Description

Edaravone Impurity 10 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, UPLC, and LC-MS systems.
• Quality Control (QC) and Quality Assurance (QA) testing in pharmaceutical manufacturing.
• Stability Studies to monitor impurity profiles in Edaravone formulations over time.
• Regulatory Compliance and submission support for drug master files (DMFs).
• Research & Development of new synthetic pathways and purification processes for Edaravone.

Basic Information

Product Name	Edaravone Impurity 10
CAS No.	710307-89-4
Molecular Formula	C10H10N2O2
Molecular Weight	190.20 g/mol
Synonyms	3-Methyl-1-phenyl-2-pyrazolin-5-one Impurity; 3-Methyl-1-phenyl-5-pyrazolone Related Compound; Edaravone Related Compound; 1-Phenyl-3-methyl-5-pyrazolone Impurity; 3-Methyl-1-phenyl-1H-pyrazol-5(4H)-one Impurity; MCI-186 Impurity 10; Radicava Impurity 10
EINECS	Contact for details

Quality Control

Our Edaravone Impurity 10 is manufactured under strict quality control protocols to meet the stringent requirements of pharmaceutical reference standards. Each batch is characterized and tested using validated analytical methods, including HPLC, NMR, and MS, to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing all test results and confirming compliance with in-house specifications.

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 reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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