ZOPICLONE

Zopiclone API is a non-benzodiazepine hypnotic agent widely used for the short-term treatment of insomnia. It effectively reduces sleep latency, improves sleep duration, and enhances sleep quality without significantly altering sleep architecture.

At Bluepill Express, we are a WHO-GMP, ISO 9001:2015, and cGMP-certified manufacturer and exporter of Zopiclone Active Pharmaceutical Ingredient (API). Our API complies with USP, BP, IP, and EP pharmacopeial standards, ensuring high purity, consistent particle size, and low impurity content, ideal for oral tablet and capsule formulations.

Zopiclone acts as a GABA-A receptor modulator, enhancing GABAergic neurotransmission, which promotes sedation and sleep induction. It is widely used in oral tablets and is suitable for combination therapy with other supportive agents in insomnia management.

Therapeutic Applications:

• Short-term insomnia treatment
• Difficulty in falling asleep (sleep latency reduction)
• Improvement of sleep duration and quality
• Sleep disturbances due to stress or medical conditions
• Combination therapy for patients requiring hypnotic support

Mechanism of Action:

Zopiclone binds selectively to benzodiazepine receptors at the GABA-A receptor complex, increasing chloride ion channel activity, resulting in neuronal hyperpolarization. This enhances the inhibitory effect of GABA, producing sedative and hypnotic effects without strong anxiolytic or muscle-relaxant properties.

Technical Specifications:

• Chemical Name: (RS)-6-(5-chloro-2-pyridyl)-6,7-dihydro-7-oxo-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate
• Molecular Formula: C₁₇H₁₈ClN₅O₃
• Molecular Weight: 388.82 g/mol
• CAS Number: 43200-80-2
• Description: White to off-white crystalline powder
• Assay (on dried basis): NLT 98.0% and NMT 102.0%
• Melting Point: 173°C – 175°C
• Solubility: Slightly soluble in water; freely soluble in ethanol and methanol
• Storage Conditions: Store in a tightly closed container, below 30°C, protected from light and moisture

Pharmacological Classification:

• Therapeutic Class: Non-Benzodiazepine Hypnotic / Sedative
• Pharmacopoeial Standards: IP / BP / USP / EP
• Dosage Form Applications:
  • Tablets (3.75 mg, 5 mg, 7.5 mg)
  • Capsules
  • Combination formulations for insomnia

Quality & Manufacturing – Bluepill Express Standards:

• Produced in WHO-GMP, ISO, and cGMP-certified facilities
• High assay purity (≥99%) and low impurity levels
• Verified using HPLC, IR, and UV spectroscopy
• Batch-to-batch consistency and stability
• Compliance with USP/BP/IP pharmacopeial standards
• COA, MSDS, and DMF available for regulatory and export requirements

Advantages of Bluepill Express Zopiclone API:

• High purity and crystalline quality for optimal tablet formulation
• Regulatory-ready API suitable for global export
• Consistent particle size and flow properties for tableting
• Reliable bulk supply with flexible packaging
• Long shelf-life under recommended storage conditions

Packaging & Export Details:

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