Description

Lesinurad Impurity 2 CAS NO 1158970-37-6 is a high-purity chemical reference standard specifically identified as a process-related impurity of Lesinurad, a medication used for the treatment of hyperuricemia associated with gout. This impurity is critical for pharmaceutical research and development, enabling rigorous analytical method development, stability studies, and quality control to ensure the safety and efficacy of the final drug product. It is an essential material for analytical chemists, quality assurance laboratories, and regulatory affairs professionals within the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of this specific impurity in Lesinurad Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection in compliance with ICH guidelines.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this impurity under various stress conditions (e.g., heat, light, humidity).
• Quality Control and Batch Release Testing: Acts as a system suitability standard and a quantitative calibrant in the routine QC testing of Lesinurad API to ensure it meets stringent purity specifications.
• Regulatory Submission and Compliance: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds, justify specifications, and demonstrate comprehensive control of the manufacturing process.
• Research on Degradation Pathways: Aids in studying the chemical degradation mechanisms of Lesinurad, helping to improve formulation strategies and shelf-life predictions.

Basic Information

Item	Details
Product Name	Lesinurad Impurity 2
CAS No.	1158970-37-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	2-(5-Bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)acetic acid; Lesinurad Related Compound 2; Lesinurad Process Impurity; Lesinurad Analog; Lesinurad Bromo Impurity; 1-[4-Cyclopropyl-5-(5-bromo-4H-1,2,4-triazol-3-ylsulfanyl)thiophen-2-yl]-2,2,2-trifluoroethanone (Isomer); ZUR-003 Impurity
EINECS	Contact for details

Quality Control

Every batch of Lesinurad Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency in line with current industry and regulatory expectations for reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and impurity profile.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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