Description

Iguratimod Impurity 1 is a specified impurity of the active pharmaceutical ingredient (API) Iguratimod, used in the treatment of rheumatoid arthritis. This compound is critical for pharmaceutical manufacturers and analytical laboratories for quality control, method development, and regulatory compliance during the drug development and production process. It serves as a key reference standard for ensuring the purity, safety, and efficacy of the final drug product.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Iguratimod Impurity 1 in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing to monitor impurity levels and ensure they remain within International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) as part of drug stability testing.
• Research & Development (R&D): Used in synthetic chemistry research to understand the formation pathways of this impurity and to develop purification processes to minimize its presence.

Basic Information

Product Name	Iguratimod Impurity 1
CAS No.	123663-48-9
Molecular Formula	C17H14N2O3S
Molecular Weight	326.37 g/mol
Synonyms	N-[3-(Formylamino)-4-oxo-6-phenoxy-4H-chromen-7-yl]methanesulfonamide; Iguratimod Related Compound 1; T-614 Impurity 1; 7-(Methylsulfonamido)-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 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support your regulatory needs.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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