ANTONIO CONTO
Chemsafe, Colleretto Giacosa (TO), Italy

DEFINITIONS
Extractables are chemical substances that can be extracted from the product using aggressive solvent conditions including acidic, basic, organic and aqueous solvent and sohxlet or accelerated solvent extraction. Extractable studies are typically carried out to create a worst-case scenario and support the substances selection and early risk assessment.

Leachables are chemical substances that can be migrate into the normal pharmaceutical product during the storage conditions during product lifetime. It’s useful to carry out forced or accelerated leachable studies to assess leachables that migrate under simulated environmental conditions by analyzing the drug formulation after exposure to elevated temperatures. However, if the leachable interacts with the drug product or packaging material, new components can be present. These chemicals are called secondary leachables. Drug formulation often contains buffers, surfactants, fillers and other excipients; it results that secondary leachables can only be quantified after long stability studies over the typical drug shelf life.

Extractables and leachables ...