Sodium Monofluorophosphate (MFP) is one of the active ingredients approved by the U.S. Food and Drug Administration (FDA) for use in toothpaste to prevent tooth decay. As part of the United States Pharmacopeia (USP) modernization effort, an ion chromatography (IC) method has been proposed to replace a precipitation procedure for identification and a titration-based procedure for assay in the Sodium Monofluorophosphate monograph. In the proposed monograph revision the IC method is used to assay the monofluorophosphate, identify monofluorophosphate based on its retention time, and to test the limit of fluoride. The proposed IC method uses a Thermo Scientific™ Dionex™ IonPac™ AS18 anion-exchange column with L113 packing and suppressed conductivity detection. Here we evaluate this method following the guidelines outlined in USP General Chapter &lt;1225&gt;, Validation of Compendial Methods. The Thermo Scientific™ Dionex™ IonPac™ AS18-4µm (2mm), which is an allowed replacement based on USP General Chapter &lt;621&gt; Chromatography, was used in the study.  This presentation will review this evaluation. We found the method is linear, ranging from 0.2 to 300 mg/mL, sensitive, accurate, precise, and robust for the determination of sodium monofluorophosphate in toothpaste.

Determination of sodium monofluorophosphate in toothpaste using ion chromatography

2019 Spring National Meeting

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