Certification of a new certified reference material of honokiol

Abstract

Honokiol is the most important active pharmaceutical ingredient in Magnolia officinalis, which is a famous traditional Chinese medicine and commonly used in clinical practice. In order to control the quality of honokiol and related pharmaceuticals, a new certified reference material (CRM) of honokiol was developed. The studies of sample preparation, homogeneity, stability, value assignment, and uncertainty evaluation were accomplished in this paper. Three different methods, including differential scanning calorimetry (DSC), mass balance method (MB), and coulometric titration (CT), were employed to determine the purity of honokiol. Specifically, the DSC and CT methods for purity determination of honokiol were established for the first time. The purity of honokiol CRM, after validation and evaluation, was found to be 99.3%, with an expanded uncertainty of 0.5% (k = 2).