Description

Colesavelam Hydroxyquat Impurity is a high-purity chemical 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. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and routine quality control testing of drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Colesevelam HCl API and drug products.
• Analytical Method Development: Used in developing and optimizing chromatographic methods (HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance: Essential for routine batch release testing to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress and shelf-life conditions.
• Research & Development: Used in pharmaceutical R&D to understand degradation pathways and improve synthesis processes.

Basic Information

Product Name	Colesavelam Hydroxyquat Impurity
CAS No.	676578-21-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Colesevelam Hydroxyquat Impurity; Colesevelam Related Compound; 676578-21-5; Hydroxyquat Impurity of Colesevelam; Colesevelam Impurity; Colesevelam HCl Impurity; Colesevelam Process Impurity; Pharmaceutical Impurity Standard
EINECS	Contact for details

Quality Control

Our Colesavelam Hydroxyquat Impurity is manufactured and handled under strict quality systems. Each batch is subjected to comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR) and purity assessment by chromatographic techniques (HPLC). We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, impurities, and other critical parameters to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
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.