Description

Topiroxostat Impurity 5 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Topiroxostat, a xanthine oxidase inhibitor. It is primarily utilized by analytical chemists and quality control professionals in the pharmaceutical and biotechnology industries. The impurity standard is essential for method development, validation, and routine batch analysis to meet stringent regulatory requirements.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Topiroxostat API and finished drug products.
• Analytical Method Development: Used to develop and validate stability-indicating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance: Employed as a system suitability and identification marker in the routine QC testing of Topiroxostat batches to ensure compliance with ICH guidelines.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to monitor impurity formation pathways.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used to identify and quantify this specific impurity during API synthesis optimization and scale-up.

Basic Information

Product Name	Topiroxostat Impurity 5
CAS No.	1199273-82-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Topiroxostat Related Compound 5; Topiroxostat EP Impurity 5; Topiroxostat USP Impurity 5; 2-[3-Cyano-4-(2-methylpropoxy)phenyl]-4-methyl-1,3-thiazole-5-carboxylic acid impurity; Febuxostat Impurity (structural analog reference); UR-1102 Impurity; FYX-051 Related Substance
EINECS	Contact for details

Quality Control

Every batch of Topiroxostat Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity, related substances, residual solvents, and other relevant analytical tests.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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