Description

Febuxostat Impurity 36 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Febuxostat. This compound is critical for ensuring the purity, safety, and efficacy of Febuxostat formulations by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Febuxostat Impurity 36 in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods for Febuxostat.
• Quality Control & Batch Release: Employed in routine quality control laboratories to monitor impurity levels against established specifications to ensure compliance with ICH guidelines.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization and control data.
• Research & Development: Facilitates process chemistry research aimed at understanding and minimizing impurity formation during Febuxostat synthesis.

Basic Information

Item	Details
Product Name	Febuxostat Impurity 36
CAS No.	1805770-40-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Febuxostat Related Compound 36; Febuxostat Impurity F; Febuxostat EP Impurity G; Febuxostat Process Impurity; 2-[3-Cyano-4-(2-methylpropoxy)phenyl]-4-methylthiazole-5-carboxylic acid impurity; Uloric Impurity 36; TEI-6720 Impurity 36
EINECS	Contact for details

Quality Control

Our Febuxostat Impurity 36 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by HPLC to ensure it meets the stringent requirements for a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with every shipment, containing batch-specific data on purity, impurities, and chromatographic profile.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.