Controlled Extraction Studies Applied to Polyvinyl Chloride and Polyethylene Materials: Conclusions from the ELSIE Controlled Extraction Pilot Study

摘要: The effective management of leachables in pharmaceutical products is a critical aspect their development. This can be facilitated if extractables information on the materials used packaging or delivery system available to assist companies selecting that will compatible with drug product formulation and suitable for intended use. Extractables Leachables Safety Information Exchange (ELSIE) working group developed executed comprehensive extraction study protocol included number solvents, techniques, variety analytical techniques. was performed two test materials, polyethylene (PE) polyvinyl chloride (PVC), were selected due common use packaging. purpose investigate could simplified such (i) reduced even single technique (ii) solvents obtain useful material selection regardless type. Results indicate that, at least PVC, reductions are feasible. Additionally, studies levels extractable elemental impurities low further confirm importance using orthogonal detection techniques gain adequate understanding profiles.