Description

Febuxostat Impurity 7 is a designated impurity standard of the active pharmaceutical ingredient Febuxostat, a xanthine oxidase inhibitor used in the treatment of hyperuricemia and gout. This high-purity reference material is critical for pharmaceutical research, development, and quality control, ensuring the safety and efficacy of the final drug product by enabling accurate identification and quantification of process-related impurities. It is an essential tool for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly for method validation, stability studies, and regulatory compliance submissions.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Febuxostat Impurity 7 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development and Validation (HPLC/LC-MS): Critical for developing, optimizing, and validating chromatographic methods to separate and detect impurities in Febuxostat batches.
• Quality Control and Batch Release Testing: Used in routine QC laboratories to monitor impurity profiles and ensure Febuxostat API meets stringent pharmacopeial (e.g., USP, EP) or internal specification limits.
• Stability Studies and Forced Degradation Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Documentation and Submission: Supports the preparation of regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurity profiles.
• Research and Process Chemistry: Aids in understanding the synthesis pathway of Febuxostat and in optimizing manufacturing processes to minimize the formation of this impurity.

Basic Information

Product Name	Febuxostat Impurity 7
CAS No.	1350352-70-3
Molecular Formula	C16H16N2O3S
Molecular Weight	316.38 g/mol
Synonyms	2-[(3-Cyano-4-isobutoxyphenyl)carbamoyl]thiophene-3-carboxylic acid; Febuxostat Impurity G (EP); Febuxostat Related Compound G; Febuxostat Carboxylic Acid Impurity; Thiophene-3-carboxylic acid, 2-[[(3-cyano-4-isobutoxyphenyl)amino]carbonyl]-; Febuxostat Acid Impurity; Febuxostat Process Impurity
EINECS	Contact for details

Quality Control

Our Febuxostat Impurity 7 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques including HPLC, LC-MS, NMR, and IR to confirm identity and ensure high purity. We provide full traceability and detailed Certificates of Analysis (COA) with each shipment, which include batch-specific data on purity, impurities, and chromatographic profiles. The material is suitable for use as a reference standard in compliance with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The material is stable under these conditions; prolonged exposure to moisture, heat, or light should be avoided.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
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.