Description

Iguratimod Impurity 11 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 drug purity, safety, and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Iguratimod Impurity 11 in drug substance and finished product analysis.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Iguratimod.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency of Iguratimod API according to ICH guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Critical for preparing impurity data packages required for regulatory filings (e.g., with FDA, EMA) for new drug applications (NDA) or abbreviated new drug applications (ANDA).
• 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 11
CAS No.	149457-04-5
Molecular Formula	C17H14N2O3S
Molecular Weight	326.37 g/mol
Synonyms	N-Formyl Iguratimod; 3-Formamido-2-hydroxy-2-methyl-N-[4-(trifluoromethyl)phenyl]propanamide; T-614 Impurity 11; Iguratimod Related Compound 11; 3-(Formylamino)-2-hydroxy-2-methyl-N-[4-(trifluoromethyl)phenyl]propanamide; 2-Hydroxy-2-methyl-3-[[(4-trifluoromethyl)phenyl]amino]carbonyl]amino]propanoic acid formyl derivative
EINECS	Contact for details

Quality Control

Every batch of Iguratimod Impurity 11 is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our products are characterized using advanced techniques including HPLC, MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A, Q3B, and Q6A guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.