Description

Febuxostat Impurity 33 is a designated impurity of the active pharmaceutical ingredient Febuxostat, a xanthine oxidase inhibitor used in the treatment of hyperuricemia and gout. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Febuxostat drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Febuxostat API and formulations.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance: Used in routine QC testing to ensure Febuxostat batches meet stringent pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Item	Detail
Product Name	Febuxostat Impurity 33
CAS No.	100118-38-5
Molecular Formula	C16H16N2O3S
Molecular Weight	316.38 g/mol
Synonyms	Febuxostat Related Compound 33; 2-[(3-Cyano-4-isobutoxyphenyl)carbamoyl]-5-methylthiophene-3-carboxylic Acid; 5-Methyl-2-({[3-cyano-4-(2-methylpropoxy)phenyl]carbamoyl})thiophene-3-carboxylic Acid; Febuxostat Impurity F; Febuxostat EP Impurity G; Febuxostat USP Impurity; TEI-6720 Impurity
EINECS	Contact for details

Quality Control

Every batch of Febuxostat Impurity 33 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all test results against predefined specifications. Our quality standards align with ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.

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 must be kept under inert conditions or in a desiccator to maintain stability and purity. Avoid prolonged exposure to high humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
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.