Description

Lesinurad Impurity A is a specified impurity of the active pharmaceutical ingredient Lesinurad, a medication used for the treatment of hyperuricemia associated with gout. This impurity is a critical reference standard in pharmaceutical research and development, essential for ensuring drug safety, efficacy, and regulatory compliance. It is primarily required by analytical laboratories, quality control units, and R&D departments within the pharmaceutical industry for method development, validation, and routine batch analysis.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Lesinurad Impurity A in drug substance and finished product analysis.
• Analytical Method Development & Validation: Used to establish and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling of Lesinurad.
• Quality Control & Batch Release: Critical for routine quality control testing to monitor impurity levels and ensure batches meet International Council for Harmonisation (ICH) guidelines and pharmacopeial specifications.
• Stability Studies: Employed as an analytical marker to track impurity formation during forced degradation and long-term stability studies of Lesinurad formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Process Chemistry Research: Used by chemists to understand and optimize synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Lesinurad Impurity A
CAS No.	1533519-98-0
Molecular Formula	C17H14BrN3O3S
Molecular Weight	420.28 g/mol
Synonyms	1-(4-Bromo-3-(4-cyclopropylnaphthalen-1-yl)-4,5-dihydro-1H-pyrazol-5-yl)-3-(4-cyanophenyl)urea; Lesinurad Related Compound A; Lesinurad EP Impurity A; Lesinurad USP Impurity A; 2-[(4-Bromo-3-[4-cyclopropyl-1-naphthyl]-4,5-dihydro-1H-pyrazol-5-yl)carbamoyl]benzonitrile (related structure); Lesinurad Process Impurity; ZURAMPIC Impurity A
EINECS	Contact for details

Quality Control

Our Lesinurad Impurity A is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for use as a pharmaceutical reference standard. Each batch is characterized and qualified using advanced techniques including HPLC, GC, MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

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)	Individual unspecified impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay	97.0% - 103.0% (on anhydrous basis)

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