Polymeric materials are widely used in the pharmaceutical industry to manufacture medical devices. During storage or use, chemicals might leach from these materials into the pharmaceutical product and affect the drug efficacy and/or safety. Extraction and Leachable (E&L) studies are now a crucial component of product release. The extractables study identifies species from the packaging system that could migrate into the pharmaceutical product upon storage under normal conditions. The extraction from polymers has been traditionally performed by Soxhlet extraction or boiling under reflux. These methods typically are time-consuming and require large volumes of solvent. Accelerated solvent extraction (ASE) is a pressurized fluid extraction (PFE) technique that uses organic solvents at high pressures; and therefore, temperatures above the solvent’s boiling point can be used, resulting in increased efficiency and reduction of extraction times. ASE is recommended by the PQRI and USP&lt;1663&gt; as one of the analytical techniques for extractables testing. The Thermo ScientificTM EXTREVATM ASETM Accelerated Solvent Extractor is a system based on many proprietary technologies including gas assisted solvent delivery technology and parallel accelerated solvent extraction. This fully automated system combines the extraction and evaporation capabilities in one instrument, and it can be conveniently used for extracting and concentrating/drying compounds from up to 16 solid and semi-solid samples. This system can use up to six different extraction solvents (or mixtures of them) and extract up to four cells in parallel. This work demonstrates the successful use of the fully automated EXTREVA ASE system for the extraction of plastic additives in packaging. Additives were confidently identified by liquid chromatography and Orbitrap-based high-resolution accurate mass (HRAM) mass analysis. The EXTREVA ASE technique delivers comparable or more efficient extractions than the traditional 10 h static liquid extraction. The EXTREVA ASE system combines extraction and evaporation in one unit, which significantly reduces manual labor cost and increases sample throughput.

Identification of plastic additives in pharmaceutical packaging using a fully automated parallel extraction evaporator system and UHPLC-HRMS

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