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开发纯度认证标准物质,为农产品中硝基咪唑类化合物的测量建立计量溯源性。

Development of purity certified reference materials to establish metrological traceability for the measurement of nitroimidazoles in agricultural products.

机构信息

Key Laboratory of Agro-Food Safety and Quality, Ministry of Agriculture and Rural Affairs, Institute of Quality Standard and Testing Technology for Agro-Products, Chinese Academy of Agricultural Sciences, Beijing, 100081, China.

出版信息

Anal Bioanal Chem. 2024 Nov;416(28):6437-6449. doi: 10.1007/s00216-024-05530-3. Epub 2024 Sep 19.

Abstract

It is of significant importance to public health that reliable monitoring of nitroimidazoles be conducted, while certified reference materials (CRMs) are essential for accurate and reliable detection. A project has been initiated with the objective of developing nitroimidazole purity CRMs to ensure that results from nationwide monitoring laboratories for nitroimidazoles in antibiotic residues can be compared and traced. The candidates were successively characterized in terms of their structure by means of infrared (IR) spectroscopy and mass spectrometry (MS). The mass balance (MB) method and the quantitative nuclear magnetic resonance (qNMR) method were utilized to determine the purity of nitroimidazoles with remarkable accuracy. Furthermore, a methodical investigation was conducted on homogeneity, stability, and uncertainty. Six nitroimidazole purity CRMs, including tinidazole (GBW09252), secnidazole (GBW09286), ronidazole (GBW09288), metronidazole (GBW(E)090755), dimetridazole (GBW(E)090819), and ornidazole (GBW(E)090820), were finally manufactured following authorization from China's State Administration for Market Regulation (SAMR). By using these CRMs, it is possible to improve the traceability, accuracy, and comparability of nitroimidazole measurements in a range of agricultural products, protecting public health.

摘要

建立可靠的监测硝基咪唑类药物的方法对公共卫生具有重要意义,而有证标准物质(CRM)是准确可靠检测的基础。本项目旨在开发硝基咪唑纯度 CRM,以确保全国抗生素残留硝基咪唑监测实验室的结果具有可比性和可追溯性。通过红外(IR)光谱和质谱(MS)对候选物进行了结构分析。利用质量平衡(MB)法和定量核磁共振(qNMR)法可准确测定硝基咪唑的纯度。此外,还对均匀性、稳定性和不确定性进行了方法学研究。最终,在中国国家市场监督管理总局(SAMR)的授权下,生产了 6 种硝基咪唑纯度 CRM,包括替硝唑(GBW09252)、塞克硝唑(GBW09286)、罗硝唑(GBW09288)、甲硝唑(GBW(E)090755)、二甲硝唑(GBW(E)090819)和奥硝唑(GBW(E)090820)。这些 CRM 的使用可以提高农产品中硝基咪唑类药物测量的可溯源性、准确性和可比性,从而保护公众健康。

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