Description

Edaravone Impurity 27 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 Edaravone. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Edaravone API.
• Analytical Method Development and validation in HPLC, LC-MS, and other chromatographic systems.
• Quality Control (QC) and Quality Assurance (QA) testing in pharmaceutical manufacturing to meet ICH guidelines.
• Stability Studies to monitor impurity profiles in Edaravone formulations over time.
• Regulatory Compliance and submission support for drug master files (DMFs) and marketing applications.
• Research and Development for studying the degradation pathways and metabolism of Edaravone.

Basic Information

Product Name	Edaravone Impurity 27
CAS No.	1005763-87-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edaravone Related Compound 27; Edaravone EP Impurity G; Edaravone USP Impurity; 3-Methyl-1-phenyl-2-pyrazolin-5-one Impurity 27; MCI-186 Impurity 27; Radicava Impurity 27; 5-Pyrazolone derivative impurity; Edaravone Degradation Product
EINECS	Contact for details

Quality Control

Our Edaravone Impurity 27 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We support compliance with ICH Q3A/B, USP, and EP guidelines, and specifications can be tailored to meet specific pharmacopeial or client requirements.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 1.0%

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