Description

Febuxostat Impurity 32 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 Febuxostat, a medication used to treat hyperuricemia in patients with gout. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Impurity Profiling and Identification in Febuxostat API and finished dosage forms.
• Analytical Method Development and Validation for HPLC, UPLC, and LC-MS techniques.
• Stability Studies and Forced Degradation Studies to monitor impurity formation over time.
• Quality Control and Release Testing of Febuxostat batches against pharmacopeial standards (USP, EP).
• Reference Standard for Regulatory Submissions to agencies like the FDA and EMA.
• Research and Development into the metabolism and degradation pathways of Febuxostat.
• Calibration of Analytical Equipment for accurate quantification of specific impurities.

Basic Information

Product Name	Febuxostat Impurity 32
CAS No.	1805770-41-5
Molecular Formula	C16H16N2O3S
Molecular Weight	316.38 g/mol
Synonyms	Febuxostat Related Compound 32; Febuxostat EP Impurity I; Febuxostat USP Impurity; 2-[(3-Cyano-4-isobutoxyphenyl)methyl]-4-methylthiazole-5-carboxylic acid impurity; Febuxostat Degradation Product; Uloric Impurity; TEI-6720 Impurity; Febuxostat Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Febuxostat Impurity 32 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications. Our quality commitment ensures the material is suitable for its intended use in pharmaceutical analysis and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 0.5%
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.