Description

Iguratimod Impurity 28 is a designated 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 utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs departments to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Iguratimod Impurity 28 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 batch release 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 (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during the synthesis of Iguratimod, enabling process optimization.

Basic Information

Product Name	Iguratimod Impurity 28
CAS No.	1340086-28-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Iguratimod Related Compound 28; T-614 Impurity 28; 3-Formylamino-2-hydroxy-4-methoxy-4-oxobut-2-enoic acid (derivative); Iguratimod Process Impurity; Iguratimod Degradant; T-614 Metabolite Analog; Potential Iguratimod Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Iguratimod Impurity 28 is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and traceability.

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 solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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