Zolpidem Pharmaceutical API
Pharmaceutical Premium
Pharmaceutical API

Zolpidem

High-purity pharmaceutical grade Zolpidem API manufactured to meet stringent USP/EP specifications for sleep disorder medication production. Our pharmaceutical-grade Zolpidem delivers exceptional quality and consistency for critical pharmaceutical applications.

  • USP/EP Compliant Grade
  • High Purity (>99.5%)
  • Insomnia Treatment API
  • GMP Certified Manufacturing
  • Reliable Supply Chain
  • Complete Documentation
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Technical Specifications

Chemical Formula: C19H21N3O
CAS Number: 82626-48-0
Molecular Weight: 307.39 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.5% (USP/EP Grade)
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤0.5% (total impurities)
Particle Size: D90 ≤ 100 μm
pH (1% solution): 5.0-7.0
Solubility: Sparingly soluble in water
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

Sleep Disorder Treatment
Oral Tablet Formulations
Capsule Formulations
Insomnia Medication
Neurological Applications
Sleep Medicine
Immediate Release Formulations
Prescription Medications
Sleep Research
Controlled Release Tablets
Regulatory Submissions
Reference Standards

Industry-Specific Grades

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

USP Grade (United States Pharmacopeia)
Purity: ≥99.5% (HPLC) Related Substances: ≤0.5% Heavy Metals: ≤10 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.5% (HPLC) Loss on Drying: ≤0.5% pH: 5.0-7.0 (1% solution) Application: EU regulatory submissions
Sleep Grade
Purity: ≥99.8% (HPLC) Hypnotic Activity: Verified Bioavailability: Optimized Application: Sleep disorder medications
Immediate Release Grade
Purity: ≥99.9% (HPLC) Dissolution Rate: Verified Particle Size: Controlled Application: Immediate release formulations

Quality Standards

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

ISO 9001:2015 Certified Manufacturing
USP/EP Grade Specifications
≥99.5% HPLC Purity
Advanced Sleep Disorder Testing
Hypnotic Activity Verified
Batch-to-Batch Consistency
Comprehensive COA
Pharmaceutical Grade Packaging

Advanced Chemical Properties & Performance

Pharmaceutical Grade Zolpidem exhibits exceptional chemical properties essential for sleep disorder applications. Its imidazopyridine hypnotic composition and precise specification ensure reliable performance in demanding pharmaceutical formulations and neurological treatment systems.

Chemical Properties
Molecular Formula: C₁₉H₂₁N₃O
Molecular Weight: 307.39 g/mol
Melting Point: 196-200°C
LogP (Octanol/Water): 3.0
Physical Properties
Appearance: White to off-white crystalline powder
Solubility: Sparingly soluble in water
pH (saturated solution): 6.0-7.5
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Bioavailability: 70% (oral)
Half-life: 2.5 hours
Protein Binding: 92.5%
Mechanism: GABA-A receptor modulator
Purity Specifications
Assay (HPLC): ≥ 99.5%
Related Substances: ≤ 0.3%
Heavy Metals: ≤ 20 ppm
Residual Solvents: Within ICH limits
Stability Properties
Shelf Life: 3 years (unopened)
Photostability: Stable under normal light
Temperature Stability: Stable 15-25°C
Humidity Stability: Store ≤60% RH

Performance Characteristics

Detailed performance metrics demonstrate Pharmaceutical Grade Zolpidem superiority in sleep disorder applications with exceptional functionality, stability, and reproducibility across diverse pharmaceutical procedures and neurological protocols.

Hypnotic Efficacy

Potency: Selective GABA-A receptor modulator

Superior sleep induction
Onset of Action

Time: 15-30 minute sleep onset

Rapid therapeutic effect
Bioavailability

Absorption: 70% oral bioavailability

Reliable therapeutic levels
Formulation Stability

Range: Stable in standard formulations

Consistent performance across dosage forms
Batch Uniformity

Variation: ±0.3% between production batches

Exceptional pharmaceutical grade consistency
Long-term Stability

3 years shelf life with maintained potency

Extended pharmaceutical grade integrity

Safety Information

Controlled substance with potential for abuse and dependence. Prescription pharmaceutical requiring careful dosing and monitoring. Generally well-tolerated hypnotic agent with established safety profile. Handle with standard laboratory precautions including appropriate protective equipment. Avoid inhalation of powder and ensure proper ventilation during processing.

Controlled Substance
Sleep Active
Medical Supervision

Storage & Handling

Store in original sealed containers in a cool, dry, well-ventilated area away from light and moisture. Keep containers tightly closed and protect from degradation. Use appropriate pharmaceutical handling procedures with controlled substance protocols and ensure proper environmental controls for stability management.

