Description

Febuxostat Descyano Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of febuxostat, a medication for the treatment of hyperuricemia in patients with gout. This impurity is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate analytical method development and validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, process optimization, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of the descyano impurity in febuxostat active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Used to develop, validate, and calibrate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Essential for routine batch testing in pharmaceutical QC labs to ensure impurity levels remain within ICH (International Council for Harmonisation) specified limits.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to monitor the formation of this specific degradation product during forced degradation and long-term stability studies of febuxostat.
• Process Chemistry Research: Aids chemists in understanding and optimizing the febuxostat synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Febuxostat Descyano Impurity
CAS No.	1206550-99-3
Molecular Formula	C16H16N2O3S
Molecular Weight	316.38 g/mol
Synonyms	Febuxostat Impurity D; Febuxostat Des-Cyano Impurity; 2-[3-Cyano-4-(2-methylpropoxy)phenyl]-4-methylthiazole-5-carboxylic Acid Descyano Analog; 2-[3-Carboxy-4-(2-methylpropoxy)phenyl]-4-methylthiazole-5-carboxylic Acid; Febuxostat Related Compound D; Febuxostat EP Impurity D; Febuxostat USP Impurity D; TMX-67 Descyano Impurity
EINECS	Contact for details

Quality Control

Our Febuxostat Descyano Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, typically assessed by HPLC, NMR, and mass spectrometry. We support compliance with ICH Q3A/B, USP, and EP guidelines, and specifications can be aligned with client-specific pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material is light-sensitive (store away from light).

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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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