Description

Lesinurad Impurity N is a specified impurity and degradation product associated with the active pharmaceutical ingredient Lesinurad. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Lesinurad drug substances and products.

Application

• Primary use as a certified reference standard for the identification and quantification of Lesinurad Impurity N in active pharmaceutical ingredients (APIs).
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for impurity profiling.
• Essential for quality control and assurance laboratories in pharmaceutical manufacturing to monitor impurity levels against ICH guidelines.
• Used in stability studies to understand the degradation pathways of Lesinurad under various stress conditions.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data.
• Valuable for research and development of synthetic routes and purification processes for Lesinurad.

Basic Information

Product Name	Lesinurad Impurity N
CAS No.	1533519-99-1
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 N; Lesinurad Impurity 7; Lesinurad EP Impurity N; Lesinurad USP Impurity N; RDEA594 Impurity N; Zurampic Impurity N
EINECS	Contact for details

Quality Control

Every batch of Lesinurad Impurity N is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure high purity and identity, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for purity (HPLC), identification (IR, NMR), and other relevant analytical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.