Description

Topiroxostat Impurity 2 is a designated impurity standard of the active pharmaceutical ingredient Topiroxostat, a xanthine oxidase inhibitor. This high-purity reference material is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily used by research institutions, quality control laboratories, and pharmaceutical companies involved in the development and production of Topiroxostat-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Topiroxostat Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to ensure specificity, accuracy, and precision in impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure drug substance and product compliance with stringent pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data on impurity identity and qualification for inclusion in regulatory filings (e.g., ANDA, NDA) to health authorities like the FDA and EMA.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during API synthesis, enabling process optimization and impurity control strategies.

Basic Information

Product Name	Topiroxostat Impurity 2
CAS No.	445218-61-1
Molecular Formula	C13H11N5O2S
Molecular Weight	301.33 g/mol
Synonyms	2-(3-Cyano-4-isobutoxyphenyl)-4-methyl-1,3-thiazole-5-carboxylic acid; Topiroxostat Related Compound B; 4-Methyl-2-[3-cyano-4-(2-methylpropoxy)phenyl]-1,3-thiazole-5-carboxylic acid; UNII-4Z8K7CL3VK; Topiroxostat Impurity B; 4-Methyl-2-[3-cyano-4-(isobutoxy)phenyl]thiazole-5-carboxylic acid; FX-115
EINECS	Contact for details

Quality Control

Our Topiroxostat Impurity 2 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from multiple orthogonal techniques, including HPLC for purity, NMR and MS for structural confirmation, and KF for water content. The material is suitable for use as a pharmaceutical reference standard in compliance with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This compound is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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