Description

Febuxostat Impurity 16 CAS NO 2473435-22-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Febuxostat, a medication used to treat hyperuricemia in patients with gout. It serves as an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, stability studies, and regulatory compliance testing. The availability of this well-characterized impurity is vital for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Febuxostat API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in-house by API manufacturers to set internal specifications and ensure batch-to-batch consistency.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing data on impurity characterization and control strategies.
• Stability Studies: Employed to track the formation of degradation products in Febuxostat under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in pharmaceutical R&D to study the metabolic pathways, degradation mechanisms, and synthesis pathways of Febuxostat.

Basic Information

Product Name	Febuxostat Impurity 16
CAS No.	2473435-22-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Febuxostat Related Compound 16; Febuxostat Impurity; Febuxostat Process Impurity; Febuxostat Degradant; Uloric Impurity 16; TEI-6720 Impurity 16; 2-[(3-Cyano-4-isobutoxyphenyl)methyl]-4-methylthiazole-5-carboxylic acid impurity; Febuxostat Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Febuxostat Impurity 16 is produced and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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 (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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