Description

Colesevelam Hydrochloride is a non-absorbed, polymeric bile acid sequestrant specifically designed for pharmaceutical applications. This compound is critical for managing cholesterol levels by binding to bile acids in the intestine, forming a non-absorbable complex. It is an essential active pharmaceutical ingredient (API) primarily required by pharmaceutical manufacturers for the production of oral dosage forms targeting hypercholesterolemia and type 2 diabetes management.

Application

• Primary use as the Active Pharmaceutical Ingredient (API) in cholesterol-lowering medications.
• Formulation of solid oral dosage forms, specifically tablets, for the treatment of primary hyperlipidemia.
• Adjunctive therapy to improve glycemic control in adults with type 2 diabetes mellitus.
• Manufacturing of combination drug therapies for comprehensive cardiovascular risk management.
• Research and development (R&D) of novel gastrointestinal-targeted therapeutic agents.
• Use in clinical studies and pharmaceutical reference standards.

Basic Information

Product Name	Colesevelam Hydrochloride
CAS No.	182815-43-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Colesevelam HCl; 1-Hexanaminium, N,N,N-trimethyl-6-(2-propen-1-ylamino)-, chloride, polymer with (chloromethyl)oxirane and N-(2-propen-1-yl)-1-decanamine, hydrochloride; Cholestagel; Welchol (Trade Name); Bile Acid Sequestrant Polymer; GT31-104HB; Poly(allylamine) cross-linked polymer hydrochloride
EINECS	Contact for details

Quality Control

Our Colesevelam Hydrochloride is manufactured under strict quality systems suitable for pharmaceutical ingredient supply. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency. We provide full traceability and support regulatory filings. Certificates of Analysis (COA) documenting compliance with agreed specifications are available for every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be protected from humidity. Keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Assay (on dried basis)	98.0% - 102.0%
Loss on Drying	≤ 10.0%
Residue on Ignition	≤ 1.0%
Heavy Metals	≤ 20 ppm
Residual Solvents	Complies with ICH Q3C
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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