关键词: 1,4-丁二醇二缩水甘油醚, 标准物质, 医疗器械, 气相色谱

Abstract: OBJECTIVE：To prepare 1,4-butanediol diglycidyl ether (BDDE) as a reference material for the detection of medical products. METHODS：Raw materials were screened and evaluated by gas chromatography-mass spectrometry，infrared spectroscopy，nuclear magnetic resonance spectroscopy and carbon spectroscopy. Its purity was checked by the mass balance method，and its content in organic components was checked by the gas chromatography area normalization method. The purity was also determined by the mass balance method，and the content by the gas chromatography 1% self-control method. Its uniformity and stability were investigated，and uncertainty was evaluated. In addition，the purity of BDDE was determined using three analytical instruments：gas chromatograph，gas chromatograph-mass spectrometer and liquid chromatograph-mass spectrometer；three solvents：acetone，water and ethyl acetate；and three quantitative methods：1% self-control method，area normalization method and external standard curve method. RESULTS：The purity of the acquired BDDE reference material was (98.14±0.21)%，and the accurate value of the fixed value was stable. The homogeneity was evaluated by one-way analysis of variance，F=1.137<F_0.05(14，30)，P>0.05，and it was considered that the standard substance to be tested was uniform within the 95% confidence interval. The short-term stability test results showed that it was stable at room temperature and at -18~-22 ℃ for 14 days，and the long-term stability was stable for 6 months. In addition，different instruments，solvents and methods had no significant effect on the measurement results，and the accuracy of the fixed value results of BDDE solution was verified. CONCLUSION：The acquired BDDE reference material showed accurate value，low uncertainty，good uniformity and stability，and can poteenteially be used for detection of medical products.

Key words: 1,4-butanediol diglycidyl ether, standard material, medical devices, gas chromatography