Abstract

Cyclovirobuxine D is an active steroid alkaloid distributed in Buxus microphylla and applied in therapeutic practice of cardiovascular disease. This study describes the development of a new CRM, which includes the homogeneity assessment, stability assessment, purity determination, and uncertainty evaluation. DSC method was applied to the value assignment of cyclovirobuxine D for the first time. The certified purity value for the CRM of cyclovirobuxine D is 996.6 mg•g-1 with an extended uncertainty of 0.6 mg•g-1 (k = 2, P = 0.95) by DSC method. The CRM of cyclovirobuxine D can be widely used to quantitative analyses of cyclovirobuxine D and other related pharmaceutical formulations.

Keywords: Cyclovirobuxine D, DSC, value assignment, uncertainty evaluation, CRM, homogeneity study, stability study.

Graphical Abstract