Description

Colesevelam 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 HCl, a bile acid sequestrant. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The material is supplied with comprehensive analytical data to support rigorous quality control protocols.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the Hydroxyquat impurity in Colesevelam HCl drug substance and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in compliance with ICH Q2(R1) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Serves as a system suitability standard and for setting specification limits in the routine QC testing of pharmaceutical raw materials and products.
• Stability Studies: Employed to monitor impurity levels in forced degradation and long-term stability studies of Colesevelam-based formulations.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Colesevelam.

Basic Information

Product Name	Colesevelam Hydroxyquat Impurity
CAS No.	359436-99-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-Butanaminium, N,N,N-triethyl-, salt with 1-deoxy-1-[[6-[4-[[4-[[(4-ethenylphenyl)methyl]amino]butyl]amino]-4-oxobutanoyl]amino]hexyl]amino]-D-glucitol (1:?) Colesevelam Related Compound Hydroxyquat Impurity of Colesevelam Colesevelam Process Impurity Colesevelam Degradant WelChol Impurity
EINECS	Contact for details

Quality Control

Our Colesevelam Hydroxyquat Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with major pharmacopoeial standards (USP, EP) for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

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: ≤ 0.5% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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