Description

Edaravone Impurity 26 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: Used as a certified impurity standard for the quality control and release testing of Edaravone API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to accurately identify and quantify this specific impurity.
• Stability Studies: Employed to monitor the formation and level of Edaravone Impurity 26 in drug substances and products under various storage conditions.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data required for drug master files (DMFs) and dossiers.
• Research & Development: Used in R&D to study the degradation pathways, synthesis impurities, and metabolic profiles of Edaravone.
• Pharmacopoeial Testing: Serves as a reference material for testing against monographs in pharmacopoeias such as USP, EP, or JP.

Basic Information

Product Name	Edaravone Impurity 26
CAS No.	152494-76-3
Molecular Formula	C14H10N2O3
Molecular Weight	254.24 g/mol
Synonyms	3-Methyl-1-phenyl-2-pyrazolin-5-one Impurity; Edaravone Related Compound 26; 5-Hydroxy-3-methyl-1-phenyl-1H-pyrazol-4-carbaldehyde; 3-Methyl-1-phenyl-1H-pyrazol-5-ol-4-carboxaldehyde; 4-Formyl-5-hydroxy-3-methyl-1-phenyl-1H-pyrazole; Edaravone Aldehyde Impurity; 1-Phenyl-3-methyl-4-formyl-5-pyrazolone
EINECS	Contact for details

Quality Control

Our Edaravone Impurity 26 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

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, consider storing desiccated at 2-8°C.

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

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