Description

Febuxostat Impurity 6 CAS NO 1271738-74-9 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. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference standard for the identification and quantification of a specific impurity in Febuxostat drug substance and finished products.
• Analytical Method Development and Validation: Used as a critical component in developing and validating HPLC, UPLC, or other chromatographic methods for Febuxostat analysis.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Febuxostat API.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing a characterized impurity standard for stability studies and specification setting.
• Research and Development: Utilized in pharmaceutical R&D to study the degradation pathways, stability, and metabolism of Febuxostat.
• Pharmacopoeial Standards: Can be used as a working standard in conjunction with official pharmacopoeial monographs (e.g., USP, EP) for Febuxostat.

Basic Information

Product Name	Febuxostat Impurity 6
CAS No.	1271738-74-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Febuxostat Related Compound 6; Febuxostat Impurity F; Febuxostat EP Impurity F; Febuxostat USP Impurity; 2-[(3-Cyano-4-isobutoxyphenyl)methyl]-4-methylthiazole-5-carboxylic acid impurity; Febuxostat Degradation Product; Febuxostat Process Impurity
EINECS	Contact for details

Quality Control

Our Febuxostat Impurity 6 is manufactured under strict quality control protocols to ensure the highest standards of purity and identity. Each batch is thoroughly characterized using advanced analytical techniques, including HPLC, GC, MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay, and impurity profile. We support compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

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 structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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