Description

Febuxostat Impurity 61 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, a medication used to treat hyperuricemia in patients with gout. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are fundamental to meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Febuxostat.
• Impurity Profiling and Characterization: Used in HPLC, LC-MS, and GC-MS methods to identify, monitor, and control the levels of Febuxostat Impurity 61 in drug substances and products.
• Method Development and Validation: Serves as a critical component in developing and validating analytical procedures according to ICH Q2(R1) guidelines.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Quality Control (QC) Testing: Essential for in-process control and release testing of Febuxostat API batches to ensure they meet specified impurity limits.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity understanding and control strategies.
• Research and Development: Used in synthetic chemistry research to study the formation pathways and chemical properties of Febuxostat-related substances.

Basic Information

Product Name	Febuxostat Impurity 61
CAS No.	168780-80-1
Molecular Formula	C16H16N2O3S
Molecular Weight	316.38 g/mol
Synonyms	2-[(3-Cyano-4-isobutoxyphenyl)amino]-4-methylthiazole-5-carboxylic acid; Febuxostat Related Compound 61; Febuxostat Impurity F; Febuxostat Process Impurity; Uloric Impurity 61; TEI-6720 Impurity; Thiazolecarboxylic acid derivative impurity
EINECS	Contact for details

Quality Control

Our Febuxostat Impurity 61 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established specifications. The material is suitable for use as a reference standard in compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under an inert atmosphere.

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 single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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