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通过定性分析、定值分析、均匀性检验、稳定性考察和不确定度评定,研制了维生素D3纯度标准物质。其中采用质量平衡法(包括液相色谱法、水分、灰分、挥发性物质和无机元素分析)、定量核磁共振法与差示扫描量热法3种不同原理的方法对维生素D3纯度标准物质进行了定值分析。准确的纯度定值结果为99.6%,扩展不确定度为0.6%。对于维生素D3的准确测定及相关疾病的正确诊断治疗具有重要意义。
Through the qualitative analysis, the fixed value analysis, the homogeneity test, the stability inspection and the uncertainty evaluation, the Vitamin D3 purity standard substance was developed. Among them, the methods of mass balance (including liquid chromatography, water, ash, volatile and inorganic elemental analysis), quantitative nuclear magnetic resonance and differential scanning calorimetry were used to measure the purity standards of vitamin D3 Value analysis. The accurate result of the purity setting is 99.6% and the expansion uncertainty is 0.6%. For the accurate determination of vitamin D3 and the correct diagnosis and treatment of related diseases is of great significance.