Description

Iguratimod Impurity 10 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 for analytical method development, validation, and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Iguratimod drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Iguratimod API and formulations.
• Analytical Method Development: Crucial for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Used in routine QC testing of batches to ensure compliance with pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (light, heat, 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 10
CAS No.	149456-97-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Iguratimod Related Compound 10; Iguratimod EP Impurity J; T-614 Impurity 10; 3-Formylamino-2-hydroxy-4-methoxy-4-oxobut-2-enoic acid; (Z)-3-(Formylamino)-2-hydroxy-4-methoxy-4-oxobut-2-enoic acid; Iguratimod Impurity J; Iguratimod Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Iguratimod Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) methods to ensure compliance with pharmacopeial and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Assay (HPLC)	90.0% - 110.0% of labeled amount
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.