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Extractables and leachables

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.

LGC helps clients to identify and quantify the nature of the compounds present in contacting components and the likelihood of clinical exposure to these.

Applications

  • Devise strategies for testing polymeric materials
  • Full analysis of leachables and extractables on various delivery systems, including inhalers, injectables, catheters and blister packs
  • 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
  • Two dimensional GC Time-of-Flight MS
  • High performance liquid chromatography coupled to diode array UV detector and tandem mass spectrometry (HPLCDAD- MS/MS)
  • Gel Permeation Chromatography (GPC)
  • Spectroscopy with Fourier Transform Infra Red (FT-IR) and Nuclear Magnetic Resonance (NMR)
  • Inorganic analysis with Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and Atomic Absorption (AA)


Our expertise

LGC has considerable experience in the extraction, deformulation and characterisation of polymeric materials and additives including specific targets such as PAHs and nitrosamines. Our expertise in this area, combined with an array of modern technologies and knowledge of regulatory issues, makes us your ideal partner to carry out leachables and extractables studies.