USPUSP-NF
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Sevelamer Carbonate
[(C3H7N)a+b(C9H18N2O)c]n·xH2CO3 Carbonic acid, compound with (chloromethyl)oxirane polymer with 2-propen-1-amine;
 Poly(allylamine-co-N,N′-diallyl-1,3-diamino-2-hydroxypropane)carbonate salt [845273-93-0]

BRIEFING

 Sevelamer Carbonate. Because there is no existing USP monograph for this drug substance, a new monograph based on validated test methods is proposed. The proposal for this drug substance published in PF 45(2) [Mar.–Apr. 2019] was canceled and is replaced with a new proposal.

  1. The gas chromatographic procedure in the test for Limit of Epichlorohydrin is based on analyses performed using the RTX-5 brand of deactivated column with G27 phase. The typical retention time for the epichlorohydrin peak is about 4.5 min.

  2. 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 between 6 and 8 min.

  3. The liquid chromatographic procedure in the test for Phosphate Binding Capacity is based on validation performed using the IonPac AS-11 brand of column with L61 packing. The typical retention time for phosphate ion is between 5 and 8 min.

 Description and Solubility information: Sevelamer carbonate is a white to off-white powder; insoluble in water and in organic solvents.

 (SM2: S. Ramakrishna)

 Correspondence Number—C228515; C244115

USP REFERENCE STANDARDS FOR PURCHASE

USP Polyallylamine Hydrochloride RS
USP Sevelamer Carbonate RS
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