Phenobarbital API
A universally trusted, long-acting barbiturate structurally engineered for enduring anticonvulsant and sedative performance at enterprise reliability standards.
CAS Number
50-06-6
Formula
C₁₂H₁₂N₂O₃
Mol. Weight
232.24 g/mol
Grade
USP / EP / BP
Product Overview
Phenobarbital is a legacy barbiturate acting as a central nervous system depressant with potent anticonvulsant properties. It profoundly enhances GABA-mediated inhibition in the neuronal framework, rendering it highly effective for controlling a wide pathological spectrum of seizures. Used reliably for over a century, it remains one of the most widely employed antiepileptic APIs globally.
Particularly vital in broad economic settings due to its unmatched efficacy-to-cost ratio, Phenobarbital has secured a permanent position on the WHO Model List of Essential Medicines. We maintain strict compliance with global narcotic and psychotropic regulations, ensuring secure supply chain management worldwide.
Controlled Substance Mgmt
Fully licensed management and facilitation of import/export narcotic clearances.
Morphological Profile
Strictly controlled crystal habit for consistent downstream formulation.
API Snapshot
Mechanism of Action
Receptor Binding
Phenobarbital acts directly, binding to distinct allosteric sites on the GABA_A receptor complex in the central nervous system.
GABA Enhancement
It prolongs the duration of chloride channel opening, vastly enhancing the inhibitory effects of gamma-aminobutyric acid (GABA).
Excitability Reduction
The resulting profound hyperpolarization of the neuronal membrane limits nerve impulse transmission and reliably elevates the seizure threshold.
Therapeutic Applications
Generalized Seizures
Effective treatment regimen for generalized tonic-clonic seizures and complex partial episodes.
Neonatal & Febrile Seizures
Trusted therapeutic option for managing neonatal seizures and febrile seizures in pediatric populations.
Status Epilepticus
Utilized as a potent alternative or adjunctive therapy in prolonged status epilepticus.
Anxiety & Sedation
Acts as a broad CNS depressant for short-term sedation and anxiety management.
Clinical Advantages & Value Proposition
Phenobarbital combines profound clinical efficacy with universal accessibility, making it an irreplaceable API in neurological care globally.
WHO Essential Medicine designation assuring proven global efficacy and safety
Long half-life enabling convenient once or twice daily dosing regimens
Highly cost-effective treatment option ideal for diverse economic healthcare settings
Broad-spectrum anticonvulsant activity effective across various seizure types
Available and stable in multiple formulation forms (oral solid, liquid, injectable)
Well-established pharmacokinetic profile with predictable therapeutic monitoring
Manufacturing Excellence
Our Phenobarbital 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
50+ 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, odorless, crystalline powder or colorless crystals |
| 2 | Solubility | Slightly soluble in water, freely soluble in alcohol and ether |
| 3 | Identification | IR spectrum conforms to reference standard (EP) |
| 4 | Melting Point | 174°C – 178°C |
| 5 | pH (saturated solution) | 5.0 – 6.0 |
| 6 | Loss on Drying | Not more than 0.5% |
| 7 | Sulfated Ash | Not more than 0.1% |
| 8 | Related Substances (HPLC) | Phenobarbital N-oxide: NMT 0.5%, Any individual impurity: NMT 0.10%, Total impurities: NMT 1.0% |
| 9 | Heavy Metals | NMT 10 ppm |
| 10 | Residual Solvents | Complies with ICH Q3C guidelines |
| 11 | Assay (on dried basis) | 99.0% – 101.0% |
Why Choose Our Phenobarbital API
WHO Essential Medicine
Recognized globally with proven efficacy and comprehensive regulatory support for broad market access.
Regulatory Compliance
USFDA DMF filed with full compliance to major pharmacopeial standards including USP, EP, and BP.
High Purity API
Consistent manufacturing with stringent quality control ensuring high purity and an explicitly controlled impurity profile.
Global Supply Capability
Reliable supply chain distributing to 50+ countries with complete technical, documentation, and narcotic compliance support.
Related CNS APIs
Packaging Standard
Double LDPE inner bags secured inside robust HDPE or fiber drums. Available in standard 10 kg and 25 kg pack sizes. Custom packaging available.
Storage Protocol
Store at controlled room temperature 20–25°C (68–77°F). Must be protected from light and kept in tightly closed containers in a dry, ventilated area.
Validated Shelf Life
Comprehensive stability data confirms a standard shelf life of 36 months when stored strictly under the recommended ambient temperature conditions.
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Contact our technical and commercial team for prompt dispatch of samples, competitive pricing, regulatory documents, and narcotic license support.
Legal Disclaimer: Phenobarbital 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.