Description

Colesevelam Impurity 3 is a specified impurity of the active pharmaceutical ingredient Colesevelam HCl, a bile acid sequestrant used to treat hypercholesterolemia. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control to ensure drug safety and efficacy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, purification, and rigorous testing of Colesevelam HCl to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Colesevelam HCl drug substance and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during the drug manufacturing process.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines on impurities.
• Stability Studies: Used to track the formation of degradation products in stability testing of Colesevelam HCl under various ICH-prescribed conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Colesevelam Impurity 3
CAS No.	2170771-70-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Colesevelam Related Compound 3; Colesevelam HCl Impurity 3; Colesevelam EP Impurity C; Colesevelam USP Impurity; 1-Decanaminium, N-(2-aminoethyl)-N-methyl-, chloride, polymer with (chloromethyl)oxirane and 1,6-hexanediamine, hydrochloride; Poly(allylamine-co-N,N-diallyl-1,3-diaminopropane) crosslinked epichlorohydrin impurity; Colesevelam polymer impurity
EINECS	Contact for details

Quality Control

Every batch of Colesevelam Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each 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 kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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