Description

Iguratimod Impurity 5 is a specified impurity of the active pharmaceutical ingredient Iguratimod, a disease-modifying antirheumatic drug (DMARD). This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and validation. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories to ensure the purity, safety, and efficacy of Iguratimod drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Iguratimod Impurity 5 in drug substances and finished products.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC/UPLC methods for Iguratimod.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Iguratimod to minimize impurity formation.

Basic Information

Product Name	Iguratimod Impurity 5
CAS No.	84594-95-6
Molecular Formula	C17H14N2O3S
Molecular Weight	326.37 g/mol
Synonyms	N-Formyl Iguratimod; 3-Formamido-2-hydroxy-2-methyl-N-[4-(methylsulfinyl)phenyl]propanamide; Iguratimod Related Compound; T-614 Impurity; 3-(Formylamino)-2-hydroxy-2-methyl-N-[4-(methylsulfinyl)phenyl]propanamide; (RS)-3-(Formylamino)-2-hydroxy-2-methyl-N-[4-(methylsulfinyl)phenyl]propanamide
EINECS	Contact for details

Quality Control

Every batch of Iguratimod Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with ICH guidelines and customer-specific requirements. Comprehensive Certificates of Analysis (COA) detailing batch-specific results from advanced analytical techniques (HPLC, NMR, MS) are provided and available upon request.

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 storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to 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
Residual Solvents (GC)	Complies with ICH Q3C

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