Description

Edaravone Impurity 11 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Edaravone through rigorous impurity profiling and method validation. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on quality control and compliance in drug development and production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Edaravone (Radicava).
• Analytical Method Development: Used in developing and validating HPLC, UPLC, and GC methods for impurity detection and quantification.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions.
• Regulatory Compliance & Filing: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry and metabolic pathway studies related to Edaravone.
• Quality Assurance/Quality Control (QA/QC): Used for system suitability testing, calibration, and routine batch release testing in pharmaceutical manufacturing.

Basic Information

Product Name	Edaravone Impurity 11
CAS No.	27301-70-8
Molecular Formula	C12H10N2O2
Molecular Weight	214.22 g/mol
Synonyms	1-Phenyl-3-methyl-5-pyrazolone impurity; 3-Methyl-1-phenyl-2-pyrazolin-5-one related compound; Edaravone Related Compound; 5-Pyrazolone, 1-phenyl-3-methyl-; 1-Phenyl-3-methyl-5-pyrazolone; PMP; 3-Methyl-1-phenyl-5-pyrazolone
EINECS	Contact for details

Quality Control

Every batch of Edaravone Impurity 11 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Loss on Drying	≤ 1.0%
Residue on Ignition	≤ 0.1%

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