Description

Colesevelam Methoxyquat Impurity is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient, Colesevelam HCl. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of process-related impurities in Colesevelam HCl API.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels during drug substance synthesis.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in QC laboratories to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, humidity, light).
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the fate of related substances.

Basic Information

Product Name	Colesevelam Methoxyquat Impurity
CAS No.	863031-14-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Methoxyquat Impurity of Colesevelam; Colesevelam Related Compound; 1-Decanaminium, N,N,N-trimethyl-10-(4-methylphenyl)-, chloride (1:1), (10-(4-methylphenyl)decyl)trimethylammonium chloride (related to Colesevelam); Colesevelam Process Impurity; Colesevelam Hydrochloride Impurity; 863031-14-5; Colesevelam Methoxyquat Related Substance
EINECS	Contact for details

Quality Control

Our Colesevelam Methoxyquat Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.