Identification and quantification of bisphenol A and bisphenol B in polyvinylchloride and polycarbonate medical devices by gas chromatography with mass spectrometry.
A gas chromatography with mass spectrometry method has already been developed and published for the identification and quantification of 14 phthalates and five nonphthalate plasticizers in polyvinylchloride medical devices. In order to assay, in addition to plasticizers, bisphenols A and B possibly present in polyvinylchloride samples, this previous method was extended to the assay of these additional potential endocrine disruptors. Furthermore, as bisphenol A could also be present in polycarbonate samples, the method used for the polyvinylchloride sample was tested and validated for the assay of bisphenols A and B in polycarbonate medical devices. The separation of all compounds, including bisphenols A and B, is obtained on a cross-linked 5%-phenyl/95%-dimethylpolysiloxane capillary column using a temperature gradient. For both plastics, samples are dissolved in tetrahydrofuran followed by a precipitation of the plastic by addition of ethanol. Results obtained point out residual bisphenol A amounts for polycarbonate samples ranging from 0.6 to 0.8% and for polyvinylchloride samples less or equal to 5 ppm. No bisphenol B was detected in the samples tested. For bisphenols A and B, mean recoveries obtained on spiked polyvinylchloride or polycarbonate sample preparations ranged from 87 to 108% in accordance with in-house specification (80-110%).
Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), Saint-Denis Cedex, France.
Pascal
P
Gimeno
Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), Saint-Denis Cedex, France.
Coline
C
Spinau
Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), Saint-Denis Cedex, France.
Nelly
N
Lassu
Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), Saint-Denis Cedex, France.
Annie-Françoise
AF
Maggio
Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), Saint-Denis Cedex, France.
Charlotte
C
Brenier
Agence nationale de sécurité du médicament et des produits de santé (ANSM), Direction des Contrôles (CTROL), Saint-Denis Cedex, France.
Laurent
L
Lempereur
D045784:Abietanes / Q000032:analysis; D001559:Benzhydryl Compounds / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004864:Equipment and Supplies; D008401:Gas Chromatography-Mass Spectrometry; D036145:Ginsenosides / Q000032:analysis; D008031:Lignin / Q000032:analysis; D010636:Phenols / Q000032:analysis*; D011076:Polycarboxylate Cement / Q000737:chemistry*; D011143:Polyvinyl Chloride / Q000737:chemistry*; D053719:Tandem Mass Spectrometry / Q000379:methods*; D000098923:Bisphenol B Compounds; D000098826:Bisphenol A Compounds
D045784:Abietanes; D001559:Benzhydryl Compounds; D036145:Ginsenosides; D008031:Lignin; D010636:Phenols; D011076:Polycarboxylate Cement; D011143:Polyvinyl Chloride; C021751:tanshinone; C492482:bisphenol B; D000098923:Bisphenol B Compounds; C005506:polycarbonate; C006780:bisphenol A; D000098826:Bisphenol A Compounds
Bisphenols; Gas chromatography with mass spectrometry; Medical devices; Phthalates; Plasticizers