Description

Topiroxostat Impurity 15 is a designated impurity reference standard used in the analytical profiling 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 for quality control, method development, and validation processes.

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, optimizing, and validating stability-indicating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure compliance with ICH Q3A/B guidelines and pharmacopeial monographs.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports synthetic route optimization and degradation pathway studies during drug development.

Basic Information

Product Name	Topiroxostat Impurity 15
CAS No.	87544-86-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Topiroxostat Related Compound 15; Topiroxostat EP Impurity 15; Topiroxostat USP Impurity 15; 2-(3-Cyano-4-isobutoxyphenyl)-4-methyl-1,3-thiazole-5-carboxylic acid impurity; Febuxostat Impurity (structural analog); UR-1102 Impurity; TMX-049 Impurity
EINECS	Contact for details

Quality Control

Every batch of Topiroxostat Impurity 15 is manufactured and analyzed under strict quality management systems. The product is characterized and qualified using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure high purity and correct structural identity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality standards align with ICH guidelines and support compliance requirements for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

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%
Assay	≥ 98.0% (on dried basis)
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.