Description

Edaravone Impurity 12 is a high-purity 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. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The precise characterization of this impurity is essential for meeting stringent pharmacopeial and regulatory compliance standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Edaravone API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, validating, and calibrating chromatographic methods, such as HPLC and UPLC, for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring product consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation and behavior of this specific impurity under various stress conditions and over the shelf-life of the drug.
• Research & Development: Supports synthetic route optimization, degradation pathway studies, and impurity fate and tolerance investigations during API process development.

Basic Information

Product Name	Edaravone Impurity 12
CAS No.	82772-85-8
Molecular Formula	C12H10N2O2
Molecular Weight	214.22 g/mol
Synonyms	3-Methyl-1-phenyl-2-pyrazolin-5-one Impurity; 1-Phenyl-3-methyl-5-pyrazolone Related Compound; Edaravone Related Compound; 5-Pyrazolone, 1-phenyl-3-methyl-; 1-Phenyl-3-methyl-5-pyrazolone; 3-Methyl-1-phenyl-5-pyrazolone; PMP; 82772-85-8
EINECS	Contact for details

Quality Control

Our Edaravone Impurity 12 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatograms and spectra, is provided with every shipment to guarantee traceability and reliability for your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, keep the container under inert atmosphere to prevent potential oxidation.

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 individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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