Description

Iguratimod Impurity 3 is a specified impurity of the active pharmaceutical ingredient Iguratimod, a disease-modifying anti-rheumatic drug (DMARD). This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Iguratimod drug substances and products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of Iguratimod Impurity 3.
• Essential for method development and validation of analytical procedures (e.g., HPLC, UPLC) in quality control laboratories.
• Used in stability studies and impurity profiling to monitor degradation pathways of Iguratimod formulations.
• Critical for regulatory submissions (e.g., ANDA, NDA) to establish impurity limits as per ICH Q3A and Q3B guidelines.
• Supports research and development of Iguratimod synthesis processes for impurity control and route optimization.
• Utilized in pharmacopeial testing to comply with monograph specifications for Iguratimod.

Basic Information

Product Name	Iguratimod Impurity 3
CAS No.	123664-52-8
Molecular Formula	C17H14N2O3S
Molecular Weight	326.37 g/mol
Synonyms	N-[3-(Formylamino)-4-oxo-6-phenoxy-4H-chromen-7-yl]methanesulfonamide; T-614 Impurity 3; Iguratimod Related Compound 3; 7-[(Methylsulfonyl)amino]-4-oxo-6-phenoxy-4H-1-benzopyran-3-carboxaldehyde; 3-Formyl-7-methanesulfonamido-6-phenoxychromen-4-one
EINECS	Contact for details

Quality Control

Our Iguratimod Impurity 3 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles as determined by validated analytical methods (HPLC, NMR, MS). Our quality commitment aligns with ICH guidelines and supports compliance in cGMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.2%

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