Description

Febuxostat Impurity J is a designated impurity of the active pharmaceutical ingredient Febuxostat, a xanthine oxidase inhibitor used in the treatment of hyperuricemia and gout. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Febuxostat drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Febuxostat API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance: Critical for routine batch testing in pharmaceutical manufacturing to monitor and control impurity levels per ICH Q3A/B guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of degradation impurities in Febuxostat under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Febuxostat.

Basic Information

Product Name	Febuxostat Impurity J
CAS No.	1346238-13-8
Molecular Formula	C16H16N2O3S
Molecular Weight	316.38 g/mol
Synonyms	2-[(3-Cyano-4-isobutoxyphenyl)carbamoyl]thiophene-3-carboxylic acid; Febuxostat Related Compound J; Febuxostat Impurity 10; Febuxostat EP Impurity J; Febuxostat USP Impurity J; Uloric Impurity J; TEI-6720 Impurity J
EINECS	Contact for details

Quality Control

Our Febuxostat Impurity J is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing batch-specific results and confirming its suitability for use as a reference standard.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. 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
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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