Description

Rufinamide CAS NO 106308-44-5 is a triazole derivative antiepileptic drug, specifically a sodium channel blocker. This high-purity active pharmaceutical ingredient (API) is critical for the formulation of effective and reliable seizure control medications. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of treatments for Lennox-Gastaut syndrome and other refractory epilepsies.

Application

• Primary Active Pharmaceutical Ingredient (API) in the manufacture of antiepileptic drugs.
• Formulation of oral tablets and suspensions for the treatment of seizures associated with Lennox-Gastaut syndrome.
• Use in clinical research and development of new therapeutic agents for refractory epilepsy.
• Reference standard in analytical laboratories for quality control and method validation.
• Intermediate in the synthesis of more complex pharmaceutical compounds within neurological drug discovery.
• Component in non-clinical studies investigating mechanisms of sodium channel modulation.

Basic Information

Product Name	Rufinamide
CAS No.	106308-44-5
Molecular Formula	C10H8F2N4O
Molecular Weight	238.20 g/mol
Synonyms	1-[(2,6-Difluorophenyl)methyl]-1H-1,2,3-triazole-4-carboxamide; CGP 33101; E 2080; Fycompa (Note: Fycompa is Rufinamide's brand/trade name); Banzel (US brand name); Inovelon (EU brand name); Xilep; Triazolecarboxamide derivative.
EINECS	Contact for details

Quality Control

Our Rufinamide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent pharmacopeial standards, including identification, purity, assay, and impurity profile. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with relevant specifications for pharmaceutical use.

Storage

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

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.15% Total impurities: ≤ 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.