Description

Dotinurad Impurity 1 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Dotinurad. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Dotinurad API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure compliance with pharmacopeial (e.g., ICH, USP) impurity limits.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the manufacturing process and product quality.
• Research & Development: Supports process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Dotinurad Impurity 1
CAS No.	1285573-44-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dotinurad Related Compound 1; Dotinurad Impurity A; Dotinurad Process Impurity; 1-(3-(4-cyanobenzyl)-4-fluorophenyl)-3-(2-hydroxyethyl)urea (proposed); UR-1102 Impurity; UNII-Contact for details; Dotinurad Specified Impurity
EINECS	Contact for details

Quality Control

Our Dotinurad Impurity 1 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity, ensuring it meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with every shipment, containing batch-specific data on purity, impurities, and chromatographic profile.

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. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider conditions recommended for high-purity organic reference standards.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (NMR/IR)	Spectrum consistent with reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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