Description

Eslicarbazepine is a high-purity active pharmaceutical ingredient (API) and a key metabolite of oxcarbazepine. This compound is of significant commercial and therapeutic importance as the primary active component in the antiepileptic drug eslicarbazepine acetate. It is essential for pharmaceutical manufacturers and research institutions focused on developing and producing advanced central nervous system (CNS) medications. The material is supplied to meet the stringent requirements of global pharmacopeial standards.

Application

• Primary Active Pharmaceutical Ingredient (API): Direct synthesis and formulation of the antiepileptic drug eslicarbazepine acetate.
• Pharmaceutical Intermediates: Serves as a critical intermediate in the production of related anticonvulsant and neuropathic pain medications.
• Research & Development: Used in preclinical and clinical studies for investigating new therapeutic applications in neurology.
• Reference Standard: Employed as a high-purity analytical standard in quality control laboratories for HPLC, LC-MS, and other chromatographic methods.
• Generic Drug Manufacturing: A vital component for companies producing generic versions of eslicarbazepine acetate-based medications.
• Metabolite Studies: Utilized in pharmacokinetic and metabolic pathway research related to oxcarbazepine therapy.

Basic Information

Product Name	Eslicarbazepine
CAS No.	104746-04-5
Molecular Formula	C15H12N2O2
Molecular Weight	252.27 g/mol
Synonyms	(S)-Licarbazepine; (10S)-10,11-Dihydro-10-hydroxy-5H-dibenzo[b,f]azepine-5-carboxamide; BIA 2-005; S-Licarbazepine; Eslicarbazepine (free base); (S)-Oxcarbazepine metabolite; ESLI
EINECS	Contact for details

Quality Control

Our Eslicarbazepine is manufactured under strict quality management systems. Each batch is tested to ensure compliance with ICH guidelines and relevant pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing specifications for identity, purity, related substances, residual solvents, and other critical parameters. We support regulatory filings with full traceability and documentation.

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 prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 99.0%
Related Substances (HPLC)	Total impurities ≤ 0.5% Any individual impurity ≤ 0.1%
Optical Rotation	[α]20/D: Specific range provided on COA
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 10 ppm
Loss on Drying	≤ 0.5%
Sulfated Ash	≤ 0.1%

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