Lemborexant USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Lemborexant USP/EP

High-purity pharmaceutical grade Lemborexant manufactured under stringent cGMP conditions. This dual orexin receptor antagonist API is essential for insomnia treatment, particularly in sleep disorder management, providing reliable quality and regulatory compliance for sleep medicine therapeutics.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥99.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Dual Orexin Receptor Antagonist for Insomnia
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C23H23N3O2
CAS Number: 1350820-25-9
EINECS Number: Not Available
Molecular Weight: 373.45 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Melting Point: 198-202°C
pH (1% solution): 5.5-7.5
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% (total impurities)
Storage Conditions: Store at room temperature, protect from light
Shelf Life: 3 years from date of manufacture
Packaging Options: 25g, 50g, 100g pharmaceutical containers

Applications

Oral Tablet Formulations
Sleep Disorder Treatment
Insomnia Therapy
Orexin Receptor Antagonist
Sleep Medicine Research
Hospital Sleep Centers
Pharmaceutical Manufacturing
Sleep Aid Medications
Sleep Disorder Research
Clinical Trials
Regulatory Submissions
Reference Standards

Industry-Specific Grades

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

USP Grade (United States Pharmacopeia)
Purity: ≥99.0% (HPLC) Related Substances: ≤1.0% Heavy Metals: ≤10 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (HPLC) Impurities: Individual ≤0.5% Loss on Drying: ≤0.5% Application: EU regulatory submissions
Sleep Medicine Research Grade
Purity: ≥99.5% (HPLC) Water Content: ≤0.2% Residue on Ignition: ≤0.05% Application: Sleep disorder research
Reference Standard Grade
Purity: ≥99.8% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

DRAVYOM's Lemborexant API is manufactured under stringent quality control protocols, meeting international pharmaceutical standards including USP, EP, and cGMP specifications. Our pharmaceutical-grade production ensures consistent performance and regulatory compliance.

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
Ultra-Low Impurity Levels
Batch-to-Batch Consistency
Comprehensive Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Lemborexant exhibits exceptional pharmaceutical properties essential for sleep medicine applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding therapeutic procedures and research applications.

Molecular Properties
Binding Affinity (Ki): 2.6 nM (OX2R), 5.4 nM (OX1R)
Selectivity Ratio: 2.1-fold OX2R selective
Bioavailability: ~90% (oral administration)
Half-life (t½): 17-19 hours
Physical Properties
Melting Point: 154-156°C
Solubility (water): Slightly soluble
Log P (octanol/water): 3.2
Crystalline Form: White to off-white powder
Pharmaceutical Performance
Assay Accuracy: ±0.5% relative
Impurity Control: Each ≤0.15%, total ≤0.5%
Dissolution Rate: ≥85% in 30 minutes
Polymorphic Form: Stable Form A
Purity Specifications
Total Impurities: ≤1.0%
Organic Impurities: ≤0.5%
Water Content: ≤0.5%
Residue on Ignition: ≤0.1%
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Stable 2-8°C
Container Compatibility: HDPE, glass containers

Performance Characteristics

Detailed performance metrics demonstrate Lemborexant API superiority in pharmaceutical applications with exceptional efficacy, safety, and reproducibility across diverse therapeutic protocols and manufacturing procedures.

Therapeutic Performance

Efficacy: Superior sleep onset and maintenance

Exceptional clinical performance
Receptor Binding

Selectivity: High affinity for orexin receptors

Minimal off-target effects
Formulation Compatibility

Stability: Compatible with standard excipients

Excellent tablet/capsule formation
Process Stability

Manufacturing: Stable during processing

Consistent batch performance
Batch Reproducibility

Variation: ±2.0% between batches

Exceptional lot-to-lot consistency
Shelf Stability

3 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical API requiring careful handling and appropriate safety measures. Handle in controlled environments with appropriate protective equipment including nitrile gloves, safety goggles, and protective clothing. Avoid inhalation of dust and ensure proper ventilation and emergency procedures are in place.

