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.
Rights & PermissionsPrintExport