For the pharmaceutical and food industries with strict regulatory compliance, extractables in packaging materials are one of the concerns of their container manufacturers and suppliers 1-3. Due to the requirements of these regulations, packaging material manufacturers actively control and monitor their products to ensure that their extractables and leachables do not pose a risk. Similarly, industrial process manufacturers such as plastic containers and filters are required to prove that their products have not added any leachables during the manufacturing process.
Therefore, controlled extraction studies were conducted at the outset to qualitatively and quantitatively study extractables characteristics from critical container containment system components. The study was conducted in the early stages of equipment and packaging development using solvent extraction techniques, including a range of polar, solvent compatibility studies and various analytical techniques. One of the bottlenecks encountered in these studies is the matching problem between solvent extracts and suitable analytical techniques, such as non-polar solvent extracts that can be directly injected into gas chromatography (GC) analysis, and liquid chromatography (LC) analysis. It must be evaporated to dryness and reconstituted into a compatible solvent. Similarly, the aqueous extract must be stripped into a non-polar solution for analysis by GC. Ultra-High Performance Convergence Chromatography (UPC2) is an analytical system based on the principle of supercritical fluid chromatography (SFC) that allows direct injection of extracts of different solvent types, thus saving time and reducing sample preparation.
In this application note, four different packaging materials were extracted, including high density polypropylene vials (HDPE), low density polypropylene bottles (LDPE), ethylene vinyl acetate plastic bags (EVA), and polychlorinated chlorine. Vinyl transparent material (PVC). Screening of 14 common polymer additives in the extract, using n-hexane, isopropanol (IPA) and water as extraction solvents, GC-MS analysis of n-hexane and IPA extracts, analysis of water and IPA using the ACQUITYUPLC® unit The extracts were analyzed for all three solvent extracts using the ACQUITY UPC2 unit and the UPC2 analysis results were compared to GC and UPLC analysis results.