Description

Edaravone Impurity 12 is a high-purity reference standard used for the analytical profiling and quality control of the pharmaceutical agent Edaravone. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory compliance teams focused on method development and validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for calibrating analytical instruments and validating testing methods.
• Analytical Method Development: Crucial for developing and optimizing HPLC, UPLC, and LC-MS methods for impurity profiling of Edaravone Active Pharmaceutical Ingredient (API) and finished formulations.
• Quality Control & Assurance: Used in routine batch testing to monitor and control the levels of specified impurities, ensuring compliance with pharmacopeial limits (e.g., ICH Q3A/B guidelines).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for impurity identification.
• Stability Studies: Employed to track the formation of degradation products in Edaravone formulations under various stress conditions.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthetic pathway of Edaravone to minimize the formation of this specific impurity.

Basic Information

Product Name	Edaravone Impurity 12
CAS No.	2061958-41-4
Molecular Formula	C12H10N2O2
Molecular Weight	214.22 g/mol
Synonyms	3-Methyl-1-phenyl-2-pyrazolin-5-one Impurity 12; 1-Phenyl-3-methyl-2-pyrazolin-5-one Related Compound 12; Edaravone Related Compound 12; Radicava Impurity 12; MCI-186 Impurity 12; 5-Pyrazolone derivative impurity; (Z)-2-(1-Phenyl-3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-4-ylidene)hydrazine-1-carboxamide
EINECS	Contact for details

Quality Control

Every batch of Edaravone Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, 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 (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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