Study of National Primary Purity Certified Reference Material of Tropisetron Hydrochloride

OBJECTIVE To develop the national primary purity certified reference material(CRM) of tropisetron hydrochloride which has measurement traceability and value transfer function through establishing accurate, reliable analytical method of valuation and uncertainty. METHODS The 5-HT₃ receptor antagonist tropisetron hydrochloride was used as the study object. The homogeneity and the stability were checked by HPLC. The purity of tropisetron hydrochloride CRM was certified by the joint certification including HPLC and differential scanning calorimetry, and the uncertainty was carefully evaluated on the basis of Technical Norm of Primary Reference Material and related documents requirements. RESULTS Tropisetron hydrochloride CRM showed satisfactory homogeneity and stability. The purity of tropisetron hydrochloride CRM was 99.7% and the uncertainty was 0.4%(k=2). CONCLUSION The national primary CRM of tropisetron hydrochloride developed has been assigned as a grade primary reference material(GBW09494). The study enables measurement traceability and value transfer of related components, as well as provides important reference material and standard analysis methods for the standardization and modernization of medicines.