PRODUCT INFORMATION SEVELAMER CARBONATE WINTHROP NAME AUSTRALIAN Sevelamer carbonate CHEMICAL STRUCTURE The structure is presented in Figure 1. Figure 1 Structure of sevelamer carbonate The primary amine groups shown in the structure are derived directly from poly (allylamine hydrochloride). The cross - linking groups consist of two secondary amine groups derived from poly (allylamine hydrochloride) and one molecule of epichlorohydrin. Molecular Formula: (C3H7N.nH2CO3)810z (C9H18N2O.nH2CO3)95z where z = a large number Chemical Name: poly(allylamine-co-N,N’-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. CAS 845273-93-0 Sevelamer Carbonate Winthrop contains sevelamer, a non-absorbed phosphate binding polymer, free of metal and calcium. Sevelamer is a white to off-white powder comprising of a partial carbonate salt with approximately 40 % amine carbonate and 60 % free base. Sevelamer carbonate is amorphous, hygroscopic and hydrophilic, but insoluble in water with a pH range of 8-10.5 as a 1% aqueous slurry. Each Sevelamer Carbonate Winthrop film-coated tablet contains 800 mg of sevelamer carbonate on an anhydrous basis. Sevelamer Carbonate Winthrop tablets contain the following excipients:
PRODUCT INFORMATION SEVELAMER CARBONATE WINTHROP AUSTRALIAN NAME Sevelamer carbonate CHEMICAL STRUCTURE The structure is presented in Figure 1. Figure 1 Structure of sevelamer carbonate The primary amine groups shown in the structure are derived directly from poly (allylamine hydrochloride). The cross - linking groups consist of two secondary amine groups derived from poly (allylamine hydrochloride) and one molecule of epichlorohydrin. Molecular Formula: (C3H7N.nH2CO3)810z (C9H18N2O.nH2CO3)95z where z = a large number Chemical Name: poly(allylamine-co-N,N’-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. CAS 845273-93-0 Sevelamer Carbonate Winthrop contains sevelamer, a non-absorbed phosphate binding polymer, free of metal and calcium. Sevelamer is a white to off-white powder comprising of a partial carbonate salt with approximately 40 % amine carbonate and 60 % free base. Sevelamer carbonate is amorphous, hygroscopic and hydrophilic, but insoluble in water with a pH range of 8-10.5 as a 1% aqueous slurry. Each Sevelamer Carbonate Winthrop film-coated tablet contains 800 mg of sevelamer carbonate on an anhydrous basis. Sevelamer Carbonate Winthrop tablets contain the following excipients:
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