Description

Topiroxostat Impurity 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 primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development and quality control. The material is supplied with comprehensive analytical data to support method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Topiroxostat API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity levels during manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and system precision standard in routine quality control testing to ensure batch-to-batch consistency.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurity profiles in drug master files (DMFs).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to determine drug shelf-life.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to develop purer synthetic routes for the API.

Basic Information

Product Name	Topiroxostat Impurity
CAS No.	2044702-36-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Topiroxostat Related Compound; Topiroxostat Degradant; Topiroxostat Process Impurity; 2-(3-Cyano-4-isobutoxyphenyl)-4-methyl-1,3-thiazole-5-carboxylic acid impurity; Febuxostat analog impurity; UR-1102 impurity; (Contact for IUPAC name and additional synonyms)
EINECS	Contact for details

Quality Control

Our Topiroxostat Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles for pharmaceutical impurities and reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w

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