Description

Febuxostat Impurity 46 is a high-purity chemical reference standard used in the development and quality control of the active pharmaceutical ingredient Febuxostat. This compound is critical for ensuring the safety and efficacy of Febuxostat drug products by enabling accurate identification and quantification of this specific impurity during analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and contract research organizations (CROs) focused on analytical method development and validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Febuxostat.
• Analytical Method Development: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance: Serves as a system suitability standard and for routine batch testing in pharmaceutical manufacturing to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Filing: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to establish impurity thresholds and control strategies.
• Stability Studies: Employed to track the formation and level of this impurity in Febuxostat drug substances and products under various storage conditions.
• Research & Development: Used in studies to understand the degradation pathways and synthesis-related impurities of Febuxostat.

Basic Information

Item	Details
Product Name	Febuxostat Impurity 46
CAS No.	2113749-11-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Febuxostat Related Compound 46; Febuxostat Impurity F; Febuxostat EP Impurity G; Febuxostat USP Impurity; 2-[3-Cyano-4-(2-methylpropoxy)phenyl]-4-methylthiazole-5-carboxylic acid impurity; Uloric Impurity; TEI-6720 Impurity
EINECS	Contact for details

Quality Control

Every batch of Febuxostat Impurity 46 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (e.g., HPLC, NMR, MS) to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all analytical results.

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 (moisture-sensitive) nature, the container should be kept in a desiccated environment to maintain stability and purity.

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%
Residual Solvents (GC)	Complies with ICH Q3C
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.