Description

Febuxostat Butyl Ester Impurity is a high-purity chemical reference standard used in the pharmaceutical development and quality control of febuxostat, a medication for chronic gout. This specific impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of process-related impurities in Febuxostat API.
• Analytical Method Development and Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Serves as a benchmark in routine batch release testing to ensure API purity meets pharmacopeial standards (e.g., USP, ICH Q3A/B).
• Stability Studies: Employed to track the formation and growth of this specific degradant under various stress conditions (forced degradation studies).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to understand and optimize the febuxostat manufacturing process to minimize impurity formation.

Basic Information

Product Name	Febuxostat Butyl Ester Impurity
CAS No.	1619982-02-3
Molecular Formula	C20H22N2O3S
Molecular Weight	370.47 g/mol
Synonyms	Febuxostat Butyl Ester; 2-[3-Cyano-4-(2-methylpropoxy)phenyl]-4-methyl-1,3-thiazole-5-carboxylic Acid Butyl Ester; Febuxostat Butyl Ester Related Compound; Uloric Butyl Ester Impurity; TEI-6720 Butyl Ester; TMX-67 Butyl Ester Impurity
EINECS	Contact for details

Quality Control

Our Febuxostat Butyl Ester Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with industry standards. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your GMP and ICH regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (by HPLC)	≥ 98.0%
Related Substances (by HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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