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Baiba Cabovska, Michael D. Jones, and Andrew Aubin
Waters Corporation (Milford, MA, USA)
Introduction
For the pharmaceutical and food industries with strict regulatory compliance, extractables in packaging materials are one of the concerns of 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 leachable substances do not cause risks. Similarly, industrial processing manufacturers such as plastic containers and filters are required to prove that their products do not add any leachables during the production process.
Therefore, at the beginning, controlled extraction studies will be carried out to qualitatively and quantitatively study the characteristics of extractables from key container closure system components. The research was conducted in the early stages of equipment and packaging development, and the test used solvent extraction techniques, including a series of polarities, solvent compatibility studies, and multiple analytical techniques. One of the bottlenecks encountered in these studies is the matching problem between solvent extracts and appropriate analytical techniques. For example, non-polar solvent extracts can be directly injected into gas chromatography (GC) analysis; while liquid chromatography (LC) analysis, It must be evaporated and reconstituted in a compatible solvent. Similarly, the water extract must be back extracted into a non-polar solution before it can be analyzed by GC. Ultra High Performance Convergence Chromatography (UPC2) is an analysis system based on the principle of Supercritical Fluid Chromatography (SFC), which can directly inject and analyze 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 medicine bottles (HDPE), low-density polypropylene bottles (LDPE), ethylene-vinyl acetate plastic bags (EVA) and polyvinyl chloride Vinyl transparent material (PVC). Screening of 14 common polymer additives in extracts, using n-hexane, isopropyl alcohol (IPA) and water as extraction solvents, using GC-MS to analyze n-hexane and IPA extracts, and using ACQUITY UPLC® device to analyze water and For the IPA extract, use the ACQUITY UPC2 device to analyze all three solvent extracts and compare the UPC2 analysis results with GC and UPLC analysis results.
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