Description

Lesinurad Impurity 12 is a designated impurity standard associated with the active pharmaceutical ingredient Lesinurad. This compound is critical for analytical research and quality control processes in pharmaceutical development and manufacturing. It is primarily used by researchers and quality assurance professionals in the pharmaceutical industry to ensure the purity, safety, and efficacy of Lesinurad-based drug products. The availability of this well-characterized impurity standard is essential for method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Lesinurad API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring product consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Stability Studies: Used as a marker to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during the synthesis of Lesinurad, enabling process optimization.

Basic Information

Item	Details
Product Name	Lesinurad Impurity 12
CAS No.	1547295-28-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-[3-Bromo-4-(cyclopropylamino)phenyl]-3-(4-cyanophenyl)urea; Lesinurad Related Compound 12; Lesinurad Impurity B (Check with supplier); Lesinurad Process Impurity; UR-1102 Impurity; Zurampic Impurity 12
EINECS	Contact for details

Quality Control

Our Lesinurad Impurity 12 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided, detailing results from tests such as HPLC purity, related substances, and residual solvents, in alignment with ICH Q3A and Q3B guidelines. Our quality commitment supports your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Single Unknown Impurity	≤ 1.0%
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.