Description

Fosphenytoin Sodium is a water-soluble phosphate ester prodrug of phenytoin, designed for rapid and efficient administration. This compound is critical for providing a safer and more reliable alternative to intravenous phenytoin in emergency and clinical settings. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of injectable anticonvulsant medications for the treatment of status epilepticus and the prevention of seizures during neurosurgery.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active component in injectable formulations for the control of convulsive seizures.
• Hospital Emergency Medicine: Formulated into ready-to-use intravenous (IV) or intramuscular (IM) injections for the acute treatment of status epilepticus.
• Neurosurgical Prophylaxis: Used in pre- and post-operative care to prevent or manage seizures related to brain surgery or head trauma.
• Generic Drug Manufacturing: Serves as a key starting material for companies producing generic versions of branded anticonvulsant injectables.
• Clinical Research: Employed in preclinical and clinical studies investigating new delivery methods or expanded therapeutic indications for phenytoin prodrugs.
• Drug Delivery System Development: Studied for potential use in advanced parenteral delivery systems due to its improved solubility profile over phenytoin.

Basic Information

Product Name	Fosphenytoin Sodium
CAS No.	92134-98-0
Molecular Formula	C16H15N2Na2O6P
Molecular Weight	416.25 g/mol
Synonyms	Fosphenytoin Disodium; Phenytoin Prodrug; ACC-9653; Cerebyx (Brand Name Reference); 5,5-Diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione Disodium Salt; Phosphoryloxymethyl Phenytoin Disodium; Phenyltoin Phosphate Ester Disodium Salt
EINECS	Contact for details

Quality Control

Our Fosphenytoin Sodium is manufactured and tested under strict quality systems suitable for pharmaceutical applications. We provide material that can meet relevant pharmacopeial standards (e.g., USP, EP) for identity, purity, and strength. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters to ensure supply reliability and regulatory compliance for our global partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and degradation.

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% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Related Substances (HPLC)	Total impurities ≤ 1.0%; Individual unknown impurity ≤ 0.2%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	< 0.2 EU/mg (for injectable grade)
Sterility	Sterile (for finished sterile API grade)

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