Determination for residual of 1,4-Butanediol from medical device based on polyurethane by GC-MS/MS
A method for determining the amount of 1,4-butanediol(BDO)residues in polyurethane(TPU)material for medi-cal devices using gas chromatography-tandem triple quadrupole mass spectrometry(GC-MS/MS)was established.After ex-traction,dissolution and filtration of mixed solvents,the samples were determined by VF-WAXms capillary column column(30 m×0.25 mm×0.25 μm)as the analytical column,and the triple quadrupole mass spectrometry of the EI ionization source was determined in the selected ion detection scanning mode(SIM mode),and the external standard was quantified.The re-sults showed that the method had a good linear relationship in the concentration range of 5 μ.g/mL-100 μg/mL(R≥0.999 5),and the detection limit was 0.10 μg/kg(S/N=3).The average recovery rate at the three spike levels was 99.79％-103.61％(n=6),and the relative standard deviation was 1.23％-3.45％.This method provides technical support for the determination of BDO residue in polyurethane materials for medical devices.
万方数据
维普
