Development of a new L-fucose purity certified reference material

IF 3.1 3区医学 Q2 CHEMISTRY, ANALYTICAL

Journal of pharmaceutical and biomedical analysis Pub Date : 2025-05-02 DOI:10.1016/j.jpba.2025.116922

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

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引用次数: 0

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).

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一种新型L聚焦纯度认证标准物质的研制

具有高精度和计量可追溯性的标准物质在设备校准和分析方法验证中发挥着重要作用。L-焦糖是一种普遍存在的天然六碳糖，具有许多有前景的生物生理功能。可用于医药、食品、保健品、化妆品等领域。为了准确测定各种样品中L- focus的含量，需要开发可靠的CRM。本研究基于ISO原理开发了一种新的L聚焦纯度CRM。研究包括结构分析、表征、均匀性检验、稳定性评价和不确定度估计。采用质量平衡（MB）和定量质子核磁共振（q1h NMR）方法对CRM进行表征。采用MB法测定主要成分、水分、非挥发性和挥发性杂质。采用柱前衍生法进行高效液相色谱-紫外检测（HPLC-UV）鉴定。发现L聚焦纯度的CRM在室温条件下稳定18个月，而在50℃条件下稳定30天。它是充分齐次的。在95 %置信水平下，其认证值为99.5 ± 1.2 % （k = 2）。

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来源期刊

Journal of pharmaceutical and biomedical analysis 医学-分析化学

CiteScore

6.70

自引率

5.90%

发文量

588

审稿时长

37 days

期刊介绍： This journal is an international medium directed towards the needs of academic, clinical, government and industrial analysis by publishing original research reports and critical reviews on pharmaceutical and biomedical analysis. It covers the interdisciplinary aspects of analysis in the pharmaceutical, biomedical and clinical sciences, including developments in analytical methodology, instrumentation, computation and interpretation. Submissions on novel applications focusing on drug purity and stability studies, pharmacokinetics, therapeutic monitoring, metabolic profiling; drug-related aspects of analytical biochemistry and forensic toxicology; quality assurance in the pharmaceutical industry are also welcome. Studies from areas of well established and poorly selective methods, such as UV-VIS spectrophotometry (including derivative and multi-wavelength measurements), basic electroanalytical (potentiometric, polarographic and voltammetric) methods, fluorimetry, flow-injection analysis, etc. are accepted for publication in exceptional cases only, if a unique and substantial advantage over presently known systems is demonstrated. The same applies to the assay of simple drug formulations by any kind of methods and the determination of drugs in biological samples based merely on spiked samples. Drug purity/stability studies should contain information on the structure elucidation of the impurities/degradants.