Levetiracetam
Pharmaceutical Premium
Pharmaceutical API

Levetiracetam

High-purity pharmaceutical grade Levetiracetam 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
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Technical Specifications

Chemical Formula: C8H14N2O2
CAS Number: 102767-28-2
EINECS Number: Not Available
Molecular Weight: 170.21 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Melting Point: 117-119°C
pH (1% solution): 6.0-8.0
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
Injectable Formulations
Antiepileptic Therapy
Seizure Disorder Treatment
Neurological Research
Hospital Neurology Units
Pharmaceutical Manufacturing
Epilepsy Medications
Epilepsy Research
Clinical Trials
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Levetiracetam grades tailored for specific antiepileptic pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse neurological 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
Neurology Research Grade
Purity: ≥99.5% (HPLC) Water Content: ≤0.2% Residue on Ignition: ≤0.05% Application: Epilepsy research
Reference Standard Grade
Purity: ≥99.8% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

DRAVYOM's Levetiracetam 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

Levetiracetam exhibits exceptional pharmaceutical properties essential for antiepileptic applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and neurological treatments.

Pharmaceutical Properties
Molecular Weight: 170.21 g/mol
Solubility (Water): 104 mg/mL at 25°C
Partition Coefficient: LogP = -0.64
Bioavailability: ≥95% oral absorption
Physical Properties
Melting Point: 115-118°C
Appearance: White to off-white powder
Crystalline Form: Stable polymorphic form
Bulk Density: 0.45-0.65 g/mL
Formulation Performance
Dissolution Rate: ≥85% in 30 minutes
Tablet Hardness: 6-12 kp compatible
Compressibility: Excellent direct compression
Flow Properties: Good to excellent
Purity Specifications
Total Impurities: ≤1.0%
Related Substances: ≤0.5% individual
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Minimal degradation
Temperature Stability: Stable 15-30°C
Humidity Sensitivity: Store below 60% RH

Performance Characteristics

Detailed performance metrics demonstrate Levetiracetam superiority in pharmaceutical applications with exceptional efficacy, bioavailability, and reproducibility across diverse formulation types and therapeutic protocols.

Therapeutic Performance

Bioavailability: ≥95% oral absorption

Excellent bioequivalence in formulations
Dissolution Rate

Release: ≥85% in 30 minutes

Consistent drug release profile
Analytical Performance

Purity: ≥99.0% HPLC

Superior analytical precision
Stability Performance

Shelf life: 5 years under proper storage

Extended pharmaceutical integrity
Batch Reproducibility

Variation: ±2.0% between batches

Exceptional lot-to-lot consistency
Processing Performance

Compressibility: Excellent direct compression

Superior manufacturing efficiency

Safety Information

Pharmaceutical grade material requiring appropriate handling procedures. Use standard pharmaceutical safety protocols including proper ventilation, protective equipment, and trained personnel. Follow all applicable regulatory guidelines for pharmaceutical manufacturing and handling.

Pharmaceutical Material
Trained Personnel Required
cGMP Compliance

Storage & Handling

Store in original pharmaceutical packaging in a controlled environment. Maintain temperature and humidity conditions as specified. Use appropriate material handling equipment and ensure proper documentation for pharmaceutical traceability and regulatory compliance.

Controlled temperature (15-30°C)
Humidity control (≤60% RH)
Original pharmaceutical packaging
Complete documentation required

Chemical Mechanisms & Reaction Pathways

Levetiracetam exhibits selective anticonvulsant activity through synaptic vesicle protein SV2A binding, enabling precise seizure control applications with predictable pharmacokinetic pathways and quantitative synaptic modulation.

SV2A Binding

Selective binding to synaptic vesicle protein SV2A

Therapeutic mechanism for seizure prevention
Synaptic Modulation

Modulation of neurotransmitter release

Essential for anticonvulsant activity
Calcium Channel

Modulation of high-voltage activated calcium channels

Enables selective therapeutic applications
CNS Selectivity

Selective central nervous system penetration

Controlled therapeutic environment for epilepsy treatment

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 Levetiracetam 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 Levetiracetam 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 Levetiracetam 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 Levetiracetam effectiveness across diverse neurological applications with quantified performance metrics and clinical validation.

Pharmaceutical Manufacturing
Purity: >99.0% pharmaceutical grade Bioavailability: >95% in formulations Stability: 3 years shelf life
Research Institutions
Publications: 800+ cited studies Clinical Trials: 50+ ongoing studies Innovation: Epilepsy therapy development
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