Development of a new certified reference material of diosgenin using mass balance approach and Coulometric titration method

• Diosgenin was developed as a new certified reference material.
• The CRM can be used to validate analytical methods, control the quality of diosgenin and pharmaceutical formulations.
• CT and mass balance methods were used to determine the purity of diosgenin for the first time.
• The certified value of diosgenin CRM is 99.80 ± 0.37% (k = 2).

Certified reference materials (CRMs) can be used as a valuable tool to validate the trueness of measurement methods and to establish metrological traceability of analytical results. Diosgenin has been selected as a candidate reference material. Characterization of the material relied on two different methods, mass balance method and Coulometric titration method (CT). The certified value of diosgenin CRM is 99.80% with an expanded uncertainty of 0.37% (k = 2). The new CRM of diosgenin can be used to validate analytical methods, improve the accuracy of measurement data and control the quality of diosgenin in relevant pharmaceutical formulations.

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