Description

Lesinurad Impurity L CAS NO 1158970-49-0 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 regulatory purposes in pharmaceutical development and quality control. It is essential for researchers and manufacturers in the pharmaceutical industry who require high-purity chemical standards to ensure drug safety, efficacy, and compliance with stringent regulatory guidelines.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Lesinurad active pharmaceutical ingredient (API) and finished drug products.
• Critical component in analytical method development and validation (e.g., HPLC, UPLC, LC-MS) for impurity profiling.
• Used in stability studies to monitor impurity formation under various stress conditions.
• Essential for regulatory submissions (e.g., to FDA, EMA) to establish impurity thresholds and control strategies.
• Serves as a research chemical in metabolic and pharmacokinetic studies related to Lesinurad.
• Supports quality assurance/quality control (QA/QC) laboratories in maintaining batch-to-batch consistency.

Basic Information

Product Name	Lesinurad Impurity L
CAS No.	1158970-49-0
Molecular Formula	C17H14BrN3O4S
Molecular Weight	436.28 g/mol
Synonyms	2-(5-Bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)acetic Acid; Lesinurad Related Compound L; RDEA594 Impurity L; 1-Cyclopropyl-4-((5-bromo-4-((carboxymethyl)thio)-4H-1,2,4-triazol-3-yl))naphthalene; Lesinurad EP Impurity L; Lesinurad USP Impurity L; Lesinurad Process Impurity L
EINECS	Contact for details

Quality Control

Our Lesinurad Impurity L is manufactured under strict quality systems to meet the exacting standards of pharmaceutical impurity analysis. Each batch undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

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 ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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