Extractables and leachables

Extractables and Leachables Testing in the Pharmaceutical Industry

Requirements from regulatory agencies have become increasingly rigorous, with regards to the detection, identification and quantification of extractable and leachable compounds in pharmaceuticals, drug delivery systems and biomedical devices. This increased scrutiny is the result of several well-documented incidents of contaminants leaching from containers and packaging, resulting in a potential or real risk to humans.  As a result, regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA), have increased regulations on potential extractables and leachables in drug product container and closure systems. 

This paper will:

  • Define extractables and leachables
  • Explain the regulatory requirements
  • Highlight the multiple methods and state-of-the-art technology required to obtain accurate and reliable results

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