Determination and uncertainty estimation of tangeretin purity certified reference material

Abstract

Certified reference materials (CRMs) with high accuracy and traceability are essential tools for validation of analytical methods and calibration of equipment. They are widely used in various fields and have an important role in analytical science. In this study, tangeretin purity certified reference material was first developed in compliance with the principles of ISO guides. The investigation included preparation, characterization, homogeneity test, stability study and uncertainty estimation. In the characterization, mass balance method (MB) and differential scanning calorimetry (DSC) were simultaneously utilized, which would make up for the deficiency of a single method and cross-check the determination results. The mass balance method involved measurement of main component, as well as moisture, volatile impurities and inorganic impurities. Homogeneity, together with short-term and long-term stability, was investigated and the uncertainty estimation was performed. The results showed that tangeretin CRM was sufficiently homogeneous and stable for 12 months at 4 °C. The certified value is 99.8%, and the expanded uncertainty is 0.1% (k = 2).