Description

Dotinurad Impurity 11 is a designated impurity standard of the uricosuric agent Dotinurad. This high-purity reference material is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) during development and manufacturing. It is primarily required by pharmaceutical companies and analytical laboratories for method development, validation, and routine quality control testing. The compound is supplied with comprehensive analytical data to support regulatory submissions and compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quantitative and qualitative analysis of Dotinurad API and finished dosage forms.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control & Assurance: Employed in routine batch release testing to monitor and control impurity levels, ensuring product specifications are met.
• Regulatory Compliance: Supports regulatory filings (e.g., FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to identify and quantify degradation products that may form under various stress conditions during drug product shelf-life studies.
• Research and Development: Serves as a critical tool in process chemistry for impurity profiling and optimization of synthetic routes for Dotinurad.

Basic Information

Product Name	Dotinurad Impurity 11
CAS No.	1285572-54-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dotinurad Related Compound 11; Dotinurad Impurity; 1-[3-(4-Cyano-2-isopropoxyphenyl)-4-isoxazolyl]-3-(4-hydroxybutyl)urea; UNII-8Q7Q5F5Q5T; Dotinurad Process Impurity; Dotinurad Degradant; Dotinurad Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Dotinurad Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (MS, NMR) techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and spectral data. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material under appropriate laboratory conditions to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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