Extractables and leachables testing

Extractables and leachables studies are essential in providing the necessary analytical data for regulatory submission.

With an array of modern technologies, knowledge of regulatory issues and complimentary CMC analytical capabilities, this makes us your ideal partner for extractables and leachables studies. We have a wealth of experience in assessing extractables and leachables for a wide range of products, including:

  • Pharmaceuticals
    • Container closure systems (plastic/glass bottles, stoppers, blow seal vials, labels etc.)
    • Pre-filled syringes
    • Transfer systems (tubing, iv bags, connectors etc.)
    • Parenteral, ophthalmic, dermal, topical, orally inhaled and nasal drug products, metered dose inhalers
  • Biopharmaceuticals
    • Container closure systems (plastic/glass bottles, stoppers, blow seal vials, labels etc.)
    • Pre-filled syringes
    • Transfer systems (tubing, iv bags, connectors etc.)
    • Single use systems / process contact materials (tubing, gaskets, filters, bags, o-rings etc.)
    • Parenteral, ophthalmic, dermal, topical, orally inhaled and nasal drug products, metered dose inhalers
  • Consumer Healthcare
    • Container closure systems (plastic/glass bottles, stoppers, laminated tubing, labels etc.)
    • Creams, ointments, toothpaste, shampoo
  • Medical Devices
    • Whole or component parts according to ISO-10993 (Biological Evaluation of Medical Devices)
  • Animal Healthcare
    • Container closure systems (plastic/glass bottles, stoppers, blow seal vials, labels etc.)
    • Tags, implants

 

Techniques

  • Solvent extraction including ultrasonication, reflux and microwave
  • Headspace GC-MS (Volatile Organic Compounds)
  • GC-MS and GC-FID (Semi-Volatile Organic Compounds)
  • HPLCDAD- MS/MS (Non-Volatile Organic Compounds)
  • ICP-MS (Inorganic Compounds)
  • FT-IR, HRAM-MS and NMR (structural elucidation and unknown ID)

 

Applications

  • Screening studies to aid single use manufacturing component, container closure system component, transfer system component or medical device component selection
  • E&L studies for regulatory submission
  • Managing forced or elective changes in single use manufacturing components, container closure system components, transfer system components or medical device components
  • Method development, validation and technology transfer of analytical methods for product testing and quality control

 

Toxicological Risk Assessment

The data generated by LGC’s E&L studies can be used for toxicological assessment of any specific compounds as part of a human health risk assessment package.  We partner with one of Europe’s leading chemical hazard and toxicology risk consultants to provide this service to our customers.