Description

Dotinurad Impurity 5 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Dotinurad by enabling accurate identification and quantification of related substances. It is an essential tool for analytical chemists and quality assurance professionals working in pharmaceutical R&D and manufacturing. The compound is supplied with comprehensive analytical data to support regulatory filings and internal quality standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analytical method development and validation of Dotinurad API.
• Quality Control (QC) Testing: Used in routine batch release testing to monitor and control impurity levels in accordance with ICH Q3A/B guidelines.
• Stability Studies: Employed as a marker to track impurity profiles in forced degradation and long-term stability studies of drug substances and products.
• Regulatory Compliance: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization.
• Research & Development: Aids in process chemistry optimization by identifying and quantifying synthetic by-products and degradation pathways.

Basic Information

Product Name	Dotinurad Impurity 5
CAS No.	1285573-47-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dotinurad Related Compound 5; Dotinurad Impurity C; 2-(3-Cyano-4-isobutoxyphenyl)-4-methyl-1,3-thiazole-5-carboxylic acid impurity; UR-1102 Impurity 5; UNII-9K9F8P8A4S; 1,3-Thiazole-5-carboxylic acid, 2-(3-cyano-4-isobutoxyphenyl)-4-methyl-
EINECS	Contact for details

Quality Control

Every batch of Dotinurad Impurity 5 is manufactured under a strict quality management system and undergoes comprehensive analytical characterization to ensure identity, purity, and consistency. Our products are supplied with a detailed Certificate of Analysis (COA) that includes data from advanced techniques such as HPLC, NMR, and MS. We support compliance with ICH, USP, and EP guidelines for impurity standards. Custom purity grades and analytical packages are available to meet specific project requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH limits

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