Description

Lesinurad Impurity J is a specified impurity and degradation product of the active pharmaceutical ingredient Lesinurad. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity chemical reference materials to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Lesinurad active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A and Q3B guidelines.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during Lesinurad synthesis, helping to refine manufacturing processes.

Basic Information

Product Name	Lesinurad Impurity J
CAS No.	1210330-64-5
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 J; Lesinurad EP Impurity J; Lesinurad USP Impurity J; Lesinurad Process Impurity; 1-Cyclopropyl-4-[5-(mercaptomethyl)-4H-1,2,4-triazol-4-yl]naphthalene Impurity
EINECS	Contact for details

Quality Control

Our Lesinurad Impurity J is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and quality. Each batch is characterized using advanced techniques including HPLC, GC, MS, and NMR spectroscopy. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial standards. Our quality system is designed to meet the stringent requirements of pharmaceutical reference material users.

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 in a desiccated environment to maintain stability and purity. The container should be sealed under an inert atmosphere if possible.

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

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