Description

Topiroxostat Impurity 9 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Topiroxostat. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of xanthine oxidase inhibitors.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Topiroxostat API.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for compliance with ICH guidelines.
• Essential for stability studies and degradation pathway elucidation of Topiroxostat formulations.
• Used in quality control (QC) and quality assurance (QA) laboratories to establish impurity profiles and release specifications.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data.
• Valuable for research and development of synthetic routes and purification processes for Topiroxostat.

Basic Information

Product Name	Topiroxostat Impurity 9
CAS No.	2044708-04-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Topiroxostat Related Compound 9; Topiroxostat Impurity C; 2-(3-Cyano-4-isobutoxyphenyl)-4-methyl-1,3-thiazole-5-carboxylic acid impurity; UR-1102 Impurity 9; Febuxostat analog impurity; Xanthine Oxidase Inhibitor Impurity; Topiroxostat Process Impurity
EINECS	Contact for details

Quality Control

Our Topiroxostat Impurity 9 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is fully characterized and undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; ensure the container is sealed under inert atmosphere if necessary and opened only in a dry environment.

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%
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.