Migration of additives from poly(vinyl chloride) (PVC) tubes into aqueous media

The stability and migration product of medical PVC tubes plasticized with polyadipates were investigated by ageing in phosphate buffer at pH 1.679 and water at different temperatures. Changes in the PVC tubes were studied by wtaer absorption, weight loss, Fourier infrared spectroscopy (FTIR), differential scanning calorimetry (DSC) and thermal gravimetric analysis (TGA). The low molecular weight migration product that was released was extracted and silylanized before gas chromatography/mass spectroscopy (GC/MS) identification and quantification. After 70 days, the weight loss was less than 0.5% and only a small amount of adipic acid migrated when a tube was aged at 37 C in water and phosphate buffer (pH 1.679), and at 70 C in water after 56 days. However, when aged at 70 and 110 C, gradual deactivation of heat stabilizer after 21 days of ageing in buffer solution and separation of plasticizer from PVC matrix occurred. When the tube was aged at 110 C, significant degradation of both polyadipates and PVC were observed. Adipic acid and 1,4-butanediol monomers and oligomers of polyadipate were the major migration products from polyadipates in the water ageing solution, while only a relatively high amount of adipic acid was identified as the main product in the buffer ageing solution