Description

Epalrestat Impurity CAS NO 109801-00-5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Epalrestat. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Epalrestat drug substance and finished products.
• Analytical Method Development & Validation: Used as a standard to develop, calibrate, and validate chromatographic methods (HPLC, UPLC) for quality control laboratories.
• Stability Studies: Employed as a marker compound to monitor the degradation pathways and stability of Epalrestat under various storage conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry R&D to study reaction pathways and optimize purification processes for Epalrestat.
• Quality Control Testing: Acts as a primary standard in routine QC testing to ensure batch-to-batch consistency and adherence to pharmacopeial specifications.

Basic Information

Product Name	Epalrestat Impurity
CAS No.	109801-00-5
Molecular Formula	C₁₅H₁₃NO₃S
Molecular Weight	287.33 g/mol
Synonyms	5-[(Z)-2-Methyl-3-phenylpropenylidene]-4-oxo-2-thioxo-3-thiazolidineacetic acid; (Z)-5-(2-Methyl-3-phenylallylidene)-4-oxo-2-thioxothiazolidine-3-acetic acid; Epalrestat Related Compound; Epalrestat Impurity Standard; Epalrestat Degradation Product; Epalrestat Process Impurity; Kinedak Impurity
EINECS	Contact for details

Quality Control

Our Epalrestat Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide full traceability and Certificates of Analysis (COA) that detail all test results against stringent in-house specifications, supporting compliance with cGMP and ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	Off-white to yellow powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single largest unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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