Journal
ANALYTICAL AND BIOANALYTICAL CHEMISTRY
Volume 409, Issue 5, Pages 1271-1280Publisher
SPRINGER HEIDELBERG
DOI: 10.1007/s00216-016-0053-4
Keywords
Nuclear magnetic resonance; Plasticizers; Polyvinyl chloride; Medical devices; Biomaterials; Polymers
Funding
- French Medicine Agency (ANSM, Agence Nationale de Securite du Medicament et des Produits de Sante)
- Region Nord-Pas de Calais (France)
- Ministere de la Jeunesse, de l'Education Nationale et de la Recherche (MJENR)
- Fonds Europeens de Developpement Regional (FEDER)
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Medical devices are generally made of polyvinyl chloride plasticized by six authorized plasticizers as alternatives to di-(2-ethylhexyl)-phthalate (DEHP) classified as reprotoxic class 1b. These are acetyl tri-n-butyl citrate (ATBC), di-(2-ethylhexy) adipate (DEHA), di-(2-ethylhexyl) terephthalate (DEHT), di-isononyl cyclohexane-1,2-dicarboxylate (DINCH), di-isononyl phthalate (DINP), and tri-octyl trimellitate (TOTM). The main objective of this study was to propose a new method using H-1 NMR spectroscopy to determine and quantify these seven plasticizers in PVC sheets, standard infusion tubings, and commercially available medical devices. Two techniques were compared: dissolution in deuterated tetrahydrofuran and extraction by deuterated chloroform. Plasticizer H-1 NMR spectra were very similar in both deuterated solvents; dissolution and extraction provided similar results. The sensitivity of this method enabled us to detect and quantify the presence of minor plasticizers in PVC. In nine commercially available samples, the major plasticizer was identified and quantified by H-1 NMR. In six samples, one, two, or three minor plasticizers were identified and also quantified. DEHP was detected in only one tubing. NMR is therefore very convenient for studying plasticizers contained in medical devices. Only small quantities of solvents and sample are required. It is not necessary to dilute samples to enter a quantification range, and it is sufficiently sensitive to detect contaminants.
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