Baiba Cabovska, Michael D. Jones, and Andrew Aubin
Waters Corporation (Milford, MA, USA)
About <br> for strict regulatory compliance in the pharmaceutical and food industries, packaging materials extractables 1-3 is one of the concerns of its container manufacturers and suppliers. 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 (UPC 2 ) 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). 14 kinds of commonly used polymer additives were screened extract, hexane, isopropyl alcohol (IPA) and water as the extraction solvent, n-hexane and GC-MS analysis IPA extract, ACQUITY UPLC ® apparatus using water and analysis IPA extracts were analyzed for all three solvent extracts using the ACQUITY UPC 2 unit and the UPC 2 analysis results were compared to GC and UPLC analysis results.
To download the full application note, please click: http://?cid=511436&lid=134714225&locale=zh_CN
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