Extractables and Leachable Studies

We Perform Extractable And Leachable Testing On:

  • Containers (HDPE, LDPE, PP), Plastic bags, Rubber stoppers, Gaskets & O-rings, Prefilled syringes, Implants, Glass vials, Syringes, Resins, Injectable bags / vials, Films, Blister packs, Laminated tubes, Tubing & filters and etc.,
  • Primary Containers, Auxiliary Articles and Manufacturing Aids used for various drug products such as Solids, Parentals, Injectables, Ointments, Lotions, Syrups, Suspensions, Gels, Inhalations, Creams & Emulsion, Transdermal Patches etc.,

Our Extractable And Leachable Services Include:

  • Design, develop and execute the E&L study for pharmaceutical industry according to the various regulatory guidelines and recommendations such as USFDA (USP <1663> and <1664> General Chapters), EMA, PQRI, ICH and/or customer requirements.
  • Extractable Profiling
  • Simulation Study
  • Leachables Screening
  • Elemental Impurities
  • Elemental Analysis for Glass delamination studies
  • Techniques used are GC-MS/MS, HS-GC-MS, LCMS, and ICPMS; soxhlet extraction apparatus and others for samples processing.