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Development of a new L-fucose purity certified reference material.

作者信息

Chen Weizhu, Fang Hua, Jin Wenhui, Chen Hui, Huang Xiaoyuan, Lin Zhichao, Hong Zhuan, Shi Guozong, Zhang Yiping

机构信息

Engineering Research Center of Marine Biological Resource Comprehensive Utilization,Third Institute of Oceanography, Ministry of Natural Resource, Xiamen, Fujian 361005, PR China; Xiamen Ocean Vocational College, Xiamen, Fujian 361100, PR China; Fujian Provincial Key Laboratory of Island Conservation and Development (Island Research Center, MNR), Pingtan, Fujian 350400, PR China.

Engineering Research Center of Marine Biological Resource Comprehensive Utilization,Third Institute of Oceanography, Ministry of Natural Resource, Xiamen, Fujian 361005, PR China; Xiamen Ocean Vocational College, Xiamen, Fujian 361100, PR China; Fujian Provincial Key Laboratory of Island Conservation and Development (Island Research Center, MNR), Pingtan, Fujian 350400, PR China.

出版信息

J Pharm Biomed Anal. 2025 Sep 15;263:116922. doi: 10.1016/j.jpba.2025.116922. Epub 2025 May 2.

Abstract

Certified Reference Materials (CRMs) with high accuracy and metrological traceability play an important role in calibrating equipment and validating analytical methods. L- fucose is a ubiquitous natural a six-carbon sugar that has many promising biological physiological functions. It can be used in medicine, food, healthcare products, cosmetics, and other fields. To accurately determine the content of L-fucose in various samples, a reliable CRM needs to be developed. In this study, an new L-fucose purity CRM was developed based on the ISO principle. The study included structural analysis, characterization, homogeneity test, stability evaluation, and uncertainties estimation. The mass balance (MB) and quantitative proton nuclear magnetic resonance (qH NMR) methods were used for characterizing the CRM. Using the MB method, main component, moisture, and nonvolatile and volatile impurities were measured. the PC of CRM was identified by performing high-performance liquid chromatography coupled with ultraviolet detection (HPLC-UV) using the pre-column derivatization procedure. L-fucose purity CRM was found to be stable for 18 months under ambient temperature conditions, whereas, 30 days at 50 °C. It was adequately homogeneous. At a 95 % confidence level, its certified value was 99.5 ± 1.2 % (k = 2).

摘要

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