Diazepam Powder: Pharmaceutical Profile, Clinical Applications, and Regulatory Overview
Introduction
Diazepam (CAS No. 439-14-5), a member of the benzodiazepine class, is a widely recognized anxiolytic, anticonvulsant, muscle relaxant, and sedative agent. First synthesized in 1959 by Hoffmann-La Roche, diazepam has remained a cornerstone in clinical medicine due to its rapid onset, predictable pharmacokinetics, and broad therapeutic applications.
Although diazepam powder is a controlled substance, it is legally used in licensed pharmaceutical manufacturing and research laboratories for formulation studies, analytical calibration, and pharmacological research.
Informational: Chemical Identity and Properties
| Property | Details |
|---|---|
| Chemical Name | 7-chloro-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one |
| Common Names | Diazepam, Valium, Seduxen, Diastat |
| Chemical Formula | C₁₆H₁₃ClN₂O |
| Molecular Weight | 284.7 g/mol |
| CAS Number | 439-14-5 |
| IUPAC Name | 7-chloro-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one |
| Chemical Class | Benzodiazepine derivative |
| Appearance | White to off-white crystalline powder |
| Melting Point | 131–133 °C |
| Solubility | Slightly soluble in water; soluble in ethanol, chloroform, and acetone |
| Storage Conditions | Store in airtight containers, protected from light and moisture |
Mechanism of Action
Diazepam enhances the activity of gamma-aminobutyric acid (GABA), the primary inhibitory neurotransmitter in the CNS. By binding to the GABA-A receptor complex, diazepam increases chloride ion influx, hyperpolarizing neurons and producing sedative, anxiolytic, anticonvulsant, and muscle-relaxing effects.
Navigational: Clinical and Research Applications
Diazepam remains extensively used in both clinical settings and pharmacological research.
Clinical Uses
| Indication | Role of Diazepam | Dosage Form |
|---|---|---|
| Anxiety disorders | Short-term relief of generalized anxiety | Tablets, oral solution |
| Muscle spasms | Skeletal muscle relaxant | Tablets, injectable |
| Seizure management | Status epilepticus emergency treatment | Injectable (IV/IM) |
| Sedation | Preoperative and procedural sedation | IV solution |
| Alcohol withdrawal | Reduces agitation and risk of seizures | Oral or injectable forms |
Research and Laboratory Use
Licensed laboratories may handle diazepam powder as:
- Analytical reference material for HPLC, LC-MS/MS, or GC-MS calibration
- API for formulation development in pharmaceutical R&D
- Pharmacokinetic and receptor-binding studies
- Educational tools for teaching medicinal chemistry or drug regulation
Commercial: Legal and Licensed Supply
While diazepam powder is controlled, authorized supply exists for pharmaceutical and research purposes.
| Supplier Type | Regulatory Requirement | Permitted Use |
|---|---|---|
| Licensed pharmaceutical manufacturers | DEA Schedule IV license (US), equivalent in other countries | Tablet, injectable, and formulation production |
| ISO 17034-certified reference material suppliers | Laboratory license for controlled substances | Analytical calibration and quality control |
| Academic research institutions | Institutional ethics and controlled substance permit | Receptor and pharmacokinetic studies |
| Compounding pharmacies | Regulatory compliance with GMP/GDP | Formulation of patient-specific dosage forms |
⚠️ All transactions are strictly regulated, requiring chain-of-custody documentation, import/export permits, and CoA verification.
Safety Profile and Handling
Diazepam exhibits dose-dependent CNS depression and anticholinergic effects at high concentrations. Proper handling in laboratories ensures both research integrity and personnel safety.
| Hazard Classification (GHS) | Symbol | Precautionary Measures |
|---|---|---|
| Acute Toxicity (Oral, Dermal) | ⚠️ | Avoid direct contact; use PPE |
| Eye Irritation | ⚠️ | Safety goggles required |
| CNS Depressant | ⚠️ | Avoid inhalation or accidental ingestion |
| Environmental Hazard | ☣️ | Dispose as hazardous pharmaceutical waste |
Laboratory Best Practices:
- Use in a fume hood or well-ventilated area
- Wear gloves, lab coat, and goggles
- Store below 25 °C, dry, and protected from light
- Dispose via approved pharmaceutical waste management systems
Transactional: Legal and Regulatory Framework
Diazepam is a Schedule IV controlled substance in the U.S. and similarly regulated internationally.
