Description

Iguratimod Impurity 2 is a specified impurity of the active pharmaceutical ingredient (API) Iguratimod, a disease-modifying anti-rheumatic drug (DMARD). This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Iguratimod drug substances and products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Iguratimod API and finished drug products.
• Analytical Method Development: Critical for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Iguratimod meets stringent pharmacopeial (e.g., USP, EP, JP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this impurity.

Basic Information

Product Name	Iguratimod Impurity 2
CAS No.	123662-92-0
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 2; Iguratimod Related Compound 2; Iguratimod EP Impurity B; Iguratimod USP Impurity; 2-Hydroxy-2-methyl-3-[(phenylcarbonyl)amino]-N-[4-(trifluoromethyl)phenyl]propanamide (related formyl derivative)
EINECS	Contact for details

Quality Control

Every batch of Iguratimod Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 should be kept in a desiccated environment to prevent moisture absorption. 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%
Assay	97.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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