Eszopiclone
Pharmaceutical Premium
Pharmaceutical API

Eszopiclone

High-purity pharmaceutical grade Eszopiclone manufactured to meet stringent USP/EP specifications for pharmaceutical formulations and research applications. Our pharmaceutical grade material delivers exceptional purity and consistency for critical pharmaceutical manufacturing.

  • USP/EP Grade Specifications
  • High Purity (≥99.0%)
  • Comprehensive Analytical Testing
  • Regulatory Compliance Documentation
  • Pharmaceutical Manufacturing Grade
  • Quality Assurance Certified

Technical Specifications

Chemical Formula: C17H17ClN6O3
CAS Number: 138729-47-2
Molecular Weight: 388.81 g/mol
Purity (HPLC): ≥99.0% (pharmaceutical grade)
Physical State: White to off-white crystalline powder
Water Content (Karl Fischer): ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% total impurities
Storage Conditions: Store in cool, dry place (15-25°C)
Packaging Options: 1kg, 5kg pharmaceutical containers

Applications

Sleep Disorder Drug Manufacturing
Insomnia Treatment Formulations
Hypnotic Agent Products
API Synthesis & Development
CNS Research Applications
Pharmaceutical Research
Drug Product Manufacturing
Quality Control Testing
Regulatory Compliance
Clinical Trial Materials
Bioanalytical Method Development
Reference Standard Applications

Industry-Specific Grades

DRAVYOM offers specialized Eszopiclone grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse sleep disorder and hypnotic drug manufacturing applications.

USP Grade (Pharmaceutical)
Purity: ≥99.0% (HPLC) Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: Pharmaceutical formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (pharmaceutical) Related Substances: ≤1.0% Residue on Ignition: ≤0.1% Application: European market compliance
Research Grade
Purity: ≥98.0% (analytical) Water Content: ≤1.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥99.5% (pharmaceutical) Endotoxins: ≤2.5 EU/mg Microbial Limits: Compliant Application: Sleep disorder formulations

Quality Standards

DRAVYOM's pharmaceutical grade Eszopiclone is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and ICH guidelines. Our pharmaceutical-grade production ensures consistent quality and regulatory compliance.

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥99.0% Pharmaceutical Purity
Advanced Analytical Testing
Ultra-Low Impurities
Batch-to-Batch Consistency
Traceable Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Eszopiclone exhibits exceptional chemical properties essential for sleep disorder therapy applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Slightly soluble
LogP (octanol/water): 0.59
pKa: 9.0
Molecular Weight: 388.81 g/mol
Physical Properties
Appearance: White to off-white crystalline powder
Melting Point: 162-165°C
Bulk Density: 0.5-0.7 g/mL
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
Bioavailability: 52-59% (oral)
Protein Binding: 52-59%
Half-life: 6 hours
Mechanism: GABA receptor modulator
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤0.5% total
Water Content: ≤0.5% (Karl Fischer)
Residue on Ignition: ≤0.1%
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Store below 25°C
pH Stability: Stable in neutral conditions

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Eszopiclone superiority in sleep disorder applications with exceptional GABA receptor modulation, sleep initiation efficacy, and reproducibility across diverse therapeutic protocols.

Sleep Initiation

Rapid sleep induction

Reduces sleep latency
Sleep Maintenance

Sustained sleep throughout the night

Improved sleep quality
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 3 years
Thermal Stability

Melting point: 162-165°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.1% between batches

Consistent therapeutic efficacy
GABA Modulation

Selective GABA receptor interaction

Minimal next-day residual effects

Safety Information

Controlled substance pharmaceutical ingredient requiring professional handling. Well-established safety profile for sleep disorder therapy. Handle with pharmaceutical-grade safety precautions and ensure proper GMP environmental controls. Clinical monitoring for dependency potential and complex sleep behaviors during therapeutic use.

Controlled Substance
Professional Use
Monitor for dependency

Storage & Handling

Store in original containers in a cool, dry, well-ventilated area away from moisture and light. Keep containers tightly closed and maintain pharmaceutical-grade environmental controls. Use appropriate GMP handling techniques for API processing.

