Description

Topiroxostat Impurity 5 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) 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 method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quantitative and qualitative analysis of Topiroxostat API.
• Method Development and Validation: Essential for developing and validating stability-indicating HPLC or UPLC methods to monitor impurity levels.
• Quality Control (QC) Testing: Used in routine QC laboratories to confirm the identity and control the limit of this specific impurity in drug substance batches.
• Stability Studies: Employed to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research and Development: Utilized in pharmaceutical R&D to understand the degradation pathways and impurity profile of Topiroxostat during formulation development.

Basic Information

Product Name	Topiroxostat Impurity 5
CAS No.	2050015-91-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Topiroxostat Related Compound 5; Topiroxostat EP Impurity 5; Topiroxostat USP Impurity 5; 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

Every batch of Topiroxostat Impurity 5 is manufactured and handled under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 dry conditions to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
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.