Extractables and Leachables

During the production phase of a drug or during the storage phase, numerous contaminants may be released from the materials through direct or indirect contact between the packaging material and the active substance or formulated product. 

These molecules are called Extractables or Leachables and their determination is one of the regulatory requirements for patient safety

Extractables are all compounds that can be extracted from materials when brought into contact with solvents/simulants under controlled time and temperature conditions, which are worse conditions than those of normal use. Extractables can potentially migrate into the drug.  

Leachables are all compounds that migrate into the drug product from any material as a result of contact, direct or indirect, between the material and the product itself during the production phase or during storage of the drug product.  

LabAnalysis has consolidated experience from performing hundreds of Extractables and Leachables studies on a very wide range of materials (primary and secondary packaging, dispensing and dosing systems, industrial components, filtration systems, etc) and pharmaceutical products (active pharmaceutical ingredients and formulated products).

LabAnalysis also has state-of-the-art chromatographic and structural characterisation technologies

  • HPLC-MS positive and negative HPLC-MS for non-volatile compound
  • CS-MS for semi-volatile compounds 
  • ICP-MS for elemental impurities (metals) 
  • GC-MS or HPLC-MS for nitrosamines 
  • HS-GC / MS to highlight volatile compounds (test performed directly on packaging) 
  • IC to highlight ionic compounds 

LabAnalysis guarantees the sharing of the technical approach of Extractables and Leachables studies with the Customer by drafting a Study Protocol containing information regarding the purpose of the activity, analytical methods, sample extraction and processing conditions, processing and presentation of results, regulatory references. At the end of the experimental activity LabAnalysis guarantees the drafting of the relevant Study Report containing all the experimental information, numerical data obtained, structural characterisations, chromatographic plots and discussion of the results.

For further information on Extractables and Leachables

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