Description

Colestilan is a non-absorbed, polymeric anion exchange resin used primarily as a pharmaceutical active ingredient. This compound is significant for its ability to bind bile acids in the gastrointestinal tract, thereby reducing serum cholesterol levels. It is a critical raw material for manufacturers in the global pharmaceutical industry developing treatments for hypercholesterolemia and related cardiovascular conditions.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the key component in oral medications for lowering high cholesterol (hypercholesterolemia).
• Bile Acid Sequestrant: Functions to bind bile acids in the intestine, interrupting the enterohepatic circulation and promoting cholesterol excretion.
• Cardiovascular Disease Management: Formulated into tablets or sachets for preventative and therapeutic regimens against atherosclerosis and coronary heart disease.
• Research & Development: Used in preclinical and clinical studies for investigating new lipid-lowering therapies and combination treatments.
• GMP Manufacturing: Supplied as a high-purity bulk chemical for compliant production under Good Manufacturing Practice (GMP) standards.

Basic Information

Product Name	Colestilan
CAS No.	95522-45-5
Molecular Formula	(C9H11Cl2N)n
Molecular Weight	Polymeric substance
Synonyms	Colestilan; BXT-51072; Cholebine; 2-Methylimidazolium, 1-ethenyl-, chloride, polymer with 1,2-dichloroethane; Poly(2-methyl-1-vinylimidazolium chloride-co-1,2-dichloroethane); 1-Ethenyl-2-methyl-1H-imidazol-3-ium chloride polymer with 1,2-dichloroethane; MCI-196
EINECS	Contact for details

Quality Control

Our Colestilan is manufactured and tested to meet stringent pharmaceutical-grade specifications. Quality assurance protocols align with ICH guidelines and current Good Manufacturing Practice (cGMP) principles for active pharmaceutical ingredients (APIs). A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing purity, identity, and impurity profiles to ensure supply reliability and regulatory compliance 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 after opening to prevent moisture absorption, which can affect stability and handling properties.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Assay (on dried basis)	NLT 98.0%
Loss on Drying	NMT 5.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 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.