Description

Edaravone Impurity 26 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities in Edaravone drug substances and finished products. It is primarily used by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and biotechnology industries to ensure product safety, efficacy, and compliance with stringent global regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Edaravone.
• Method Development and Validation: Used in developing and validating analytical methods, particularly HPLC and LC-MS, for impurity profiling.
• Quality Control and Batch Release: Critical for establishing impurity limits and ensuring the consistency and purity of commercial Edaravone batches.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to monitor impurity levels in Edaravone formulations under various storage conditions over time.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Edaravone to minimize impurity formation.

Basic Information

Product Name	Edaravone Impurity 26
CAS No.	67790-05-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edaravone Related Compound 26; Edaravone Impurity F; 3-Methyl-1-phenyl-2-pyrazolin-5-one Impurity 26; MCI-186 Impurity 26; Radicava Impurity 26; 5-Pyrazolone derivative impurity; Process impurity of Edaravone
EINECS	Contact for details

Quality Control

Every batch of Edaravone Impurity 26 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing results from tests such as HPLC purity, related substances, residual solvents, and spectroscopic identification, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.