Description

Febuxostat Impurity 32 Hcl is a high-purity chemical reference standard, specifically identified as a hydrochloride salt impurity of the active pharmaceutical ingredient Febuxostat. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of process-related impurities. It is primarily utilized by analytical chemists, quality assurance professionals, and R&D scientists within the pharmaceutical and biotechnology sectors to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying Febuxostat-related impurities during method development and validation.
• Analytical Method Development: Used as a critical standard in HPLC, UPLC, and LC-MS analyses to establish specificity, accuracy, and detection limits for impurity assays.
• Quality Control and Batch Release Testing: Essential for routine quality control testing of Febuxostat API batches to ensure they meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to monitor the formation of degradation impurities in Febuxostat drug substances and products under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes by tracking the formation and clearance of this specific impurity.

Basic Information

Product Name	Febuxostat Impurity 32 Hcl
CAS No.	1267681-15-1
Molecular Formula	C16H17ClN2O3S
Molecular Weight	352.84 g/mol
Synonyms	Febuxostat Related Compound 32 Hydrochloride; 2-[(3-Cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylic acid] Hydrochloride Impurity; Febuxostat HCl Impurity 32; Febuxostat EP Impurity H HCl; Febuxostat USP Impurity 32 Hydrochloride; 2-[3-Cyano-4-(2-methylpropoxy)phenyl]-4-methyl-5-thiazolecarboxylic acid hydrochloride; TEI-6720 Impurity 32 HCl
EINECS	Contact for details

Quality Control

Every batch of Febuxostat Impurity 32 Hcl is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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