BRIEFING
Sevelamer Carbonate Tablets. 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.
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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.
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The liquid chromatographic procedure in the test for Phosphate Binding Capacity is based on validation performed using the Ion Pac AS-11 brand of column with L61 packing. The typical retention time for phosphate ion is about 4 min.
(SM2: S. Ramakrishna)
Case ID—SUB-605; SUB-655; SUB-855