AN72926: Sodium Monofluorophosphate Monograph Modernization using Ion Chromatography
DescriptionSodium monofluorophosphate (MFP) is approved by the FDA as an anti-caries agent in toothpastes and mouth rinses. MFP can hydrolyze to free fluoride and phosphate during storage. It is important to determine fluoride and MFP in MFP solid and in toothpastes to evaluate API and drug product quality and stability. An IC method has been proposed to replace existing titration-based assays in the MFP monograph. The IC method used an anion-exchange column with suppressed conductivity detection. This application validated the IC method and demonstrated using it to determine MFP in a toothpaste.
|Keywords:||Drug Substance, Pharmaceutical, USP monograph, RFIC, MFP, Toothpaste, suppressed conductivity detection, Reagent-Free IC, Assay, Dionex IonPac AS18 column, impurity limit, mouth wash|
|Author:||Hua Yang and Jeffrey Rohrer|
|Affiliation:||Thermo Fisher Scientific|
For Research Use Only. Not for use in diagnostic procedures.