Active Pharmaceutical Ingredient

Phenytoin — CAS 57-41-0

Also known as: Diphenylhydantoin; Dilantin (brand); Fosphenytoin precursor

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

Product Overview

Phenytoin is a widely used antiepileptic drug that stabilizes neuronal membranes by reducing sodium ion influx. Mediocon Inc manufactures this high-purity API at its GMP-certified facility in Aurangabad, Maharashtra, India. It is used to control tonic-clonic seizures and focal seizures, and is also used in the treatment of trigeminal neuralgia.

Therapeutic Applications
  • Control of tonic-clonic (grand mal) seizures
  • Prevention and treatment of focal (partial) seizures
  • Management of status epilepticus (IV formulations)
  • Treatment of trigeminal neuralgia in select cases

Technical Specifications

ParameterSpecification
CAS Number57-41-0
Molecular FormulaC15H12N2O2
Molecular Weight252.27 g/mol
GradeIP / BP / EP / USP
CategoryAnticonvulsant / Antiepileptic
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoPHY/24032026
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 / EP / 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
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