Description

Topiroxostat Impurity 19 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 (API) Topiroxostat, a xanthine oxidase inhibitor. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling. The reliable identification and quantification of this impurity are fundamental to meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control (QC) and release testing of Topiroxostat API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection and separation.
• Stability Studies & Degradation Profiling: Used to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Compliance & Documentation: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications in accordance with ICH Q3A/B guidelines.
• Research & Development: Utilized in pharmacokinetic and metabolic studies to understand the fate and potential impact of this impurity.
• Calibration & System Suitability: Acts as a calibrant to ensure the accuracy and precision of analytical instrumentation used in QC laboratories.

Basic Information

Product Name	Topiroxostat Impurity 19
CAS No.	2044706-50-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Topiroxostat Related Compound 19; Topiroxostat Impurity; Febuxostat Impurity (structural analog); 2-(3-Cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylic acid derivative; UR-1102 Impurity; Xanthine Oxidase Inhibitor Impurity; TPI-19
EINECS	Contact for details

Quality Control

Our Topiroxostat Impurity 19 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity (HPLC/UPLC), identity confirmation (IR, MS, NMR), and residual solvent analysis to ensure it meets the highest standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines.

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 COA. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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