Extractables and leachables are substances that can move from packaging and permeate the drugs that are packaged inside them potentially degrading the product.
Extractables are compounds that move from a packaging contact surface in specific conditions, such as high temperatures, a long contact period or as a result of an overly aggressive solvent. It can include any component or device that is used to make a product that introduces degradants and residuals.
Leachables are compounds that migrate from a packaging contact surface under normal conditions. These compounds can include plastic components, coatings, accelerants, elastomers or anti-oxidants. This can also occur as a result from gamma sterilization of the product or the presence of solvents.
Studies are performed to optimize and customize packaging solutions for pharmaceutical products to ensure that containers are compatible with the item being stored in different storage conditions.