Description

Topiroxostat Impurity E CAS NO 2227142-15-4 is a high-purity reference standard specifically identified as a process-related impurity of Topiroxostat, a xanthine oxidase inhibitor used in the treatment of hyperuricemia and gout. This impurity is critical for pharmaceutical research and development, enabling accurate method validation, stability studies, and ensuring the safety and efficacy of the final drug product. It is primarily utilized by analytical laboratories, quality control departments, and regulatory affairs teams within the pharmaceutical and biotechnology industries to meet stringent regulatory requirements for drug substance characterization.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Topiroxostat active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor and control impurity profiles in compliance with ICH guidelines.
• Stability Indicating Studies: Used to assess the degradation pathways and shelf-life of Topiroxostat formulations under various stress conditions (e.g., heat, light, humidity).
• Quality Control and Batch Release: A critical tool for in-house QC testing to ensure batch-to-batch consistency and that impurity levels remain within specified safety thresholds.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to agencies like the FDA and EMA.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Topiroxostat to minimize the formation of this specific impurity.

Basic Information

Product Name	Topiroxostat Impurity E
CAS No.	2227142-15-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Topiroxostat Related Compound E; Topiroxostat EP Impurity E; Topiroxostat USP Impurity E; (2-[(3,5-Dicyano-4-isobutylpyridin-2-yl)thio]-6-methylpyrimidin-4-yl)carbamic acid tert-butyl ester; FC-4211 Impurity E; UR-1102 Impurity E; 2-[(3,5-Dicyano-4-isobutyl-2-pyridinyl)thio]-N-(1,1-dimethylethoxy)-6-methyl-4-pyrimidinecarboxamide
EINECS	Contact for details

Quality Control

Our Topiroxostat Impurity E is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assessment and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for identity, purity, and assay. Our quality commitment aligns with the needs of cGMP-compliant laboratories and supports regulatory filings.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.