Purity and Uncertainty Study of CRM Betulin by DSC

Natural Products and Bioprospecting

Guan-Hua Du¹  De-Zhi Yang²  Yang Lu²  Li Zhang²  Peng-Hui Yuan²  Bao-Xi Zhang²  Fu-Qing Wang³  Bin Su⁴  Yan-Cai Bi⁴ 

[1] Beijing City Key Laboratory of Drug Target and Screening Research, National Center for Pharmaceutical Screening, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, 100050, Beijing, People’s Republic of China;Beijing City Key Laboratory of Polymorphic Drugs, Center of Pharmaceutical Polymorphs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, 100050, Beijing, People’s Republic of China;China Pharmaceutical Enterprises Association, 100044, Beijing, People’s Republic of China;Soteria Pharmaceutical Co., Ltd., 271100, Laiwu, People’s Republic of China;

关键词: Betulin;    DSC;    Purity determination;    Uncertainty study;   

DOI  :  10.1007/s13659-020-00261-1

来源: Springer

【 摘 要 】

Betulin (BE) can be obtained from many plants, such as those belonging Betulaceae family, and pharmacological investigations showed its notable biological properties and good potential for food and pharmaceutical development. We investigated the homogeneity, stability, purity, and uncertainty of a newly certified reference material (CRM) of BE. The certified purity value for the CRM of BE was 99.56% with an extended uncertainty of 0.07% (k = 2, P = 0.95), as determined by differential scanning calorimetry (DSC). In this study, DSC was used for the first time for purity determination of BE. Given its high accuracy, precision, and reproducibility, DSC can be used as an alternative technique for purity determination of CRMs in the pharmaceutical and food industry.Graphic abstract

【 授权许可】

CC BY