Description

Iguratimod Impurity 9 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Iguratimod. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for the production of Iguratimod, a medication used in the treatment of rheumatoid arthritis.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Iguratimod API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure API and drug product specifications meet pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions (e.g., heat, light, humidity) to determine product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Iguratimod to minimize the formation of this impurity.

Basic Information

Product Name	Iguratimod Impurity 9
CAS No.	1179354-65-4
Molecular Formula	C17H14N2O3S
Molecular Weight	326.37 g/mol
Synonyms	N-[3-(Formylamino)-4-oxo-6-phenoxy-4H-chromen-7-yl]methanesulfonamide; 7-[(Methylsulfonyl)amino]-4-oxo-6-phenoxy-4H-1-benzopyran-3-carboxaldehyde; T-614 Impurity 9; Iguratimod Related Compound 9; 3-Formyl-7-methanesulfonamido-6-phenoxy-4H-chromen-4-one
EINECS	Contact for details

Quality Control

Every batch of Iguratimod Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with industry and regulatory standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical parameters.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed 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 powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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