Phenobarbital Sodium
A premium barbiturate anticonvulsant and sedative-hypnotic, acting powerfully by enhancing GABAergic inhibition in the central nervous system.
CAS Number
57-30-7
Formula
C₁₂H₁₁N₂NaO₃
Mol. Weight
254.22 g/mol
Grade
BP / EP / USP
Product Overview
Phenobarbital Sodium is the highly soluble sodium salt of phenobarbital, a long-acting barbiturate with anticonvulsant, sedative, and hypnotic properties. It profoundly enhances GABA-mediated inhibition in the neuronal framework, rendering it highly effective for controlling a wide pathological spectrum of seizures. As one of the most widely used antiepileptic drugs worldwide, it is particularly effective in treating tonic-clonic, partial, and neonatal seizures.
As a trusted pharmaceutical market leader, Jay Overseas specializes in sourcing and distributing high-quality APIs like Phenobarbital Sodium to formulators and distributors worldwide. We maintain strategic partnerships with WHO-GMP certified facilities to ensure optimal performance.
Controlled Substance Mgmt
Fully licensed management and facilitation of import/export narcotic clearances.
High Solubility
Highly soluble sodium salt making it exceptionally suitable for parenteral formulations.
API Snapshot
Mechanism of Action
GABA Enhancement
Phenobarbital Sodium enhances the activity of gamma-aminobutyric acid (GABA), the primary inhibitory neurotransmitter in the CNS.
Channel Opening
It binds to GABA-A receptors and prolongs the opening of chloride channels, increasing neuronal inhibition and raising the seizure threshold.
Excitability Reduction
At higher concentrations, it also directly activates chloride channels and inhibits excitatory glutamate receptors, contributing to its anticonvulsant and sedative effects.
Therapeutic Applications
Generalized Seizures
Treatment of generalized tonic-clonic (grand mal) seizures.
Partial Seizures
Management of partial (focal) seizures providing steady-state neuro-inhibition.
Status Epilepticus
Emergency treatment of status epilepticus using the highly soluble IV formulation.
Pediatric Interventions
Indicated for neonatal seizures and severe febrile seizures in children.
Clinical Advantages & Value Proposition
With its proven stability and highly soluble pharmacokinetic profile, Phenobarbital Sodium ensures robust neurological delivery.
Long half-life (48-120 hours) allows once or twice daily dosing
Cost-effective anticonvulsant therapy designated as a WHO Essential Medicine
Available in multiple formulations: oral tablets, elixir, and injection
Well-established safety profile with decades of proven clinical use
Highly soluble sodium salt variant making it exceptionally suitable for parenteral administration
Broad spectrum anticonvulsant activity effective across various seizure types
Manufacturing Excellence
Our Phenobarbital Sodium API is manufactured in state-of-the-art WHO-GMP certified facilities applying robust continuous process controls. As a controlled substance, we enforce stringent compliance with global narcotic and psychotropic conventions to guarantee seamless supply logistics 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, crystalline powder or colorless crystals |
| 2 | Solubility | Freely soluble in water, soluble in alcohol, practically insoluble in ether |
| 3 | Identification | IR spectrum conforms to ref. standard; Positive test for sodium; Positive reaction for barbiturates |
| 4 | pH (2% aqueous solution) | 9.2 – 10.5 |
| 5 | Loss on Drying | Not more than 3.0% (105°C, 3 hours) |
| 6 | Related Substances (HPLC) | N-Methylphenobarbital: NMT 0.5%, 5-Ethyl-5-phenylhydantoin: NMT 0.3%, Individual impurity: NMT 0.2%, Total: NMT 1.5% |
| 7 | Residue on Ignition | Not more than 0.1% |
| 8 | Heavy Metals | NMT 10 ppm |
| 9 | Residual Solvents | Complies with ICH Q3C guidelines (Class 2 & 3 solvents) |
| 10 | Clarity of Solution | Solution in water is clear and colorless |
| 11 | Assay (Titrimetry, dried) | 99.0% – 101.0% (calculated as C₁₂H₁₁N₂NaO₃) |
| 12 | Microbial Limits | TAMC: NMT 1000 CFU/g, TYMC: NMT 100 CFU/g, E. coli & Salmonella: Absent |
| 13 | Bacterial Endotoxins | Less than 0.83 EU/mg (for injectable grade) |
Why Choose Our Phenobarbital Sodium 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.
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Legal Disclaimer: Phenobarbital Sodium is a highly regulated controlled 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.