Identification and quantification by 1H nuclear magnetic resonance spectroscopy of seven plasticizers in PVC medical devices.

Archive ouverte

Genay, Stéphanie | Feutry, Frédéric | Masse, Morgane | Barthélémy, Christine | Sautou, Valérie | Odou, Pascal | Décaudin, Bertrand | Azaroual, Nathalie | Group, Armed Study

Edité par CCSD ; Springer Verlag -

International audience. 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 1H 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 1H 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 1H 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.

Consulter en ligne

Suggestions

Du même auteur

How to solve the problem of co-elution between two compounds in liquid chromatography through the first UV derivative spectrum. A trial on alternative plasticizers to di(2-ethylhexyl) phthalate.

Archive ouverte | Masse, Morgane | CCSD

International audience. To meet new regulations, alternative plasticizers to di(2-ethylhexyl) phthalate (DEHP) are now commonly used in the manufacturing of medical devices. These are: acetyl tri-n-butyl citrate (AT...

Long-term stability of ready-to-use 1-mg/mL midazolam solution.

Archive ouverte | Gilliot, Sixtine | CCSD

International audience. PurposeMidazolam is a benzodiazepine derivative commonly used in intensive care units to control sedation. Its use requires dilution of a 5-mg/mL commercial solution to a target concentration...

To what extent do the storage conditions of polyether‐based polyurethane have an impact on diazepam delivery?. To what extent do the storage conditions of polyether-based polyurethane have an impact on diazepam delivery?

Archive ouverte | Maiguy‐foinard, Aurélie | CCSD

International audience. Interactions between medical device material and the drug itself have been evoked for polyurethane and may lead to underdosing. Polyurethane, sterilization mode, and the crosslinking level of...

Chargement des enrichissements...