Cool storage (15-25°C)
Protect from moisture (hygroscopic)
Protect from light
GMP handling required

Chemical Mechanisms & Reaction Pathways

Eszopiclone exhibits hypnotic and sedative properties through selective GABA-A receptor modulation, enhancing GABAergic neurotransmission for sleep induction and maintenance in insomnia treatment.

GABA-A Receptor Modulation

Selective binding to GABA-A receptor α1 subunit

Enhances GABAergic inhibition
Sleep Induction

Reduces sleep onset latency and improves sleep quality

Promotes faster sleep initiation
S-Enantiomer Activity

Active S-enantiomer of zopiclone with enhanced selectivity

Reduced side effects profile
Sleep Maintenance

Maintains sleep continuity throughout the night

Reduces nocturnal awakenings

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures controlled substance pharmaceutical manufacturing access with complete documentation packages supporting international standards and hypnotic drug development.

USP Standards

United States Pharmacopeia controlled substance specifications

EP Monograph

European Pharmacopoeia specifications for hypnotic agents

Controlled Substance GMP

Specialized GMP for controlled substance manufacturing

ICH Guidelines

International hypnotic drug development regulatory compliance

Controlled Substance DMF

Drug Master File for controlled substance applications

DEA Registration

Comprehensive controlled substance compliance documentation

Technical Support & Value-Added Services

DRAVYOM's controlled substance pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Eszopiclone hypnotic applications.

Hypnotic Formulation
  • Sleep aid formulation optimization
  • Controlled release development
  • Bioavailability enhancement
  • Custom hypnotic development
Analytical Services
  • API purity and potency analysis
  • Controlled substance impurity profiling
  • Enantiomeric purity testing
  • Method validation support
Regulatory Support
  • Controlled substance regulatory filing
  • DEA registration assistance
  • International compliance guidance
  • Controlled substance pharmacovigilance
Secure Supply
  • Controlled substance supply chain
  • Security-compliant packaging
  • Secure distribution network
  • Emergency controlled substance supply

Environmental Impact & Sustainability

Our Eszopiclone production emphasizes environmental responsibility through sustainable controlled substance manufacturing practices, secure waste management, and comprehensive environmental impact control.

Secure Waste Management

Controlled substance waste treatment and disposal protocols

Water Conservation

Advanced water treatment and recycling systems

Secure Production

Energy-efficient secure manufacturing processes

Environmental Security

Comprehensive controlled substance environmental protocols

ISO 14001

Environmental management for controlled substances

Sustainable Sourcing

Responsible procurement of controlled substance materials

Manufacturing Excellence & Quality Control

DRAVYOM's controlled substance manufacturing facility employs advanced security and synthesis technology with continuous monitoring systems to ensure consistent Eszopiclone quality and therapeutic performance.

Secure GMP

DEA-compliant manufacturing in secure controlled environment

Multi-stage purification with controlled substance security
Quality Testing

Comprehensive testing including assay, impurities, and stability

HPLC verification and controlled substance analysis
Quality Systems

ISO 9001:2015 with DEA controlled substance compliance

Continuous improvement and controlled substance validation
Secure Packaging

Tamper-evident containers with controlled substance labeling

Security protection and contamination prevention

Market Applications & Performance Data

Comprehensive sleep disorder data demonstrating Eszopiclone effectiveness in insomnia treatment with quantified performance metrics and clinical validation data.

Sleep Aid Formulations
Bioavailability: 52-59% oral bioavailability Stability: 3-year shelf life validated Compatibility: Excellent with tablet excipients
Therapeutic Applications
Insomnia: Proven sleep induction and maintenance Sleep Quality: Improved sleep continuity Safety: Well-tolerated hypnotic profile
Manufacturing Performance
Yield: 96% pharmaceutical grade recovery Purity: >99.5% controlled substance specification Consistency: 99.8% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Controlled Substance Excellence

Superior controlled substance pharmaceutical grade with proven hypnotic performance and DEA compliance

Secure Supply

Guaranteed controlled substance supply with secure inventory management and specialized production

Sleep Medicine Expertise

Dedicated sleep medicine development team with specialized hypnotic formulation support

DEA Compliance

Complete controlled substance documentation with DEA registration and international compliance

Global Standards

International controlled substance compliance with USP, EP, and ICH guidelines

Secure Partnership

Collaborative controlled substance relationships with specialized secure services