Li Zhang, Yang Lu, Yonghui Guo, Wei Xu, Guimin Jin and Guanhua Du Pages 568 - 572 ( 5 )
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.
Cyclovirobuxine D, DSC, value assignment, uncertainty evaluation, CRM, homogeneity study, stability study.
Center of Pharmaceutical Polymorph, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P.R. China.