Description

Lesinurad Impurity C1 is a designated impurity standard of the active pharmaceutical ingredient Lesinurad. This compound is critical for pharmaceutical research and development, serving as a key reference marker for analytical method development and validation. It is primarily utilized by quality control laboratories and regulatory affairs departments within the pharmaceutical industry to ensure product purity, safety, and compliance with stringent international guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Lesinurad Impurity C1 in drug substances and finished products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Acts as a benchmark in forced degradation and long-term stability studies to track impurity formation over time.
• Process Chemistry R&D: Used by synthetic chemists to understand and mitigate the formation of this impurity during the manufacturing process.

Basic Information

Product Name	Lesinurad Impurity C1
CAS No.	1038366-57-2
Molecular Formula	C17H14BrN3O3S
Molecular Weight	420.28 g/mol
Synonyms	2-(5-Bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)acetic Acid; Lesinurad Related Compound C1; Lesinurad EP Impurity C; Lesinurad USP Impurity C1; 1-Cyclopropyl-4-((5-((carboxymethyl)thio)-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-yl))naphthalene; RDEA594 Impurity C1; Zurampic Impurity C1
EINECS	Contact for details

Quality Control

Our Lesinurad Impurity C1 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity, and impurity profiles. The quality standards align with the requirements for pharmaceutical reference materials, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under appropriate conditions to prevent degradation.

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 unspecified impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5%
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.