Description

Dotinurad Impurity 2 CAS NO 1285572-55-5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Dotinurad during its development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and quality control laboratories for method validation, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Dotinurad API batches.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions as per ICH guidelines.
• Regulatory Submissions: Essential for preparing impurity data packages required for drug master files (DMFs), ANDAs, and other regulatory filings with agencies like the FDA and EMA.
• Chemical Research: Used in academic and industrial research to study the metabolism, degradation pathways, and chemical behavior of Dotinurad.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine quality control testing to ensure batch-to-batch consistency.

Basic Information

Product Name	Dotinurad Impurity 2
CAS No.	1285572-55-5
Molecular Formula	C17H14FN3O4S
Molecular Weight	375.37 g/mol
Synonyms	1-[3-(4-Fluorobenzyl)-4-(methylsulfonyl)phenyl]-3-(4-hydroxybutyl)urea; Dotinurad Related Compound 2; Dotinurad Impurity B; UNII-9V8Q5B2V0I; 1-[3-[(4-Fluorophenyl)methyl]-4-(methylsulfonyl)phenyl]-3-(4-hydroxybutyl)urea; UR-1102 Impurity; (4-{3-[3-(4-Fluorobenzyl)-4-(methylsulfonyl)phenyl]ureido}butan-1-ol)
EINECS	Contact for details

Quality Control

Our Dotinurad Impurity 2 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to ensure full traceability and compliance with cGMP and ICH Q3A/B guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere when appropriate to ensure long-term stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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