Purity and Uncertainty Study of CRM Betulin by DSC

Nat Prod Bioprospect. 2020 Oct;10(5):317-324. doi: 10.1007/s13659-020-00261-1. Epub 2020 Aug 18.

Abstract

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.

Keywords: Betulin; DSC; Purity determination; Uncertainty study.