectable, LVP, Ophthalmic, Labels, Transdermal patches, Creams, Liquid Orals, MDIs etc