Description

Febuxostat Impurity 70 is a designated reference standard used in the pharmaceutical development and quality control of Febuxostat, a xanthine oxidase inhibitor. This high-purity compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, pharmaceutical manufacturers, and research institutions involved in method validation, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Febuxostat API and finished dosage forms.
• Method Development and Validation: Essential for developing and validating robust analytical methods, particularly HPLC and UPLC, for impurity detection and quantification.
• Stability Indicating Studies: Used to monitor the formation of this specific impurity during forced degradation and long-term stability studies of Febuxostat.
• Quality Control & Assurance: A critical tool in QC laboratories to establish impurity limits and ensure batch-to-batch consistency in compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to define impurity profiles and justify specification limits.
• Research and Development: Supports synthetic route optimization and impurity fate and tolerance studies during the drug development process.

Basic Information

Product Name	Febuxostat Impurity 70
CAS No.	2418591-43-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Febuxostat Related Compound 70; Febuxostat Impurity F; Febuxostat EP Impurity G; Febuxostat USP Impurity; 2-[3-Cyano-4-(2-methylpropoxy)phenyl]-4-methylthiazole-5-carboxylic acid impurity; Febuxostat Process Impurity; Febuxostat Degradant
EINECS	Contact for details

Quality Control

Every batch of Febuxostat Impurity 70 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (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 each shipment to support your regulatory and quality requirements.

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 desiccated at 2-8°C.

Specification

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