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Extractables and Leachables Service by LGC

Manufacturer LGC  |  Available Worldwide
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As regulatory pressure increases on pharmaceutical companies to investigate the potential interaction between a dosage form and the components of the primary closure and transfer system employed, leachables and extractables studies are becoming essential. 


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Extractables and Leachables Service
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LGC has 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 (biocompatibility)
  • Animal Healthcare
    • Container closure systems (plastic/glass bottles, stoppers, blow seal vials, labels etc.)
    • Tags, implants

 
Techniques

  • Solvent extraction including ultrasonication, microwave, ASE (Automated Solvent Extraction), Soxhlet and Soxtect
  • 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)
  • Gel Permeation Chromatography (GPC)
  • FT-IR,  GC-ToF-MS, 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.