Description

Iguratimod Impurity 14 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 finished products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Iguratimod API.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance: Used in routine QC testing of Iguratimod batches to ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation and levels of this impurity during forced degradation and long-term stability testing of drug products.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify the control strategy.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during API synthesis, helping to optimize manufacturing processes.

Basic Information

Item	Details
Product Name	Iguratimod Impurity 14
CAS No.	150831-14-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Iguratimod Related Compound 14; T-614 Impurity 14; 3-Formylamino-2-hydroxy-4-methoxy-4-oxobut-2-enoic acid; 3-(Formylamino)-2-hydroxy-4-methoxy-4-oxo-2-butenoic acid; Iguratimod EP Impurity H; Iguratimod Impurity H (EP); Iguratimod Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Iguratimod Impurity 14 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment ensures material suitability for its intended use in regulated pharmaceutical analysis.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material is light-sensitive (store away from light). Keep the container tightly sealed in a dry and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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