Cool storage (15-25°C)
Low humidity (≤60% RH)
Controlled substance security
Original sealed containers

Chemical Mechanisms & Reaction Pathways

Pharmaceutical Grade Zolpidem exhibits selective GABA-A receptor modulation properties through imidazopyridine structure enabling effective sleep induction with reduced dependency potential and minimal residual sedation compared to benzodiazepines.

GABA-A Modulation

Selective binding to alpha-1 subunit of GABA-A receptors

Primary mechanism for sleep induction without muscle relaxation
Sleep Architecture

Preserves normal sleep stages with minimal REM suppression

Maintains natural sleep quality and restorative phases
Rapid Onset

Fast absorption and CNS penetration within 30 minutes

Quick sleep onset with short half-life
Reduced Tolerance

Lower potential for dependency and tolerance development

Improved safety profile for chronic use

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical market access with complete API documentation supporting international standards and controlled substance manufacturing validations.

USP Specifications

United States Pharmacopeia API standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical manufacturing

FDA Approved

FDA approved sleep medication API with comprehensive safety data

International Approval

Global regulatory compliance for sleep disorder applications

DMF Documentation

Drug Master File with comprehensive manufacturing and safety data

Controlled Substance

Schedule IV controlled substance with appropriate security protocols

Technical Support & Value-Added Services

DRAVYOM's CNS API team provides comprehensive development support, formulation optimization assistance, and regulatory services for sleep medication manufacturing with specialized neurological expertise.

API Development
  • Sleep disorder formulation support
  • Bioavailability enhancement studies
  • Stability optimization protocols
  • Extended-release development
Analytical Services
  • Certificate of Analysis with CNS testing
  • Polymorphic form characterization
  • Impurity profiling and identification
  • Dissolution study support
Regulatory Support
  • Sleep medication documentation
  • Controlled substance filing assistance
  • Clinical trial support
  • Post-market surveillance
Secure Supply
  • Controlled substance supply chains
  • Enhanced security protocols
  • Emergency supply protocols
  • Global distribution network

Environmental Impact & Sustainability

Our Pharmaceutical Grade Zolpidem production emphasizes environmental responsibility through green chemistry principles, sustainable synthetic pathways, and comprehensive environmental impact management for API manufacturing.

Green Synthesis

Optimized synthetic routes with minimal environmental impact

Solvent Recovery

Advanced solvent recycling and waste minimization

Clean Production

Energy-efficient synthesis with emission controls

Water Treatment

Advanced wastewater treatment and recycling systems

ISO 14001

Environmental management system certified production

Secure Disposal

Controlled substance waste management protocols

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art CNS API manufacturing facility employs advanced synthetic technology and continuous monitoring systems to ensure consistent Pharmaceutical Grade Zolpidem quality and therapeutic efficacy.

Controlled Production

Advanced multi-step synthesis with enhanced security protocols

Controlled synthesis for optimal purity and security
Quality Testing

28-point pharmaceutical testing protocol including stereochemical analysis

HPLC verification and CNS-specific testing
Quality Systems

cGMP compliance with controlled substance manufacturing standards

Enhanced security and quality protocols
Secure Packaging

Specialized packaging with tamper-evident protection

Stability maintenance and security compliance

Market Applications & Performance Data

Comprehensive clinical and pharmaceutical data demonstrating Pharmaceutical Grade Zolpidem effectiveness across diverse sleep disorder applications with quantified therapeutic metrics and safety profiles.

Insomnia Treatment
Sleep Latency: 15-30 minute reduction to sleep onset Sleep Duration: 6-8 hours of continuous sleep Efficacy: 80-90% improvement in sleep quality
Safety Profile
Tolerance: Reduced potential vs benzodiazepines Morning Hangover: Minimal residual sedation Memory: Less anterograde amnesia risk
Clinical Applications
Short-term Insomnia: Primary indication for acute treatment Travel: Jet lag and sleep schedule adjustment Elderly: Reduced dosing with maintained efficacy

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmacopeial specifications with optimal stereochemical control and impurity profile

Reliable Supply

Guaranteed availability with strategic inventory management and controlled substance expertise

API Expertise

Specialized CNS API manufacturing with comprehensive sleep medication development support

Quality Assurance

Enhanced testing protocols with complete documentation and regulatory compliance

Global Standards

International compliance with USP, EP, and controlled substance regulations worldwide

Partnership Approach

Collaborative relationships with neurological pharmaceutical companies and specialized development support