Description

Perampanel 3/4 Hydrate is a specific hydrate form of the active pharmaceutical ingredient Perampanel, a non-competitive AMPA receptor antagonist. This compound is of critical importance for pharmaceutical research and development, particularly in the area of central nervous system (CNS) therapeutics. It serves as a key intermediate and reference standard for the synthesis and quality control of the final drug substance used in antiepileptic medications. This product is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on neurology and drug development.

Application

• Active Pharmaceutical Ingredient (API) Intermediate: A crucial building block in the synthesis of the final Perampanel drug substance.
• Pharmaceutical Reference Standard: Used for analytical method development, validation, and quality control testing (e.g., HPLC, LC-MS) to ensure batch consistency and purity.
• Research & Development: Fundamental material for preclinical and clinical research studies investigating AMPA receptor modulation.
• Antiepileptic Drug Development: Core component in the development and manufacturing of medications for partial-onset and generalized tonic-clonic seizures.
• Process Chemistry & Scale-Up: Used in optimizing synthetic routes and scaling production processes from laboratory to commercial scale.
• Regulatory Filings: Serves as a characterized material for inclusion in regulatory submission dossiers (e.g., for FDA, EMA).

Basic Information

Product Name	Perampanel 3/4 Hydrate
CAS No.	1571982-04-1
Molecular Formula	C23H15N3O • 0.75H2O
Molecular Weight	363.40 g/mol (anhydrous basis)
Synonyms	2-(2-Oxo-1-phenyl-5-pyridin-2-yl-1,2-dihydropyridin-3-yl)benzonitrile 3/4 Hydrate; Fycompa Impurity; Fycompa Intermediate; E2007; AMPA Receptor Antagonist; (3S)-2-(2-Oxo-1-phenyl-5-(pyridin-2-yl)-1,2-dihydro-3H-pyridin-3-yl)benzonitrile Hemipentahydrate
EINECS	Contact for details

Quality Control

Our Perampanel 3/4 Hydrate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, meeting high standards for pharmaceutical applications. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting key parameters such as assay, related substances, and residual solvents. We support compliance with cGMP and ICH guidelines for pharmaceutical intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0% (on anhydrous basis)
Water Content (KF)	2.5% - 4.5% (Theoretical for 3/4 hydrate: ~3.7%)
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
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.