The suitability of a packaging system for use must be established through chemical testing to evaluate the packaging system materials. The first step in this assessment is to follow USP <661.2> Plastic Packaging Systems for Pharmaceutical Use. Depending on the risk level of the dosage form and its clinical use, further chemical testing may be needed. A more in-depth chemical assessment would include an extractables and leachables study.
Extractables & Leachables - Drug Products
An extractables study includes extraction of the packaging component material with neat solvents, followed by instrumental analysis . This produces an Extractables Profile, which represents the “landscape” of all compounds in the material that could leach into the drug product. This testing is performed following USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery SystemsA. The resulting profile is then used to develop a leachables target list. Methods are developed and validated to analyze the drug product on stability for the presence of any leachables over the shelf life of the drug product. Leachables testing is performed following USP <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems. The results of this leachables study are then assessed by a toxicologist to ensure all leachables compounds are present at safe levels to the patient.