Description

Phenytoin Sodium is the sodium salt form of the widely used anticonvulsant drug phenytoin. This compound is a critical active pharmaceutical ingredient (API) essential for the formulation of anti-epileptic medications. It is primarily utilized by pharmaceutical manufacturers and research institutions in the development and production of injectable and oral dosage forms. The product is supplied as a high-purity material to meet stringent pharmacopeial standards for global pharmaceutical applications.

Application

• Pharmaceutical API: Primary use as the active ingredient in anti-epileptic and anti-seizure medications.
• Injectable Formulations: Manufacture of sterile injectable solutions for hospital and emergency use.
• Oral Solid Dosage Forms: Production of capsules and tablets for chronic management of epilepsy.
• Neurological Research: Used as a reference standard and experimental compound in neuroscience and pharmacology research.
• Generic Drug Manufacturing: Sourcing for the production of bioequivalent generic pharmaceutical products.
• Veterinary Medicine: Application in veterinary pharmaceuticals for the control of seizures in animals.

Basic Information

Product Name	Phenytoin Sodium
CAS No.	630-93-3
Molecular Formula	C15H11N2NaO2
Molecular Weight	274.25 g/mol
Synonyms	5,5-Diphenylhydantoin Sodium Salt; Sodium Phenytoin; Diphenylhydantoin Sodium; Phenytoin Sodium Salt; Soluble Phenytoin; Epanutin Sodium (Trade Name); Dilantin Sodium (Trade Name); Antisacer
EINECS	211-148-2

Quality Control

Our Phenytoin Sodium is manufactured and tested to meet or exceed the stringent requirements of major international pharmacopeias, including USP, EP, and BP monographs. Every batch undergoes comprehensive analytical testing for identity, purity, and potency. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting compliance with all specified parameters. Our quality management system is designed to ensure batch-to-batch consistency and traceability for pharmaceutical customers.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (Sodium)	Conforms to standard
Assay (HPLC)	98.5% - 101.5% (on anhydrous basis)
Water (KF)	≤ 2.0%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Residual Solvents	Complies with ICH Q3C guidelines
pH (5% Solution)	10.0 - 12.0
Clarity & Color of Solution	Clear, colorless to slightly yellow

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