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EXTRACTABLE AND LEACHABLE IMPURITIES

Prevent health risks due to toxicological properties.


 
Materials used in pharmaceutical packaging systems, can migrate to the pharmaceutical product and may cause a change in its composition and a serious health risk due to their toxicological properties.

Extractables are those compounds that can be extracted from plastic components, elastomers or coatings of the packaging system under forced laboratory conditions. Leachables are the sub-fraction of extractables that mitigate into the product over its shelf-life under normal ICH storage conditions.

It is a regulatory requirement that toxic substances in packaging materials do not migrate to the pharmaceuticals during their shelf life to avoid changes in the therapeutic action, organoleptic properties or stability.

We offer an integrated toxicological analysis and evaluation service, totally customized to the needs of our clients.
We conduct complete studies of extractables substances and develop methods to monitor the presence of leachables products in the final product with highest standards:

  • The studies are conducted in specialized GMP and FDA certified analytical laboratories, that have the technology to detect ultra-trace levels.
  • Toxicological Assessments are preformed by our experts in toxicology, a multi-disciplinary team with ERT toxicologist and members accredited by AETOX & EUROTOX
 

Extraction studies and qualitative and quantitative analysis:

  • Evaluation of the available information on packaging materials, production procedures and equipment, and final products.
  • Development of analytical methods.
  • Characterization of packaging materials, including evaluation of their physical-chemical, mechanical, morphological and topographical properties.
  • Extraction studies, analysis and characterization of extractables and leachables substances (volatile and semi-volatile).
  • Toxicological evaluation of the detected impurities. Definition of safety limits. Risk analysis based on exposure levels to the extractable and/or leachable substance in the final product.

Toxicological evaluation and risk analysis :

  • Toxicological evaluation of the impurities detected via: literature reviews, data migration via read-across, in silico toxicology endpoint prediction methods, etc.
  • Definition of safety limits and their adjustment depending on the medication administration route.
  • Risk analysis based on exposure levels to the extractable and/or leachable substances in the finished product, considering their toxicological limits.
  • Presentation of findings and production of reports in accordance with the current legislation (FDA, EMA, PQRI, PDA).
 

For more Information

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