Extractables & Leachables

Eos Scientific provides a full analytical services for extractables and leachables testing.

In industry leachables and extractables studies are now increasingly important. Regulatory pressure has increased the manufacturing industries to show that no toxic or harmful substances from packaging materials migrate into a product during its shelf life.  And chemical contamination can also occur from processing equipment or container enclosures.

Eos Scientific assesses extractables and leachables in a wide range of products and we provide a complete analysis service to detect extractables in container materials and leachables in final products.

If you require analysis for extraction and characterisation of polymeric materials and additives including specific targets such as PAHs and nitrosamines, we can also identify and quantify these compounds present and assess the chances of exposure.

We provide

  • Extractable/Leachable evaluations
  • Extractable Screening (Intelligent Planning for Materials Selection)
  • Ensure Compatibility of Product & Packaging
  • Method Development & Validation for Leachables Study
  • Develop Routine Extractable Control Methods
  • Label Migration Studies
  • Packaging Safety & Toxicity Analysis
  • Controlled Extraction Studies for Raw Material Control
  • Food Contact Notification & Migration Studies
  • Ensure safety relative to packaging adulterants that might enter the supply chain
  • Supporting of risk analysis procedures
  • Development of a tailored study design for extractables and leachables or chemical characterisation
  • Extractables profiling (inorganic and organic extractables)
  • Sequential extractions and alternative extraction techniques for isolating extractables in materials made from polymers, metals and ceramics
  • Characterisation of extractables by chromatographic and spectroscopic investigations
  • Identification of a material and the identification and quantitation of the chemicals present in materials by chemical characterisation
  • Identification and evaluation of the physico-chemical, mechanical, morphological and topographical properties of materials
  • Chemical and structural changes on materials after stressing by temperature or irradiation
  • Determination of the Analytical Evaluation Threshold (AET)
  • Calculation of the AET based on Safety Concern Threshold (SCT) or Threshold of Toxicological Concern (TTC) and ICH M7 guideline
  • Toxicological assessments and method development and validation of potential leachables in pharmaceutical products and from medical devices
  • Extractables and leachables testing and assessment technologiesMaterial and process qualification and validation for in-process manufacturing from an extractables/leachables perspective
  • Controlled extraction studies with LC-MS, GC-MS direct injection and GC-MS headspace injection sample analyses with data interpretation and toxicity assessment services
  • Leachables method development and validation studies
  • Material qualification for polynuclear aromatic hydrocarbons (PAH), N- nitrosamines and other toxicologically concerned compounds
  • Leachables monitoring for stability studies and routine extractables testing
  • Reference standards for many extractable compounds commonly formed during the manufacturing process of the container/closure systems or their resins, including some that are not commercially available
  • Devise strategies for testing polymeric materials
  • Extractables screening, leachables monitoring
  • Method development, validation and technology transfer of analytical methods for product testing and quality control

Techniques

  • Solvent extraction including ultrasonication, microwave, ASE (Automated Solvent Extraction), Soxhlet and Soxtect
  • Gas Chromatography (GC) coupled to Mass Spectrometry (MS) or flame ionisation (FID) detectors, also available with headspace injection
  • High performance liquid chromatography coupled to diode array UV detector and tandem mass spectrometry (HPLC_DAD- MS/MS)
  • Inorganic analysis with Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
  • UPLC and HPLC-MS/MS
  • Semi-preparative fraction collection by HPLC
  • Accurate mass assignments by mass spectrometry
  • Peak purity
  • GC (FID), GC-MS
  • LC-MS-MS (nitrosamines)
  • HPLC-MS/MS (ESI) perfluorinated acids (PFCA)
  • ICP-OES, ICP-MS
  • Accelerated Solvent Extraction (ASE)
  • Soxhlet and reflux extraction
  • Static or dynamic liquid extraction by pumping through; simulated use and migration studies

Note: This is a non-exhaustive list of techniques we propose. All techniques should be tailored to each specific product

Please contact us for detailed information that will be suitable for your product.