Description

Colestipol Hydrochloride is a high-molecular-weight, basic anion exchange resin used primarily as a cholesterol-lowering agent. This pharmaceutical-grade compound is critical for formulating bile acid sequestrants that effectively manage hypercholesterolemia and reduce the risk of cardiovascular disease. It is essential for manufacturers in the global pharmaceutical industry developing solid oral dosage forms, such as tablets and capsules, for lipid regulation therapies.

Application

• Pharmaceutical Active Ingredient (API): Primary use as a lipid-lowering agent in prescription medications for hypercholesterolemia.
• Bile Acid Sequestrant Formulations: Key component in drugs that bind bile acids in the intestine, interrupting the enterohepatic circulation.
• Oral Solid Dosage Forms: Used in the production of tablets, capsules, and other solid formulations for cholesterol management.
• Cardiovascular Disease Prevention: Integral to preventative drug therapies aimed at reducing LDL cholesterol and coronary heart disease risk.
• Research & Development: Serves as a reference standard and raw material in pharmacokinetic and pharmacodynamic studies.
• Generic Drug Manufacturing: A vital API for producing cost-effective generic versions of established cholesterol-lowering drugs.

Basic Information

Product Name	Colestipol Hydrochloride
CAS No.	37296-80-3
Molecular Formula	(C6H15Cl2N)n • xHCl
Molecular Weight	High molecular weight polymer (Contact for details)
Synonyms	Colestipol HCl; 1,2-Ethanediamine, N-(2-aminoethyl)-, polymer with (chloromethyl)oxirane, hydrochloride; Poly[2-(diethylamino)ethyl glycidyl ether-co-ethylene glycol] hydrochloride; Colestid (trade name); Cholestabyl; DEAE-Sephadex derivative; Anion exchange resin, weakly basic; Polyamine polymer hydrochloride
EINECS	Contact for details

Quality Control

Our Colestipol Hydrochloride is manufactured under strict quality systems to ensure it meets the rigorous standards required for pharmaceutical applications. Production adheres to current Good Manufacturing Practices (cGMP) and is supported by a comprehensive quality control protocol. Certificates of Analysis (COA) are provided with each batch, detailing key parameters such as assay, chloride content, particle size distribution, and residual solvents. Specifications are designed to align with major pharmacopoeial standards, including USP and EP monographs where applicable.

Storage

Preserve in a tightly closed container, protected from light. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a cool, dry place at controlled room temperature (15-25°C). Ensure the storage area is well-ventilated and separate from strong oxidizing agents.

Specification

Item	Specification
Appearance	White to off-white powder or granules
Identification (IR)	Conforms to structure
Assay (on dried basis)	Contact for details
Loss on Drying	≤ 10.0%
Residue on Ignition	≤ 1.0%
Chloride Content	Contact for details
Particle Size Distribution	Contact for details
Heavy Metals	≤ 20 ppm
Residual Solvents	Complies with ICH Q3C
Microbial Enumeration	Complies with USP <61>

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