Active Pharmaceutical Ingredient

Phenytoin Sodium — CAS 57-41-0

Also known as: Diphenylhydantoin Sodium; Soluble Phenytoin; Dilantin Sodium

GMP Certified IP / BP / USP Anticonvulsant / Antiepileptic Aurangabad, India
Phenytoin Sodium API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Phenytoin Sodium IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 57-41-0

Product Overview

Phenytoin Sodium is a sodium salt form of phenytoin, a widely used antiepileptic drug. Manufactured by Mediocon Inc at its GMP-certified facility in Aurangabad, Maharashtra, India, it is supplied as IP/BP/USP grade for injectable and oral pharmaceutical formulations worldwide. CAS No: 57-41-0.

Therapeutic Applications
  • Treatment and prevention of tonic-clonic and partial seizures
  • Intravenous use for status epilepticus management
  • Prophylaxis in neurosurgical patients
  • Treatment of trigeminal neuralgia and cardiac arrhythmias

Technical Specifications

ParameterSpecification
CAS Number57-41-0
Molecular FormulaC15H11N2NaO2
Molecular Weight278.25 g/mol
GradeIP / BP / USP
CategoryAnticonvulsant / Antiepileptic
AppearanceWhite or almost white crystalline powder
SolubilityFreely soluble in water, practically insoluble in ethanol.
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
💬
Mediocon AI
Hello 👋 How can I help you today?