The investigation of potentially toxic chemical impurities leaching from a wide variety of plastics, polymers, and packaging products destined for pharmaceutical products has received a great deal of attention and remains a challenging analysis for chemists. Often termed extract- ables and leachables (E/L) studies, their aim is to identify, quantify, and ultimately minimize any impurities that can migrate from packaging into a final product or drug. “Extractables” are those chemicals that can extract from components of a container closure system into solvents under accelerated laboratory conditions, such as elevated temperature and aggressive solvent, with the aim to extract the maximum amount without deforming or degrading the material. “Leachables” are defined as chemicals that can migrate from the packaging into a drug product over the course of its shelf life.
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