Description

Lesinurad Impurity 19 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient Lesinurad by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing. The availability of this well-characterized impurity supports compliance with stringent global regulatory requirements for drug substance purity.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the analytical method development and validation of Lesinurad API.
• Impurity Profiling and Identification: Essential for identifying and quantifying this specific impurity in Lesinurad drug substance and finished dosage forms during stability and release testing.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Regulatory Submissions: Supports the preparation of regulatory filings (e.g., DMF, CMC sections) by providing definitive characterization data for specified impurities.
• Research and Development: Utilized in pharmaceutical R&D to study the formation, fate, and purge of process-related impurities.
• Stability Studies: Acts as a marker to track impurity formation under various stress conditions (heat, light, humidity) as per ICH stability protocols.

Basic Information

Product Name	Lesinurad Impurity 19
CAS No.	2250243-55-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lesinurad Related Compound 19; Lesinurad Specified Impurity 19; 2-((5-Bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-yl)thio)acetic acid (tentative); UR-1102 Impurity 19; RDEA594 Impurity 19; Lesinurad Process Impurity; Lesinurad Degradant
EINECS	Contact for details

Quality Control

Every batch of Lesinurad Impurity 19 is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to confirm identity, purity, and strength. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results against predefined specifications. Our quality commitment aligns with cGMP principles and supports compliance with pharmacopeial standards (USP, EP) for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
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.