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SGS S.A.

  • 1 place des Alpes
  • P.O. Box 2152
  • 1211   Geneva 1
  • Switzerland
  • t   +41 22 739 91 11
  • f   +41 22 739 98 86
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Minimize menuMaximize menuHomeConsumer Goods & RetailMedical Device as Consumer ProductsPackage & Container TestingExtractables & Leachables Testing

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Extractables and Leachables Testing

The assessment of extractables and leachables in bio/pharmaceutical products is an important step in drug product development. Processing equipment, as well as primary and secondary container closures are potential vectors for chemical contaminants.

Monomers and polymer additives such as antioxidants, plasticisers, stabilizers, dyes, metal catalysts and other harmful chemicals may potentially migrate into the product under storage conditions. SGS provides a complete service for testing extractables in container materials and leachables in final products. These tests are conducted in cGMP compliant laboratories using technologies that detect ultra trace levels.

Extractables Testing, Leachables Testing

  • Test strategy planning and data evaluation based on the available information
  • Development of a tailored study design for extractables and leachables
  • Extractables profiling (inorganic and organic extractables)
  • Sequential extractions and alternative extraction techniques for isolating extractables in container materials
  • Characterization of extractables by chromatographic and spectroscopic investigations
  • Determination of the Analytical Estimation Threshold (AET)
  • Calculation of the qualification threshold based on Safety Concern Threshold (SCT)
  • Method development and validation of potential leachables in pharmaceutical products
  • Performing of leachables studies on pharmaceutical products reporting and evaluation of results within the current guidelines

Extractables and Leachables Testing and Assessment Technologies

  • HPLC-MS/MS, HPLC Q-Tof, HPLC-UV, DAD
  • HS-GC, HS-GC-MS
  • GC (FID, ECD, FID-NP), GC-MS
  • GC-TEA (nitrosamines)
  • ICP-OES, ICP-MS, AAS, IR
  • FTIR
  • TGA, DCS
  • X-ray fluorescence analysis
  • Accelerated Solvent Extraction (ASE)
  • Soxhlet

Contact SGS today to learn how we can help with your extractables and leachables testing.

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Extractables & LeachablesWebinarExtractables and LeachablesWhen designing extractables and leachables studies, to help maintain product safety, quality, and efficacy, the studies should include evaluating and

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Contact

SGS S.A.

  • 1 place des Alpes
  • P.O. Box 2152
  • 1211   Geneva 1
  • Switzerland
  • t   +41 22 739 91 11
  • f   +41 22 739 98 86
  • e   Email Us

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    Global Offshore Wind - Renewable UK 2012
    On June 13-14, 2012, SGS will be attending the 11th RenewableUK Global Offshore Wind 2012 Conference and Exhibition in London, UK. At stand 545, SGS’s team of experts will demonstrate a wide portfolio of renewable energy services for the entire project life cycle including, but not limited to, commissioning, in-service and end of warranty inspections, quality, health, safety and environmental (QHSE) management, risk management, non-destructive testing (NDT) as well as wind turbine blade testing.

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    SGS Webinar – New EU Toy Directive: Are You Up-To-Date?
    The objective of this 1-hour complimentary webinar is to give you an overview of the major changes of the new EU Toy Directive 2009/48/EC. We will provide a step-by-step implementation program to help you ensure compliance with all the new requirements.
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