• Extractables and Leachable Test


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.

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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

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