Description

Febuxostat Impurity 8 is a designated impurity standard used in the pharmaceutical development and quality control of Febuxostat, a xanthine oxidase inhibitor. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Febuxostat Impurity 8 in Febuxostat API and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to monitor and control impurity levels, ensuring product meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• 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 impurity formation pathways and to develop purification processes.

Basic Information

Item	Detail
Product Name	Febuxostat Impurity 8
CAS No.	144060-62-8
Molecular Formula	C16H16N2O3S
Molecular Weight	316.38 g/mol
Synonyms	2-[(3-Cyano-4-isobutoxyphenyl)amino]-4-methylthiazole-5-carboxylic acid; Febuxostat Impurity F; Febuxostat Related Compound 8; Febuxostat EP Impurity F; Febuxostat USP Impurity F; Uloric Impurity; TEI-6720 Impurity
EINECS	Contact for details

Quality Control

Every batch of Febuxostat Impurity 8 is manufactured and tested under strict quality management systems. We provide comprehensive analytical data, including HPLC purity, identity confirmation (IR, NMR, MS), and residual solvent analysis, to ensure compliance with pharmacopeial standards. A Certificate of Analysis (COA) with batch-specific results is supplied with each shipment.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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