Phenytoin API
A premium hydantoin-derivative anticonvulsant structurally engineered to stabilize neuronal membranes and effectively treat diverse seizure disorders.
CAS Number
57-41-0
Formula
C₁₅H₁₂N₂O₂
Mol. Weight
252.27 g/mol
Grade
BP / EP / USP
Product Overview
Phenytoin is a highly effective, legacy hydantoin-derivative anticonvulsant heavily relied upon in global epilepsy treatment protocols. By profoundly stabilizing neuronal membranes and regulating sodium channel mechanics, it controls extreme neuronal excitability, making it the bedrock therapeutic standard for resolving both complex partial and tonic-clonic seizures.
As a global pharmaceutical leader, Jay Overseas guarantees reliable sourcing of this essential API. We distribute Phenytoin derived purely from state-of-the-art WHO-GMP certified facilities with complete regulatory profiles, extending our reliable supply chain network into the most demanding regulatory markets.
Crystalline Integrity
Consistently controlled particle morphology yielding robust API compaction.
Formulation Agnostic
Easily adaptable into solid oral systems or stable suspension mediums.
API Snapshot
Mechanism of Action
Membrane Stabilization
Phenytoin physically stabilizes neuronal membranes by modulating voltage-gated sodium channels.
Inactive State Prolongation
It significantly prolongs the inactive state of these sodium channels, throttling the ability of specific neurons to fire repetitively at high frequency.
Action Potential Inhibition
This targeted blocking halts the erratic spread of seizure activity and decisively prevents the propagation of abnormal electrical discharges throughout the brain.
Therapeutic Applications
Generalized Seizures
Primary treatment vector for generalized tonic-clonic (grand mal) seizures.
Partial Seizures
Effective management of complex partial seizures providing steady neuro-inhibition.
Status Epilepticus
Emergency therapeutic alternative in injectable form for profound status epilepticus.
Neurological Prophylaxis
Prevention and treatment of seizures following severe head trauma or neurosurgery.
Clinical Advantages & Value Proposition
Phenytoin provides unparalleled seizure suppression via sodium channel modulation across multiple established treatment protocols.
Long half-life (average 22 hours) allows convenient once or twice daily dosing
Highly cost-effective anticonvulsant therapy option globally
Available and stable in multiple formulation forms (tablets, capsules, suspension, injection)
Extensive clinical experience spanning decades with predictable pharmacokinetic profiling
Non-sedating at properly maintained therapeutic doses
Broadly effective for multiple seizure types including tonic-clonic and focal seizures
Manufacturing Excellence
Our Phenytoin API is manufactured in state-of-the-art WHO-GMP certified facilities applying robust continuous process controls. Our compliance framework aligns universally with global pharmacopoeial standards, guaranteeing an unbroken supply line with uncompromising precision for our B2B partners.
Export Status
45+ Countries (Globally)
Documentation
Complete Technical Pack
Detailed Specifications
Rigidly Compliant with Standard Pharmacopoeia (USP / EP / BP)
| Sr. | Test Parameter | Global Specification Validation |
|---|---|---|
| 1 | Description | White or almost white, crystalline powder |
| 2 | Solubility | Practically insoluble in water, soluble in hot alcohol, soluble in dilute alkali |
| 3 | Identification | IR spectrum conforms; Melting point 295-298°C; Positive color reaction for hydantoins |
| 4 | Melting Point | 295°C – 298°C |
| 5 | Loss on Drying | Not more than 0.5% (105°C, 3 hours) |
| 6 | Related Substances (HPLC) | 5,5-Diphenylhydantoin: NMT 0.3%, Benzophenone: NMT 0.2%, Individual impurity: NMT 0.10%, Total: NMT 1.0% |
| 7 | Residue on Ignition | Not more than 0.1% |
| 8 | Heavy Metals | NMT 20 ppm |
| 9 | Residual Solvents | Complies with ICH Q3C guidelines (Class 2 & 3 solvents) |
| 10 | Chloride | NMT 200 ppm |
| 11 | Assay (Titrimetry, dried) | 99.0% – 101.0% (calculated as C₁₅H₁₂N₂O₂) |
| 12 | Microbial Limits | TAMC: NMT 1000 CFU/g, TYMC: NMT 100 CFU/g, E. coli & Salmonella: Absent |
| 13 | Particle Size Distribution | As per customer requirement |
Why Choose Our Phenytoin API
Regulatory Excellence
Products sourced from facilities with USFDA DMF filed, WHO-GMP certified, with full compliance to BP, EP, and USP standards.
Pharmaceutical Grade Quality
Consistent high-purity API with stringent impurity control and complete analytical documentation for each batch.
Reliable Global Supply
Consistent availability with efficient logistics to 45+ countries, backed by our extensive pharmaceutical trading network.
Complete Documentation
Full technical packages available including DMF access, multi-zone stability data, and detailed Certificate of Analysis (CoA).
Related CNS APIs
Packaging Standard
Double LDPE/HDPE inner bags secured inside robust fiber drums with inner liner. Available in 5 kg, 10 kg, and 25 kg pack sizes. Custom packing available.
Storage Protocol
Store at controlled room temperature 15–30°C (59–86°F). Must be protected from light and moisture and kept securely tightly closed.
Validated Shelf Life
Comprehensive stability data confirms an extended shelf life of 36-60 months when stored strictly under the recommended ambient conditions.
Ready to Source Top-Tier API?
Contact our technical and commercial team for prompt dispatch of samples, competitive pricing, and full regulatory document support.
Legal Disclaimer: Phenytoin is a highly regulated therapeutic substance in most global jurisdictions. The product documentation, CoAs, and regulatory support detailed above are exclusively available for licensed pharmaceutical manufacturing entities and authorized research divisions under proper legal importation compliances. This API is not a finished dosage form.