A mass balance method enables accurate determination of the purity of monosaccharides by incorporating the results obtained by various analytical techniques. High‐performance anion exchange chromatography with pulsed amperometric detection was used to quantify nonchromophoric impurities structurally related to the analyte. Organic acids as candidates of monosaccharide impurities were analyzed by ion chromatography with conductivity detection. Liquid chromatography with photodiode‐array UV detection was performed to detect other organic impurities. Karl‐Fischer coulometry with oven‐drying method was used to measure the water content in the samples. Finally, nonvolatile inorganic impurities were determined by thermal gravimetric analyses. The purities of the monosaccharides, glucose, galactose, fructose, and mannose, in kg/kg were (0.9983 ± 0.0004), (0.9962 ± 0.0005), (0.9999 ± 0.0004), and (0.9991 ± 0.0005), respectively. The mass balance method provides system of units (SI)‐traceable purity values, which can be applied to primary reference materials for assigning a certified value for the target monosaccharide in certified reference materials.

中文翻译：

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质量平衡法评估单糖的纯度

质量平衡法通过结合各种分析技术获得的结果，能够准确确定单糖的纯度。具有脉冲安培检测功能的高性能阴离子交换色谱用于定量分析与分析物结构相关的非发色杂质。通过电导检测的离子色谱法分析了作为单糖杂质候选物的有机酸。进行了带有光电二极管阵列紫外检测的液相色谱法以检测其他有机杂质。采用烤箱干燥法的卡尔·菲舍尔库仑法测量样品中的水分。最后，通过热重量分析法测定了非挥发性无机杂质。单糖，葡萄糖，半乳糖，果糖和甘露糖的纯度（kg / kg）为（0.9983±0.0004），（0.9962±0.0005），（0.9999±0.0004）和（0.9991±0.0005）。质量平衡方法提供了单位制（SI）可追溯的纯度值，可将其应用于主要参考材料，以为认证参考材料中的目标单糖分配认证值。