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.

• Laboratory Services by SGS

  A comprehensive look at SGS’s global lab services (PDF 1,4MB)
  Lab Services (1498 KB)
• Complete Global Solutions for Electro-Medical Devices

  Get your product to market faster. We know the way.
  Electro-Medical Devices (862 KB)

• Drug Container Closure Testing

  Extraction method impact on heavy metal detection (PDF 199KB)
  Drug Container Closure Tests (199 KB)
• Drug Container Closure Testing Poster

  Poster presented at 2010 AAPS Annual Meeting (PDF 160KB)
  Drug Container Closure Tests (160 KB)
• Extractables & Leachables:

  A video introduction to the investigation of extractables in container / closure systems and for the investigation of leachables in final product formulations.
  E and L Testing (14722 KB)

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  Lab Services

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  Electro-Medical Devices

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  Drug Container Closure Tests

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  Drug Container Closure Tests

  published 02/29/12

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  E and L Testing

  published 02/07/13

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  Interactive Pocket Map

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  Extractables & Leachables

  published 02/28/12

  Video