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

Extractables Leachables studies

Extractables and Leachables testing is 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 perform Elemental impurities analysis.

Extractables Leachables studies Equipment & Techniques

E/L studies are performed 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

Pharmaceutical Packaging testing

  • 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

European Pharmacopeia - Materials Testing

  • 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

Testing is conducted according to method described in current edition of Ph.Eur. Monographs:

  • (3.1.3) Polyolefins
  • (3.1.4) Polyethylene without additives for containers for parenteral preparations and for ophthalmic preparation
  • (3.1.5) Polyethylene with Additives for Containers for Parenteral Preparations and for Ophthalmic Preparations
  • (3.1.6) Polypropylene for Containers and Closures for Parenteral Preparations and Ophthalmic Preparations
  • (3.1.15) Polyethylene Terephthalate for Containers for Preparations not for Parenteral Use
  • (3.2.2) Plastic containers and closures for pharmaceutical use

Plastic containers and closures for pharmaceutical use are made of materials in which may be included certain additives; these materials do not include in their composition any substance that can be extracted by the contents in such quantities as to alter the efficacy or the stability of the product or to present a risk of toxicity.

For selection of a suitable plastic container, it is necessary to know the full manufacturing formula of the plastic, including all materials added during formation of the container so that the potential hazards can be assessed.

For Leachables & Extractables studies or Packaging Migration studies contact us –  [email protected] – +30 210 29 34745