Description

Lesinurad Impurity 10 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the accurate identification, quantification, and control of process-related impurities during the manufacturing of Lesinurad, a medication used to treat hyperuricemia associated with gout. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, ensuring product safety and regulatory compliance. The reliable supply of this well-characterized impurity standard is fundamental for maintaining the integrity of the drug development and production lifecycle.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for method development and validation in HPLC and LC-MS analysis.
• Quality Control & Assurance: Used for establishing acceptance criteria and monitoring impurity profiles in Lesinurad Active Pharmaceutical Ingredient (API) batches.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Stability Studies: Employed as a marker to track the formation of specific degradation products under various stress conditions.
• Process Chemistry Research: Aids chemists in optimizing synthesis pathways to minimize the formation of this specific impurity.
• Analytical Method Transfer: Serves as a system suitability test component when transferring QC methods between laboratories or sites.

Basic Information

Product Name	Lesinurad Impurity 10
CAS No.	1533519-94-6
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 (IUPAC); Lesinurad Related Compound 10; Lesinurad Process Impurity; UR-1102 Impurity; RDEA594 Impurity
EINECS	Contact for details

Quality Control

Every batch of Lesinurad Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); containers must be kept tightly sealed and protected from humidity to maintain stability and purity.

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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