Identification and quantification by1H nuclear magnetic resonance spectroscopy of seven plasticizers in PVC medical devices.
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 using1H 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. Plasticizer1H 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 by1H 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.
Univ. Lille, CHU Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000, Lille, France.
Stéphanie
S
Genay
Univ. Lille, CHU Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000, Lille, France.
Frédéric
F
Feutry
Univ. Lille, CHU Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000, Lille, France.
Morgane
M
Masse
Univ. Lille, CHU Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000, Lille, France.
Christine
C
Barthélémy
Clermont Université, Université d'Auvergne, CHU Clermont-Ferrand, EA 4676, C-BIOSENSS, BP 10448, F-63000, Clermont-Ferrand, France.
Valérie
V
Sautou
Univ. Lille, CHU Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000, Lille, France.
Pascal
P
Odou
Univ. Lille, CHU Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000, Lille, France. Bertrand.decaudin@univ-lille2.fr.
Bertrand
http://orcid.org/0000-0001-8267-5594
B
Décaudin
Univ. Lille, CHU Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000, Lille, France.
Nathalie
N
Azaroual
D004864:Equipment and Supplies; D010968:Plasticizers / Q000737:chemistry*; D011143:Polyvinyl Chloride; D066244:Proton Magnetic Resonance Spectroscopy / Q000379:methods*
D010968:Plasticizers; D011143:Polyvinyl Chloride
Biomaterials; Medical devices; Nuclear magnetic resonance; Plasticizers; Polymers; Polyvinyl chloride