Description

Edaravone Impurity P3 is a high-purity 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: Used as a certified reference material (CRM) for the identification and quantification of impurities in Edaravone API and finished drug products.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor process-related impurities.
• Quality Control & Assurance: Serves as a system suitability and calibration standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability testing of Edaravone formulations.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Edaravone.

Basic Information

Product Name	Edaravone Impurity P3
CAS No.	1323485-71-7
Molecular Formula	C12H10N2O2
Molecular Weight	214.22 g/mol
Synonyms	Edaravone Related Compound P3; Edaravone Impurity 3; 3-Methyl-1-phenyl-2-pyrazolin-5-one Impurity P3; 1-Phenyl-3-methyl-5-pyrazolone Impurity; Radicut Impurity P3; MCI-186 Impurity P3; 5-Pyrazolone, 1-phenyl-3-methyl-, impurity; (Z)-2-Phenyl-2-(hydroxyimino)-N-(3-methyl-1-phenyl-1H-pyrazol-5-yl)acetamide
EINECS	Contact for details

Quality Control

Our Edaravone Impurity P3 is manufactured under strict quality control conditions to meet the rigorous standards of the pharmaceutical industry. Each batch is thoroughly 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 each shipment, detailing all test results and confirming compliance with relevant ICH Q3B(R2) guidelines for impurities.

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 storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 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.