Abstract
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.
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