Extractables & Leachables studies, E&L Testing, Elemental impurities analysis, Pharmaceutical packaging testing, Extractables Leachables testing servicesanalysis, Leachables Extractables

Extractables Leachables studies

At QACS Lab, we specialize in conducting comprehensive Extractables and Leachables studies for pharmaceuticals. Containers and closures utilized in pharmaceutical packaging may contain various additives, but it’s crucial to ensure that these materials do not release substances that could compromise the efficacy, stability, or safety of the product. To select the most suitable container, a thorough understanding of the complete manufacturing formula, including all materials used in its formation, is essential for assessing potential hazards.

Our Extractables and Leachables testing services are vital for achieving compliance with regulatory bodies such as the FDA and EMA (European Medicines Agency). These studies involve meticulous analysis to identify and quantify any traces originating from pharmaceutical containers, medical device packages, and manufacturing equipment. Our testing procedures cover a wide range of organic and inorganic components, including volatile and nonvolatile residues, alongside Elemental Impurities analysis. Extractables and leachables studies could be performed in final container closure systems (CCS), process equipment (single use systems, SUS) or medical device packaging.

Available Testing

At QACS Lab we perform E&L studies using:

  • 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)
  • Liquid Chromatography–high-resolution mass spectrometry (LC–HR–MS )

Packaging Testing for Pharmaceuticals is conducted according to methods described in the current editions of Ph.Eur. Monographs (3.1.3), (3.1.4), (3.1.5), (3.1.6), (3.1.15), (3.2.2). At QACS Lab we test for:

  • 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
  • Real Time, Accelerated (ASTM F1980)
  • ICH Storage stability services