Description

Febuxostat Impurity 21 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Febuxostat. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key reference standard for the identification, quantification, and control of this specific impurity during the development and production of Febuxostat, a medication used to treat hyperuricemia in patients with gout.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Febuxostat API.
• Method Development and Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Febuxostat.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) as part of forced degradation studies.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports process chemistry research to understand and minimize impurity formation during API synthesis.

Basic Information

Item	Detail
Product Name	Febuxostat Impurity 21
CAS No.	1346238-12-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Febuxostat Related Compound 21; 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 21 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis to meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results, and is available upon request to support your regulatory and quality needs.

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 place. For long-term storage, consider storing under inert conditions.

Specification

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

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