Shandong Science ›› 2020, Vol. 33 ›› Issue (3): 45-52.doi: 10.3976/j.issn.1002-4026.2020.03.007

• Traditional Chinese medicine and natural active products • Previous Articles     Next Articles

Development of certified reference material of maltitol

DUAN Wen-juan, LI Yue, GENG Yan-ling, WANG Xiao   

  1. Qilu University of Technology (Shandong Academy of Sciences), Shandong Analysis and Test Center, Shandong 
    Provincial Key Laboratory of TCM Quality Control Technology, Jinan 250014, China
  • Online:2020-05-29 Published:2020-06-01

Abstract: 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.

Key words: maltitol, certified reference material, homogeneity, stability, certification, uncertainty

CLC Number: 

  • R284.1