Description

Febuxostat Impurity 130 is a designated reference standard used in the pharmaceutical development 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 analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Febuxostat API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing to ensure Febuxostat meets pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Employed to track the formation of this specific impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development (R&D): Used in synthetic route optimization and degradation studies to understand and control impurity formation pathways.

Basic Information

Product Name	Febuxostat Impurity 130
CAS No.	1643131-93-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Febuxostat Related Compound 130; Febuxostat Impurity; Febuxostat Process Impurity; Febuxostat Degradant; Febuxostat Related Substance 130; Febuxostat Specified Impurity; 2-[3-Cyano-4-(2-methylpropoxy)phenyl]-4-methylthiazole-5-carboxylic acid impurity; Uloric Impurity
EINECS	Contact for details

Quality Control

Our Febuxostat Impurity 130 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and confirmatory identification (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert conditions to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unidentified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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