Description

Sevelamer is a non-absorbed, phosphate-binding polymer used primarily as an active pharmaceutical ingredient (API). It is critical for the management of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. This compound is essential for pharmaceutical manufacturers developing oral solid dosage forms, such as tablets and capsules, to control serum phosphate levels effectively and safely.

Application

• Pharmaceutical API: Primary use as the active ingredient in medications for treating hyperphosphatemia.
• Tablet Formulation: Used in the production of chewable and film-coated tablets for patient compliance.
• Capsule Formulation: Incorporated into capsule dosage forms for oral administration.
• Renal Care Therapeutics: A key component in drugs for end-stage renal disease (ESRD) and CKD patients.
• Research & Development: Serves as a reference standard and starting material in pharmaceutical R&D for new renal therapies.
• Generic Drug Manufacturing: Used by generic pharmaceutical companies to produce bioequivalent sevelamer hydrochloride or carbonate products.

Basic Information

Product Name	Sevelamer
CAS No.	182683-00-7
Molecular Formula	(C3H7ClN)n • (C2H4O)m
Molecular Weight	Contact for details
Synonyms	Sevelamer Hydrochloride; Sevelamer Carbonate; Poly(allylamine-co-N,N'-diallyl-1,3-diamino-2-hydroxypropane) Hydrochloride; Renagel (Trade Name); Renvela (Trade Name); Poly(allylamine) cross-linked with epichlorohydrin; Poly(allylamine hydrochloride) cross-linked polymer; 2-Propen-1-amine, polymer with N-(2-propen-1-yl)-1,3-diamino-2-hydroxypropane, hydrochloride
EINECS	Contact for details

Quality Control

Our Sevelamer is manufactured under strict quality systems. It undergoes rigorous testing to ensure compliance with relevant pharmacopeial standards such as USP and EP. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing parameters including assay, identification, impurity profile, and residual solvents to guarantee its suitability as a pharmaceutical ingredient.

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). Due to its hygroscopic nature, the container must be kept tightly sealed to protect from moisture.

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
Residual Solvents	Complies with ICH Q3C
Microbial Enumeration	Complies with EP/USP

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