ABSTRACT
Introduction e potential for adulteration of nished drug products by extractable and leachable compounds from the container or closure systems continues to receive greater attention and scrutiny by regulatory authorities. Consequently, numerous types of guidance including reviews have been published to assist drug manufacturers in providing adequate information regarding the identity, quantity, and control of such compounds to ensure the quality and/or safety of the drug product [1-4]. e focus of these documents is the requirement by the pharmaceutical industry to investigate both analytically and toxicologically compounds that may potentially leach from the packaging materials into the drug products [4, 5].
