NITRAZEPAM

Nitrazepam API is a potent benzodiazepine derivative widely used in the treatment of insomnia, anxiety disorders, and epilepsy. It acts as a central nervous system (CNS) depressant, producing sedative, hypnotic, anxiolytic, and anticonvulsant effects.

At Bluepill Express, we are a certified manufacturer and exporter of Nitrazepam Active Pharmaceutical Ingredient (API), adhering to WHO-GMP, ISO 9001:2015, and cGMP guidelines. Our Nitrazepam API complies with IP / BP / USP standards and is produced with strict quality control, ensuring exceptional purity, uniform particle size, and consistent potency for various pharmaceutical formulations.

Nitrazepam works by enhancing the inhibitory neurotransmitter GABA (gamma-aminobutyric acid) in the brain, resulting in decreased neural activity and a calming effect on the central nervous system. It is commonly used for short-term management of insomnia, treatment of anxiety disorders, and adjunct therapy in epilepsy.

Bluepill Express supplies Nitrazepam API globally, backed by full regulatory documentation, ensuring reliability, quality, and compliance with international pharmaceutical standards.

Therapeutic Applications:

• Insomnia (short-term management)
• Anxiety and stress-related disorders
• Adjunctive therapy for epilepsy (especially myoclonic and tonic-clonic seizures)
• Sedation prior to minor surgical or diagnostic procedures

Mechanism of Action:

Nitrazepam binds to the benzodiazepine receptor on the GABA-A receptor complex, enhancing the effect of GABA. This action increases the frequency of chloride channel opening, leading to neuronal hyperpolarization and inhibition of nerve transmission, resulting in sedation, muscle relaxation, and anticonvulsant effects.

Technical Specifications:

• Chemical Name: 7-Nitro-5-phenyl-1,3-dihydro-1,4-benzodiazepin-2-one
• Molecular Formula: C₁₅H₁₁N₃O₃
• Molecular Weight: 281.27 g/mol
• CAS Number: 146-22-5
• Description: White to pale yellow crystalline powder
• Assay (on dried basis): NLT 98.0% and NMT 102.0%
• Solubility: Practically insoluble in water, freely soluble in acetone and chloroform
• Melting Point: 225°C – 230°C
• Storage Conditions: Store below 25°C in a well-closed, light-resistant container

Pharmacological Classification:

• Therapeutic Class: Hypnotic, Sedative, Antiepileptic (Benzodiazepine Class)
• Pharmacopoeial Standards: IP / BP / USP
• Dosage Form Applications:
  • Tablets (5 mg, 10 mg)
  • Capsules
  • Oral solutions
  • Combination formulations for CNS disorders

Quality & Manufacturing – Bluepill Express Standards:

• Produced in WHO-GMP and ISO-certified facilities
• High assay purity (≥99%) and low impurity content
• Verified by HPLC, IR, and UV spectrophotometric methods
• Complies with USP / BP / IP monographs
• Full regulatory documentation: COA, MSDS, and DMF (available on request)
• Manufactured under controlled environmental and temperature conditions

Advantages of Bluepill Express Nitrazepam API:

• High stability and consistent potency suitable for solid and liquid formulations
• Pharma-grade crystalline structure ensuring predictable bioavailability
• Global export quality compliant with WHO-GMP, ISO, and regulatory norms
• Ready documentation for international registration and formulation support
• Bulk supply capacity with flexible packaging and timely dispatch

Packaging & Export Details:

• Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with inner LDPE liner
• Labeling: As per international pharmacopeial and regulatory standards
• Shelf Life: 3 years (under recommended storage conditions)
• Export Markets: Africa, Asia-Pacific, Middle East, Latin America, Europe
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Drug Master File (DMF) – on request
  • Non-GMO & BSE/TSE certificates