Description

Febuxostat Impurity 41 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Febuxostat, a medication for chronic gout. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by providing a benchmark for identification and quantification. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and batch release testing.

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 (HPLC/LC-MS): Essential for developing and validating sensitive analytical methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Indicating Studies: Used to assess the degradation pathways and shelf-life of Febuxostat formulations under various stress conditions.
• Quality Control and Batch Release: A critical tool for in-house QC laboratories to ensure that Febuxostat batches meet stringent purity specifications before commercial release.
• Regulatory Submissions: Provides necessary data on impurity identification and characterization for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports synthetic route optimization and impurity fate and tolerance studies during the drug development process.

Basic Information

Product Name	Febuxostat Impurity 41
CAS No.	2428631-67-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Febuxostat Related Compound 41; Febuxostat Impurity RRT 0.41; Febuxostat Process Impurity; Febuxostat Degradant; 2-[3-Cyano-4-(2-methylpropoxy)phenyl]-4-methylthiazole-5-carboxylic acid impurity; Uloric Impurity 41; TEI-6720 Impurity 41
EINECS	Contact for details

Quality Control

Every batch of Febuxostat Impurity 41 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA), detailing identity, purity, and impurity profile, is provided with each shipment to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area.

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)	Individual unknown 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.