Description

Lesinurad Impurity B CAS NO 1533519-93-5 is a specified impurity of Lesinurad, a pharmaceutical agent used in the treatment of hyperuricemia associated with gout. This impurity is a critical reference standard for analytical and quality control purposes in pharmaceutical development and manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require high-purity chemical standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Lesinurad active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Critical for preparing documentation for regulatory agencies (e.g., FDA, EMA) to demonstrate thorough impurity characterization.
• Stability Studies: Used as a marker to track impurity formation in Lesinurad drug products under various stability conditions.
• Research & Development: Facilitates studies on the degradation pathways and chemical behavior of Lesinurad.

Basic Information

Product Name	Lesinurad Impurity B
CAS No.	1533519-93-5
Molecular Formula	C17H14BrN3O3S
Molecular Weight	420.28 g/mol
Synonyms	2-(5-Bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)acetic acid; 1-Cyclopropyl-4-((5-mercapto-4-(4-(trifluoromethyl)phenyl)-4H-1,2,4-triazol-3-yl)methyl)naphthalene; Lesinurad Related Compound B; Lesinurad EP Impurity B; Lesinurad USP Impurity B; Lesinurad Process Impurity; RDEA594 Impurity B
EINECS	Contact for details

Quality Control

Every batch of Lesinurad Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards (USP, EP, ICH). 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 at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Heavy Metals	≤ 20 ppm

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