Description

Dotinurad Impurity 13 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the active pharmaceutical ingredient, Dotinurad. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable impurity standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Primary use as a pharmaceutical reference standard for method development and validation.
• Critical component in impurity profiling and stability studies of Dotinurad drug substance and drug products.
• Used in analytical research for HPLC, LC-MS, and other chromatographic techniques.
• Essential for quality control laboratories to identify and quantify this specific impurity batch-to-batch.
• Serves as a calibration standard in pharmacokinetic and metabolic studies.
• Supports regulatory filings (e.g., ANDA, NDA) by providing characterized impurity material.

Basic Information

Product Name	Dotinurad Impurity 13
CAS No.	888730-55-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dotinurad Related Compound 13; Dotinurad Impurity K; 1-[3-(4-Cyano-2-isopropoxyphenyl)-4-isopropyl-1H-pyrazol-5-yl]-3-(4-fluorophenyl)urea; UNII-9W2P2G8T9F; Dotinurad EP Impurity K; Dotinurad USP Impurity 13; Dotinurad Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Dotinurad Impurity 13 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the stringent requirements of pharmaceutical reference standard applications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results of all specified tests.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-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
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
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.