Development of a Pure Certified Reference Material of D-Mannitol

Area of Science:

• Analytical Chemistry
• Materials Science
• Metrology

Background:

• Certified Reference Materials (CRMs) are crucial for ensuring the accuracy and comparability of analytical measurements.
• D-mannitol is a widely used compound in various applications, necessitating a reliable reference standard.

Purpose of the Study:

• To develop and characterize a new certified reference material (CRM) for D-mannitol.
• To establish the purity, homogeneity, and stability of the D-mannitol CRM.
• To provide a reliable standard for analytical method validation and proficiency testing.

Main Methods:

• Preparation and structure determination of D-mannitol.
• Characterization using Karl Fischer titration, ICP-MS, and headspace GC-FID.
• Purity assessment via mass balance (MB) and quantitative nuclear magnetic resonance (qNMR).
• Homogeneity and stability studies at various temperatures.
• Uncertainty estimation combining multiple contributions.

Main Results:

• The main component purity of the D-mannitol CRM was determined to be 99.91% ± 0.01%.
• Moisture content was 0.036% ± 0.002%, with impurities below 0.01%.
• Overall purity was established as 99.9% ± 1.1% (k=2) using two independent methods.
• The CRM demonstrated stability for up to 48 months at room temperature and 28 days at 50 °C.

Conclusions:

• A new D-mannitol CRM (GBW(E) 100681) has been successfully developed and characterized.
• The established purity, stability, and low uncertainty make it suitable for its intended applications.
• This CRM will enhance the accuracy, reliability, and comparability of D-mannitol measurements in analytical laboratories.