Pharmaceutical API
Avoid Inhalation
Controlled Handling

Storage & Handling

Store in original sealed containers in a cool, dry, well-ventilated area away from incompatible materials. Keep containers tightly closed and protect from light and moisture. Use appropriate pharmaceutical-grade storage equipment and ensure proper environmental controls for API preservation.

Controlled temperature (2-8°C)
Low humidity environment
Original pharmaceutical containers
Protect from light exposure

Chemical Mechanisms & Reaction Pathways

Lemborexant exhibits selective orexin receptor antagonism for sleep-wake cycle regulation, enabling precise insomnia treatment applications with predictable pharmacokinetic pathways and quantitative orexin pathway modulation.

Orexin Receptor Antagonism

Dual antagonism of orexin receptor 1 and 2 (OX1R/OX2R)

Therapeutic mechanism for sleep induction
Sleep-Wake Regulation

Modulation of arousal and sleep-wake transition

Essential for insomnia treatment
REM Sleep Preservation

Maintenance of normal sleep architecture

Enables selective therapeutic applications
CNS Selectivity

Selective central nervous system activity

Controlled therapeutic environment for sleep disorders

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical market access with complete documentation packages supporting international standards and therapeutic method validations.

USP Grade Specifications

United States Pharmacopeia pharmaceutical grade standards compliance

EP Monograph Standard

European Pharmacopoeia standard for pharmaceutical specifications

IP Grade Available

Indian Pharmacopoeia specifications for pharmaceutical analysis

ICH Guidelines

International Conference on Harmonisation pharmaceutical compliance

Method Validation

Supported pharmaceutical method validation documentation

SDS Documentation

Multi-language Safety Data Sheets (16 sections, GHS compliant)

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, stability testing, and regulatory services to optimize Lemborexant performance in your specific pharmaceutical applications.

Formulation Development
  • Pharmaceutical formulation optimization support
  • Stability testing guidance
  • Bioavailability and bioequivalence studies
  • Custom pharmaceutical procedures
Analytical Services
  • Certificate of Analysis verification
  • Custom purity analysis
  • Impurity profiling and identification
  • Method validation support
Technical Support
  • Pharmaceutical troubleshooting consultation
  • Storage and handling guidance
  • Safety training and protocols
  • cGMP best practices
Supply Solutions
  • Consistent batch scheduling
  • Emergency supply arrangements
  • Custom packaging options
  • Global distribution network

Environmental Impact & Sustainability

Our Lemborexant production emphasizes environmental responsibility through sustainable manufacturing practices, waste minimization, and comprehensive environmental impact management for pharmaceutical operations.

Waste Minimization

Optimized production with minimal waste generation

Water Treatment

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive guidance for pharmaceutical waste management

ISO 14001

Environmental management system certified production

Container Recycling

Pharmaceutical container return and recycling programs

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced purification technology and continuous monitoring systems to ensure consistent Lemborexant quality and performance across all production batches.

Production Process

Advanced synthesis and purification in controlled cGMP environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing protocol including purity, impurities, and stability

HPLC verification and spectroscopic analysis
Quality Systems

ISO 9001:2015 quality management with cGMP compliance

Continuous improvement and method validation
Packaging Control

Pharmaceutical grade containers with controlled atmosphere packaging

Light protection and contamination prevention

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating Lemborexant effectiveness across diverse sleep disorder applications with quantified performance metrics and clinical validation.

Pharmaceutical Manufacturing
Purity: >99.0% pharmaceutical grade Bioavailability: >90% in formulations Stability: 2 years shelf life
Research Institutions
Publications: 100+ cited studies Clinical Trials: 15+ ongoing studies Innovation: Sleep medicine research
Contract Manufacturing
Reliability: 99.9% batch consistency Compliance: 100% regulatory approval Efficiency: 25% cost reduction

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmacopeia specifications with ultra-low impurities and exceptional pharmaceutical performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production scheduling

Pharmaceutical Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Quality Assurance

Traceable certificates with comprehensive analytical data and stability studies

Global Standards

International compliance with USP, EP, and ICH guidelines for worldwide acceptance

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom development services