麦芽糖醇标准样品的研制

以市售麦芽糖醇为原料，采用制备高效液相技术，分离纯化获得纯度大于99%的麦芽糖醇样品。采用紫外光谱（UV）、红外光谱（IR）、质谱（MS）、核磁共振（NMR）等方法对化合物结构进行确证。采用高效液相色谱、薄层色谱和热重分析检测样品纯度。样品按照每瓶10 mg的规格进行分装，对分装后的样品进行了均匀性检验、稳定性检验和多个实验室联合定值。结果表明，麦芽糖醇样品的均匀性和稳定性良好，定值测定结果显示其纯度为99.64%，置信水平为95%的扩展不确定度为0.50%。该标准样品的研制符合GB/T 15000《标准样品工作导则》的要求，可用于麦芽糖醇及相关产品的含量测定、检测方法评定与质量控制。

Development of certified reference material of maltitol

Maltitol with the purity of over 99% was prepared by high-performance liquid chromatography (HPLC) from maltitol products available in the market. The structure of the purified product was confirmed by UV, IR, LC-MS, and NMR. The purity of the sample was determined by HPLC-ELSD, TLC and thermogravimetric analysis. The sample was separately packed according to a specification of 10 mg per bottle. Homogeneity and stability tests and cooperative certification were conducted by HPLC-ELSD. The results showed that the sample had good homogeneity and stability. The certified value of maltitol was 99.64% with an expanded uncertainty of 0.50% at a confidence level of 95%. The certified reference material of maltitol meets the requirements of the Directives for the Work of Reference Materials (GB/T 15000) and can be used for content determination, detection method evaluation, and quality control of maltitol and related products.