Extractables: Chemical compounds that migrate from any product-contact material when exposed to an appropriate solvent under exaggerated conditions of time and temperature.

Leachable: Chemical compounds, typically a sub-set of extractables, which migrate into drug formulation from direct product contact under normal process conditions or accelerated storage conditions.

Leachable Evaluation Procedures

Leachable Analysis Methods

Example Case
Filter extractable and leachable when impurities detected in the drug
Solvent: 95% Alcohol, 5% polystyrene
Process Conditions: 50℃, 60 hours vibrating