Description

Febuxostat Impurity 37 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Febuxostat. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Febuxostat API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (e.g., heat, light, humidity) as per ICH stability protocols.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings to health authorities like the FDA and EMA.
• Research & Development: Used in R&D laboratories for studying the degradation pathways and impurity profile of Febuxostat.

Basic Information

Item	Detail
Product Name	Febuxostat Impurity 37
CAS No.	1229019-33-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Febuxostat Related Compound 37; Febuxostat Impurity K; Febuxostat EP Impurity K; 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

Our Febuxostat Impurity 37 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines.

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 dry conditions to maintain stability and purity.

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 unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
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.