| Region / Country | Legal Status | Regulatory Agency |
|---|---|---|
| United States | Schedule IV (controlled substance) | DEA |
| European Union | Prescription-only benzodiazepine | EMA / National authorities |
| Canada | Schedule IV controlled drug | Health Canada |
| United Kingdom | Class C (Misuse of Drugs Act) | Home Office |
| Australia | Schedule 4 Prescription-Only Medicine | TGA |
| India | Schedule H prescription drug | CDSCO |
Key Takeaway: Unlicensed possession or sale is illegal. However, licensed laboratories, hospitals, and pharmacies can legally handle diazepam powder for formulation, research, or educational purposes.
Comparative Table: Diazepam vs Other Benzodiazepines
| Benzodiazepine | Half-Life | Potency | Primary Use | Sedation Risk |
|---|---|---|---|---|
| Diazepam | 30–60 h | Moderate | Anxiety, seizures, sedation | Moderate |
| Lorazepam | 12–18 h | High | Acute anxiety, seizure | Low-moderate |
| Alprazolam | 11–16 h | High | Panic disorder, anxiety | Low-moderate |
| Clonazepam | 18–50 h | High | Seizures, panic | Moderate |
This helps researchers, clinicians, and formulators understand pharmacokinetic differences and therapeutic applications.
Research and Development Insights
Diazepam powder is used in research to:
- Evaluate GABAergic modulation in CNS disorders
- Develop new benzodiazepine derivatives with reduced sedation
- Study drug–drug interactions and metabolic pathways
- Serve as reference standard in toxicology and forensic labs
These applications support evidence-based medicine, drug safety monitoring, and regulatory compliance.
Conclusion
Diazepam powder remains a cornerstone benzodiazepine for both clinical use and pharmaceutical research. Its established safety profile, versatile pharmacological actions, and regulatory recognition make it indispensable for licensed laboratories, educational institutions, and pharmaceutical manufacturers.
By adhering to strict legal and safety protocols, researchers can utilize diazepam powder for formulation development, analytical calibration, and scientific study, contributing to ongoing advancements in CNS therapeutics and pharmacology.
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- Prescription Required: Yes, Diazepam should only be used under the guidance of a healthcare provider. Dosage varies based on individual needs, medical conditions, and treatment goals.
- Forms: It is available in oral, injectable, and topical forms. In powder form, it is typically used in research settings and should not be consumed without medical supervision.
Side Effects:
- Common: Drowsiness, dizziness, poor coordination, and gastrointestinal issues.
- Serious: Risk of addiction, overdose, and withdrawal symptoms if used long-term or abruptly stopped. Rarely, severe side effects include respiratory issues, suicidal thoughts, and agitation.
Legal and Safety Information:
- Regulation: Diazepam is a controlled substance and requires a prescription. It is classified as a Schedule IV drug under the Controlled Substances Act in the U.S.
- Warnings: Not recommended during pregnancy or breastfeeding. Avoid use if you have a history of substance abuse, severe liver disease, or respiratory issues.
Where to Buy Diazepam Powder:
- Reputable Suppliers: Purchase from verified pharmaceutical suppliers or licensed online pharmacies. Ensure that the supplier provides proper certifications and adheres to quality standards.
- Direct Supply: Look for suppliers with a direct supply network to ensure the authenticity and quality of the product.
- Online Purchase: Be cautious of deals that seem too good to be true. Verify the supplier’s contact information and reviews before making a purchase.
Product Details:
- Purity: >99.5%
- Production Capacity: Approximately 500 kg per month
- Packaging: Typically in aluminum foil bags or plastic bags
- Storage: Store in a cool, dry place.
Shipping and Delivery:
- Delivery Time: Typically 4-7 days depending on the shipping method (e.g., UPS, EMS, DHL, FedEx).
- Customs: Be aware of strict customs regulations in certain countries. Suppliers often ensure 100% delivery but check the return policy for lost or undelivered items.
Important Note: Diazepam powder is often used in research and should not be used without medical supervision or for non-research purposes.
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