Description

Sevelamer is a crosslinked polymeric amine, specifically a poly(allylamine) hydrochloride, widely recognized as a non-absorbed phosphate-binding agent. Its primary commercial value lies in its ability to effectively manage hyperphosphatemia in patients with chronic kidney disease, offering a critical therapeutic option. This product is essential for pharmaceutical manufacturers producing oral medications, particularly for the renal care and nephrology sectors. We supply high-purity Sevelamer CAS NO 52757-95-6 to meet the stringent demands of global API and finished dosage form production.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active component in prescription medications for controlling serum phosphate levels in patients with end-stage renal disease (ESRD) on dialysis.
• Tablet and Capsule Formulation: Direct compression or encapsulation into solid oral dosage forms such as Renvela® (sevelamer carbonate) and Renagel® (sevelamer hydrochloride).
• Chronic Kidney Disease (CKD) Management: A cornerstone therapy for the long-term management of mineral and bone disorder (CKD-MBD) associated with kidney failure.
• Hyperphosphatemia Treatment: Binds to dietary phosphate in the gastrointestinal tract, preventing its absorption and helping to maintain healthy phosphate balance.
• Research & Development: Used in preclinical and clinical studies for investigating new renal therapeutics and combination therapies.
• Generic Drug Manufacturing: Serves as a key raw material for producers of generic sevelamer hydrochloride and carbonate formulations.

Basic Information

Product Name	Sevelamer
CAS No.	52757-95-6
Molecular Formula	(C3H7N)n•xHCl
Molecular Weight	Variable (Polymer)
Synonyms	Sevelamer Hydrochloride; Poly(allylamine hydrochloride) crosslinked; Poly(allylamine-co-N,N'-diallyl-1,3-diamino-2-hydroxypropane) hydrochloride; Poly(allylamine hydrochloride) epichlorohydrin cross-linked; Renagel (trade name); 2-Propen-1-amine, hydrochloride, polymer with N,N'-bis(2-propen-1-yl)-1,3-diamino-2-hydroxypropane; Poly(allylamine-co-N,N'-diallyl-1,3-diamino-2-hydroxypropane) HCl; Polyallylamine hydrochloride crosslinked with epichlorohydrin
EINECS	Contact for details

Quality Control

Our Sevelamer is manufactured under strict quality systems designed for pharmaceutical ingredients. Quality assurance includes comprehensive testing against relevant pharmacopeial standards (such as USP/EP monographs where applicable) for identity, assay, impurity profiles, and performance characteristics like phosphate binding capacity. Each batch is supported by a detailed Certificate of Analysis (COA), ensuring traceability and compliance with cGMP guidelines for API production.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed to prevent absorption of atmospheric moisture, which can affect performance and stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Assay (on dried basis)	Contact for details
Loss on Drying	≤ 10.0 %
Residue on Ignition	≤ 2.0 %
Heavy Metals	≤ 20 ppm
Phosphate Binding Capacity	Contact for details
Microbial Limits	Meets requirements

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.