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Extractables and Leachables (E&L) study design

here is a practical framework used for pharmaceutical packaging, drug-delivery systems, and manufacturing components.

Define the objective

  • Identify potential compounds that can migrate from a packaging/component into the drug product.

  • Assess patient safety and product quality.

  • Establish whether detected leachables are within acceptable limits.

extractable-leachable-diagram-800x600.png

Leachables study

Extractables study

  • Solvents: water, aqueous/organic mixtures, alcohols, nonpolar solvents as appropriate

  • Temperature: e.g., room temperature, 40–50°C, or higher depending on material

  • Time: hours to weeks depending on the study objective

  • Surface-area-to-volume ratio: representative or exaggerated

  • Multiple extraction conditions may be needed to cover polar, semi-polar, and nonpolar compounds.

Leachables study
Use the actual drug product or a justified surrogate under realistic storage conditions.

Example sampling plan:

  • Initial

  • 1 month

  • 3 months

  • 6 months

  • 12 months

  • End of shelf life

The exact intervals should match the product's proposed shelf life and stability program.

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