Description

Topiroxostat Impurity 6 CAS NO 2044704-63-2 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 Topiroxostat. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Topiroxostat API.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods for impurity identification and quantification.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the impurity's profile and behavior.
• Calibration & System Suitability: Serves as a calibrant to ensure the accuracy and precision of analytical instrumentation.

Basic Information

Product Name	Topiroxostat Impurity 6
CAS No.	2044704-63-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Topiroxostat Related Compound 6; Topiroxostat EP Impurity 6; Topiroxostat USP Impurity 6; Febuxostat Impurity (structural analog); 2-[3-Cyano-4-(2-methylpropoxy)phenyl]-4-methylthiazole-5-carboxylic acid impurity; UR-1102 Impurity; FYX-051 Impurity
EINECS	Contact for details

Quality Control

Our Topiroxostat Impurity 6 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to a primary reference standard.

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 inert atmosphere or in a desiccator to maintain stability and purity.

Specification

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

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