European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2026
Compatibility of PVC after irradiation: spectroscopic evaluation.
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Dorey Samuel, Girard Fabien, Dupuy Nathalie, Huart Celine, Marque Sylvain R A, Krieguer Blanche
Аннотация
Polyvinyl chloride (PVC) is extensively used in advanced therapies due to its flexibility, chemical resistance, and biocompatibility. This study investigates the equivalency of three ionizing radiation sterilization technologies (gamma rays, X-rays, and electron beam) at 50 and 100 kGy on three medical-grade PVC formulations. A comprehensive analytical approach combining Electron Spin Resonance (ESR), Fourier Transform Infrared Spectroscopy (FTIR), colorimetry, and High-Performance Liquid Chromatography (HPLC) was employed. ESR revealed persistent polyenyl radicals (up to 60 days) influenced by ageing rather than irradiation technology or dose. FTIR-PCA demonstrated dose-dependent carbonyl growth (1708 cm⁻¹) from additive oxidation whereas PVC backbone signatures remained stable. Statistical analysis established that differences among technologies remain within acceptable equivalence margins. These findings confirm that gamma, X-ray, and e-beam irradiation preserve the chemical integrity of PVC formulations for medical device applications.