USPUSP-NF
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Sevelamer Carbonate for Oral Suspension

BRIEFING

 Sevelamer Carbonate for Oral Suspension. Because there is no existing USP monograph for this drug product, a new monograph based on validated test methods is proposed. The previous proposal published in PF 45(3) [May–Jun. 2019] was canceled and replaced with a new proposal.

  1. The liquid chromatographic procedure in the test for Limit of Allylamine is based on analyses performed using the J′Sphere ODS-H80 brand of column with L1 packing. The typical retention time for allylamine is about 7 min.

  2. The liquid chromatographic procedure in the test for Phosphate Binding Capacity is based on validation performed using the Metrosep A Supp brand of column with L132 packing. The typical retention time for phosphate ion is about 11.7 min.

 (SM2: S. Ramakrishna)

 Case ID—SUB-650; SUB-787

USP REFERENCE STANDARDS FOR PURCHASE

USP Polyallylamine Hydrochloride RS
USP Sevelamer Carbonate RS
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