Description

Colesevelam CAS NO 182815-44-7 is a non-absorbed, polymeric bile acid sequestrant specifically designed for pharmaceutical applications. This compound is critical for managing cholesterol levels by binding bile acids in the intestine, interrupting their enterohepatic circulation. It is an essential active pharmaceutical ingredient (API) primarily required by pharmaceutical manufacturers for the production of prescription medications targeting hypercholesterolemia and type 2 diabetes.

Application

• Primary Pharmaceutical API: Core active ingredient in prescription medications for the treatment of primary hyperlipidemia.
• Type 2 Diabetes Adjunct Therapy: Used in combination with other therapies to improve glycemic control in adults.
• Bile Acid Sequestrant Formulations: Manufacture of oral tablets that bind bile acids in the gastrointestinal tract.
• Cholesterol-Lowering Drug Production: Serves as the key therapeutic component in anti-hypercholesterolemia drugs.
• Clinical Research & Development: Used as a reference standard and raw material in preclinical and clinical studies for metabolic disorders.
• Generic Drug Manufacturing: Sourcing of API for the production of bioequivalent generic versions of branded colesevelam medications.

Basic Information

Product Name	Colesevelam
CAS No.	182815-44-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Colesevelam Hydrochloride; Cholestagel; Welchol; GT 31-104; BAY 1663888; Poly(allylamine) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)trimethylammonium bromide; Poly(allylamine hydrochloride) N-alkylated with bromodecane and 6-bromohexyltrimethylammonium bromide
EINECS	Contact for details

Quality Control

Our Colesevelam is manufactured under strict quality systems suitable for pharmaceutical use. It undergoes rigorous analytical testing to ensure identity, purity, and potency meet stringent specifications. Certificates of Analysis (COA) are provided with each batch, detailing results from tests such as assay, impurity profiling, and residual solvents. We support compliance with major pharmacopeial standards and cGMP guidelines to ensure supply chain reliability for our global partners.

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. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 10.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 2.0%
Microbial Enumeration	Meets 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.