Description

Lesinurad Impurity K is a specified impurity and degradation product of the active pharmaceutical ingredient Lesinurad. This compound is critical for pharmaceutical research and development, particularly in the analytical method development and validation required for drug substance and product quality control. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs professionals to ensure the safety, efficacy, and compliance of Lesinurad-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Lesinurad Impurity K in drug substances and finished products.
• Analytical Method Development: Used in the development and optimization of chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Stability Studies: Essential for monitoring impurity levels during stability testing to establish shelf-life and storage conditions for Lesinurad formulations.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Process Chemistry Research: Used to study the formation pathways of this impurity during the synthesis and manufacturing of Lesinurad, aiding in process optimization.
• Pharmacopoeial Testing: Employed in testing to meet the specifications outlined in pharmacopoeial monographs (e.g., USP, EP) for Lesinurad.

Basic Information

Product Name	Lesinurad Impurity K
CAS No.	1533519-96-8
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 K; Lesinurad Impurity 11; Lesinurad EP Impurity K; Lesinurad USP Impurity K; 1-Cyclopropyl-4-[5-[(carboxymethyl)thio]-4-(4-fluorophenyl)-4H-1,2,4-triazol-3-yl]naphthalene (mis-assigned name check); Lesinurad Bromo Impurity
EINECS	Contact for details

Quality Control

Our Lesinurad Impurity K is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). Certificates of Analysis (COA) are provided, detailing batch-specific results for identity, purity, and impurities. The material is suitable for use as a pharmaceutical reference standard in compliance with ICH guidelines Q3A(R2) and Q3B(R2).

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% 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.