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Sucroferric Oxyhydroxide
FeHO2·xC12H22O11·y(C6H10O5)n Mixture of iron (III) oxyhydroxide, sucrose, and starches

BRIEFING

 Sucroferric Oxyhydroxide. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed. The liquid chromatographic procedure in the Assay for Sucrose and Starch was validated using the Nucleogel Sugar Ca brand of column with L19 packing. The typical retention times for sucrose and dextrose are about 8 and 10 min, respectively.

 Description and solubility information: Brown amorphous powder. The sucrose part is soluble in water; the polynuclear iron (III) oxyhydroxide and starch mixture is practically insoluble in water.

 (SM3: R. Muppa)

 Case ID—SUB-1343

USP REFERENCE STANDARDS FOR PURCHASE

USP Dextrose RS
USP Sucrose RS
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