Extractables & Leachables

White Paper: Extractables & Leachables

Published January 2021


Extractables are chemicals that, under forced conditions, extract from components of a manufacturing or packaging system into a solvent. Compounds that can migrate into the drug product because of contact with manufacturing systems, container closure systems, and drug delivery device components are known as leachables. The assessment of any detected extractables and leachables that are above the analytical evaluation threshold is critical to determining the overall product safety.

This white paper covers:

  1. Impurity classification and sources
  2. Extractables & Leachables Study Design
  3. Extractables & Leachables Control
  4. E&L Studies and Testing
  5. E&L Global Regulations
  6. Impurity Reporting
  7. E&L Assessment Process

Keywords: impurity, extractables, leachables, API, API manufacturing, ICH, critical material atribute, FDA, EMA, Health Canada, pharmacopeia, ISO, packaging

Click here to view White paper: Extractables & Leachables