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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 (q 1H 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). © 2025 Elsevier B.V.
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Journal of Pharmaceutical and Biomedical Analysis
ISSN: 0731-7085
Year: 2025
Volume: 263
3 . 1 0 0
JCR@2023
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ESI Highly Cited Papers on the List: 0 Unfold All
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30 Days PV: 0
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