PHENOBARBITAL

Phenobarbital API is a long-acting barbiturate widely used as an anticonvulsant and sedative. It is highly effective in controlling generalized and partial seizures, and it is often prescribed for epilepsy management, neonatal seizures, and sometimes for short-term sedation in medical procedures.

At Bluepill Express, we manufacture and export Phenobarbital Active Pharmaceutical Ingredient (API) under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities. Our Phenobarbital API complies with USP, BP, IP, and EP standards, ensuring high purity, consistent particle size, and low impurity content, making it ideal for oral and injectable formulations.

Phenobarbital works by enhancing the activity of gamma-aminobutyric acid (GABA) in the central nervous system, increasing neuronal inhibition and reducing seizure frequency. Its long half-life allows for once-daily dosing in many epilepsy treatment plans, providing convenience and effective seizure control.

Therapeutic Applications:

• Epilepsy (tonic-clonic, partial, and myoclonic seizures)
• Neonatal seizures
• Sedation for preoperative or minor procedures
• Adjunct therapy in status epilepticus
• Anxiolytic and hypnotic uses (short-term)

Mechanism of Action:

Phenobarbital enhances the GABAergic neurotransmission by binding to the GABA-A receptor, prolonging the opening of chloride ion channels. This results in hyperpolarization of neurons, reducing excitability and preventing the spread of seizure activity across the central nervous system.

Technical Specifications:

• Chemical Name: 5-Ethyl-5-phenyl-1,3-diazinane-2,4,6-trione
• Molecular Formula: C₁₂H₁₂N₂O₃
• Molecular Weight: 232.24 g/mol
• CAS Number: 50-06-6
• Description: White to pale yellow crystalline powder
• Assay (on dried basis): NLT 98.0% and NMT 102.0%
• Melting Point: 174°C – 175°C
• Solubility: Slightly soluble in water, freely soluble in ethanol and chloroform
• Storage Conditions: Store in a tightly closed container, below 30°C, protected from light and moisture

Pharmacological Classification:

• Therapeutic Class: Anticonvulsant / Sedative (Barbiturate Class)
• Pharmacopoeial Standards: USP / BP / IP / EP
• Dosage Form Applications:
  • Tablets (30 mg, 60 mg, 100 mg)
  • Oral solutions
  • Injectable formulations
  • Combination antiepileptic drug formulations

Quality & Manufacturing – Bluepill Express Standards:

• Manufactured in WHO-GMP, ISO, and cGMP-certified facilities
• High assay purity (≥99%) with minimal impurities
• HPLC and UV spectroscopic testing for identity and consistency
• Batch-to-batch reproducibility and long-term stability
• Full documentation: COA, MSDS, and DMF available
• Controlled environment production to ensure pharma-grade quality

Advantages of Bluepill Express Phenobarbital API:

• Consistent high purity and crystalline quality suitable for solid and injectable formulations
• Global regulatory compliance for export to multiple markets
• Reliable bulk supply with flexible packaging options
• Support for DMF and international registration
• Long shelf-life and stability for extended storage

Packaging & Export Details:

• Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with LDPE liner
• Shelf Life: 3 years under recommended storage
• Labeling: In compliance with pharmacopeial and export regulations
• Export Markets: Africa, Asia-Pacific, Middle East, Europe, Latin America
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Drug Master File (DMF – on request)
  • Stability and impurity profile certificates