The term ‘‘leachables’’ refers to impurities in pharmaceutical products with an origin of the pharmaceutical container closure system in either direct or indirect contact with the formulation. Pharmaceutical regulatory authorities, such as European Medicinal Agency (EMA) and Food and Drug Administration (FDA), periodically issue guidelines on leachables quantitation in pharmaceutical manufacturing and finished drug product. These guidelines make it critical to be able to develop an accurate and generalized method at ultra-low levels for the leachable impurities. Read more >