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Diazepam is a long-acting benzodiazepine widely used for the management of anxiety, muscle spasms, seizures, and alcohol withdrawal symptoms. It acts on the central nervous system (CNS) by enhancing the activity of gamma-aminobutyric acid (GABA), the primary inhibitory neurotransmitter, producing sedative, anxiolytic, muscle relaxant, and anticonvulsant effects.
Bluepill Express manufactures high-purity Diazepam API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring consistent quality, stability, and global pharmacopoeial compliance (IP, BP, USP, EP). Our API is suitable for tablet, capsule, and injectable formulations, providing reliable performance in CNS therapeutics.
Therapeutic Uses
- Anxiety disorders: Short-term relief of severe anxiety
- Muscle spasms: Management of skeletal muscle spasticity
- Seizure disorders: Adjunct therapy in epilepsy
- Alcohol withdrawal: Reduces withdrawal-related agitation and seizures
- Sedation: Preoperative sedation and calming for medical procedures
Mechanism of Action
Diazepam binds to the benzodiazepine site on the GABA-A receptor, enhancing the affinity of GABA for its receptor. This increases chloride ion influx, hyperpolarizing neurons and reducing excitability in the CNS, leading to anxiolytic, anticonvulsant, muscle relaxant, and sedative effects.
Pharmacological Information
- Chemical Name: 7-chloro-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one
- Molecular Formula: C16H13ClN2O
- Molecular Weight: 284.74 g/mol
- CAS Number: 439-14-5
- Therapeutic Class: Benzodiazepine
- Pharmacological Class: Anxiolytic / Anticonvulsant / Sedative
- ATC Code: N05BA01
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Freely soluble in ethanol and methanol; slightly soluble in water |
| Melting Point | 130°C – 132°C |
| pH (1% aqueous solution) | 5.5 – 7.0 |
| Storage | Store below 25°C in a dry, ventilated area, protected from light and moisture |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR, UV, and HPLC positive |
| Assay (Purity) | ≥ 99.0% (HPLC) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | ≤ 0.3% (individual impurity) |
| Bulk Density | 0.35 – 0.50 g/mL |
| Tapped Density | 0.50 – 0.65 g/mL |
Applications
Diazepam API is used in:
- Tablet and capsule formulations for anxiety and seizure management
- Injectable formulations for acute seizure control and preoperative sedation
- Muscle relaxant therapy
- Combination CNS therapy formulations
- Pharmaceutical bulk API for global export
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Method of Analysis (MOA)
- Stability Data (ICH-compliant)
- Regulatory Dossier / DMF (on request)
Packaging & Export Details
- Available Packs: 1 kg | 5 kg | 10 kg | 25 kg HDPE drums with double poly liners
- Labeling: Product name, batch number, manufacturing/expiry dates, storage instructions
- Shelf Life: 36 months under recommended storage conditions
- Export Markets: Africa, Asia, Latin America, Europe, Middle East
