Development of a Pure Certified Reference Material of D-Mannitol

oleh: Weizhu Chen, Yiping Zhang, Hui Chen, Wenhui Jin, Xiaoying Chen, Xiaoyan Huang, Yanrou Xie, Hua Fang, Zhuan Hong

Format: Article
Diterbitkan: MDPI AG 2023-09-01

Deskripsi

A new certified reference material (CRM) of D-mannitol (GBW(E) 100681) has been developed in this study. We describe the preparation, structure determination, characterization, homogeneity study, stability study, as well as uncertainty estimation. The main component was 99.91% ± 0.01%. The moisture content of the candidate CRM was 0.036% ± 0.002%, as measured by Karl Fischer titration. The nonvolatile and volatile impurities in the candidate CRM were all much less than 0.01%, which was determined by the ICP–MS and headspace GC–FID methods, respectively. The purity of the D-mannitol CRM was 99.9% ± 1.1% (<i>k</i> = 2), as measured by the two independent approaches involving the mass balance method (MB) and quantitative nuclear magnetic resonance technique (<i>q</i>NMR). The D-mannitol CRM was stable during the monitoring period for each temperature. It is stable for up to 48 months at room temperature and 28 days at 50 °C. The uncertainty was evaluated by combining the contributions from characterization, homogeneity, and stability. The developed D-mannitol CRM would effectively support method validation and proficiency testing, as well as effectively guarantee the accuracy, reliability, and comparability of results.