Description

Irsogladine Impurity Dqj 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 drug Irsogladine Maleate. It is primarily utilized by research scientists and quality assurance professionals in the pharmaceutical and biotechnology industries to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development and validation in HPLC, LC-MS, and other chromatographic systems.
• Quality Control & Assurance (QC/QA): Used for the identification, qualification, and quantification of impurities in Irsogladine Maleate active pharmaceutical ingredient (API) and finished drug products.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Research & Development (R&D): Employed in stability studies, degradation pathway elucidation, and process chemistry research to understand and control impurity formation.
• Contract Research & Testing Laboratories: A key material for third-party labs offering analytical testing and certification services to pharmaceutical manufacturers.

Basic Information

Product Name	Irsogladine Impurity Dqj
CAS No.	61382-84-1
Molecular Formula	C9H7ClN4O2S
Molecular Weight	270.69 g/mol
Synonyms	2-[(4-Chloro-2-methylphenyl)amino]-5-sulfamoyl-1,3,4-thiadiazole; Irsogladine Related Compound D; Irsogladine EP Impurity D; Irsogladine Maleate Impurity D; 1,3,4-Thiadiazole-2-amine, N-(4-chloro-2-methylphenyl)-5-(aminosulfonyl)-; 5-(Aminosulfonyl)-N-(4-chloro-2-methylphenyl)-1,3,4-thiadiazol-2-amine
EINECS	Contact for details

Quality Control

Every batch of Irsogladine Impurity Dqj is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
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.