Description

Lesinurad Impurity 4 is a designated impurity standard of the active pharmaceutical ingredient Lesinurad, a selective uric acid reabsorption inhibitor. This high-purity reference material is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable standards to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Lesinurad API and finished dosage forms.
• Analytical Method Development: Used to develop and optimize chromatographic methods (HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance: Serves as a system suitability standard and for routine batch release testing in GMP environments.
• Regulatory Compliance & Filing: Provides essential data for regulatory submissions (e.g., FDA, EMA) to establish impurity thresholds and control strategies.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions.
• Research & Development: Used in synthetic chemistry research to understand impurity formation pathways and in bioanalytical studies.

Basic Information

Product Name	Lesinurad Impurity 4
CAS No.	1533519-97-9
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 4; Lesinurad Impurity B; Lesinurad Process Impurity; 1-[4-Cyclopropyl-5-(5-bromo-4H-1,2,4-triazol-3-ylsulfanyl)naphthalen-1-yl]ethanone impurity
EINECS	Contact for details

Quality Control

Our Lesinurad Impurity 4 is manufactured under strict quality systems to ensure the highest standards of purity and consistency, suitable for use in regulated pharmaceutical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing identity, purity (by HPLC), and impurity profile. We support compliance with ICH Q3A/B guidelines and other relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment to maintain stability.

Specification

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