Description

Febuxostat Bromo Impurity is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Febuxostat. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and manufacturers involved in the production and regulatory compliance of Febuxostat-based medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Febuxostat API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, optimizing, and validating stability-indicating assay methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Used in routine QC testing to ensure Febuxostat batches comply with stringent pharmacopeial limits (e.g., ICH Q3A/B) for unspecified impurities.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (forced degradation studies).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Febuxostat to minimize the formation of this bromo impurity.

Basic Information

Product Name	Febuxostat Bromo Impurity
CAS No.	144060-40-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	2-[3-Cyano-4-(2-methylpropoxy)phenyl]-4-methyl-5-thiazolecarboxylic acid bromo impurity; Febuxostat Brominated Impurity; Febuxostat Related Compound B (potential designation); Febuxostat Bromo Analog; Uloric Bromo Impurity; TEI-6720 Bromo Impurity; TMX-67 Bromo Impurity
EINECS	Contact for details

Quality Control

Our Febuxostat Bromo Impurity is manufactured under strict quality management systems. Each batch is subjected to rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. We provide comprehensive Certificates of Analysis (COA) that detail purity, impurity profiles, and analytical methods, supporting compliance with ICH guidelines and regulatory requirements for pharmaceutical impurities.

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 prevent degradation upon exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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