Description

Topiroxostat Impurity 4 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Topiroxostat. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams involved in the development and manufacturing of xanthine oxidase inhibitors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Topiroxostat Impurity 4 in API and finished drug products.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-High-Performance Liquid Chromatography (UPLC) methods.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of Topiroxostat formulations.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization and control data.
• Quality Control Testing: Employed in routine batch release testing to ensure impurity levels remain within International Council for Harmonisation (ICH) specified limits.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Topiroxostat to minimize the formation of this impurity.

Basic Information

Product Name	Topiroxostat Impurity 4
CAS No.	1379342-46-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Topiroxostat Related Compound 4; Febuxostat Impurity 4 (related); 2-(3-Cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylic acid impurity; UNII-7V8A4U6785; Topiroxostat EP Impurity C; Topiroxostat USP Impurity; Potential degradation product of Topiroxostat
EINECS	Contact for details

Quality Control

Our Topiroxostat Impurity 4 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests such as HPLC purity, NMR, and mass spectrometry for structural confirmation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material under appropriate laboratory conditions to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0% (Area Percent)
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.