Leachables Extractables studies, Leachables Extractables testing services, Packaging compatibility studies, Packaging Testing for Pharmaceuticals

Extractables and Leachables studies are a prerequisite for FDA & EMA (European Medicines Agency) compliance. Migration studies for pharmaceutical packaging materials (extractables and leachables) are an essential process in identifying and quantifying traces deriving from pharmaceutical containers, medical device packages and equipment used in the manufacturing process. We test for organic and inorganic components, Volatile, Nonvolatile residues and Elemental impurities.

E/L studies Equipment & Techniques

E/L studies are perfomed with

  • High-performance liquid chromatography (HPLC)
  • Gas chromatography mass spectrometry (GC-MS)
  • Liquid chromatography mass spectrometry (LC-MS)
  • Inductively coupled plasma mass spectrometry (ICP-MS)
  • Ultraviolet-visible spectroscopy (UV-VIS)

Packaging Migration/Compatibility studies

Packaging testing for pharma

  • Appearance of solution
  • Absorbance Acidity / alkalinity
  • Reducing Substances
  • Extractable Al, Ti, Zn
  • Extractable heavy metals
  • Sulfated ash
  • Plastic additives
  • Phenolic and non-phenolic antioxidants
  • Amides and stearates

For Leachables & Extractables studies or Packaging Migration studies contact us –  info@qacs.gr – 30 210 29 34745