Description

Lesinurad Impurity 5 Sodium Salt is a high-purity reference standard critical for analytical and regulatory purposes in pharmaceutical development. This compound is essential for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Lesinurad by accurately identifying and quantifying this specific impurity. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, quality control, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Lesinurad Impurity 5 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine impurity monitoring in pharmaceutical quality control laboratories to ensure batch-to-batch consistency.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions during drug product stability testing.
• Research & Development: Used in pharmacokinetic, metabolic, and toxicological studies to understand the impurity's profile and impact.

Basic Information

Product Name	Lesinurad Impurity 5 Sodium Salt
CAS No.	1384208-36-9
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 sodium salt; Sodium 2-((5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-yl)thio)acetate; Lesinurad Related Compound 5 Sodium Salt; Lesinurad Sodium Salt Impurity 5
EINECS	Contact for details

Quality Control

Our Lesinurad Impurity 5 Sodium Salt is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and conformity to stringent specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality assurance requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
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.