Identification and quantification of 14 phthalates and 5 non-phthalate plasticizers in PVC medical devices by GC-MS.
A GC/MS method was developed for the identification and quantification of 14 phthalates: 8 phthalates classified H360 (DBP, DEHP, BBP, DMEP, DnPP, DiPP, DPP and DiBP), 3 phthalates proposed to be forbidden in medical devices (DnOP, DiNP and DiDP) and 3 other phthalates none regulated (DMP, DCHP and DEP) which may interfere with hormone function. In order to identify and quantify other plasticizers that are commonly used in PVC medical devices such as DEHP substitute, 5 non-phthalate plasticizers (ATBC, DEHA, DEHT, TOTM, and DINCH) were included in this study. Analyses are carried out on a GC/MS system with electron impact ionization mode (EI). The separation of plasticizers is obtained on a cross-linked 5%-phenyl/95%-dimethylpolysiloxane capillary column 30m×0.25mm (i.d.)×0.25μm film thickness using a gradient temperature. Compounds quantification is performed by external calibration using an internal standard. Validation elements on standard solutions were determined using the ISO 12787 standard approach. Plasticizers are extracted from PVC medical devices using THF for dissolving the PVC part of the sample followed by precipitation of the PVC by addition of ethanol. The supernatant is injected into a GC/MS system after dilution in ethanol. Different validation elements, including extraction recoveries for all compounds or for DEHP a cross-validation of the extraction process using the European pharmacopoeia monograph 3.1.14 as reference method, are discussed. Results obtained on 61 medical devices in PVC and 12 raw materials used as plasticizers are given.
Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), 635 rue de la Garenne, 34740 Vendargues, France. Electronic address: pascal.gimeno@ansm.sante.fr.
Pascal
P
Gimeno
Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), 635 rue de la Garenne, 34740 Vendargues, France.
Sébastien
S
Thomas
Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), 635 rue de la Garenne, 34740 Vendargues, France.
Claudine
C
Bousquet
Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), 635 rue de la Garenne, 34740 Vendargues, France.
Annie-Françoise
AF
Maggio
Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), 635 rue de la Garenne, 34740 Vendargues, France.
Corinne
C
Civade
Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), 635 rue de la Garenne, 34740 Vendargues, France.
Charlotte
C
Brenier
Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), 635 rue de la Garenne, 34740 Vendargues, France.
Pierre-Antoine
PA
Bonnet
D004864:Equipment and Supplies / Q000592:standards*; D008401:Gas Chromatography-Mass Spectrometry / Q000379:methods*; D010795:Phthalic Acids / Q000032:analysis* / Q000737:chemistry / Q000145:classification; D010968:Plasticizers / Q000032:analysis* / Q000737:chemistry / Q000145:classification; D011143:Polyvinyl Chloride; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D010795:Phthalic Acids; D010968:Plasticizers; D011143:Polyvinyl Chloride
Gas chromatography–mass spectrometry; ISO 12787; Medical devices; Phthalates; Plasticizers