Gabapentin
Pharmaceutical Premium
Pharmaceutical API

Gabapentin

High-purity pharmaceutical grade Gabapentin 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: C9H17NO2
CAS Number: 60142-96-3
Molecular Weight: 171.24 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

Anticonvulsant Drug Manufacturing
Neuropathic Pain Formulations
Epilepsy Treatment Products
API Synthesis & Development
Neurological Research
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 Gabapentin grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse anticonvulsant and neuropathic pain 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: Neurological formulations

Quality Standards

DRAVYOM's pharmaceutical grade Gabapentin 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 Gabapentin exhibits precise chemical properties essential for neurological formulations. Its ultra-pure composition and exact molecular structure ensure reliable therapeutic performance in demanding pharmaceutical applications.

Pharmaceutical Properties
Molecular Weight: 171.24 g/mol
Melting Point: 162-166°C
Solubility (Water): 4.2 mg/mL at 25°C
pKa: 3.7, 10.7
Physical Properties
Appearance: White to off-white powder
Crystalline Form: Crystalline solid
Bulk Density: 0.50-0.60 g/mL
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Bioavailability: 60% oral bioavailability
Half-life: 5-7 hours
Protein Binding: 3%
Metabolism: Not metabolized
Purity Specifications
Assay: ≥99.0% (HPLC)
Related Substances: ≤0.1% total
Residual Solvents: ICH Q3C compliant
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-30°C
Light Sensitivity: Protect from light
Moisture Sensitivity: Store in dry conditions

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Gabapentin superiority in neurological applications with exceptional stability, bioavailability, and reproducibility across diverse pharmaceutical formulations.

Formulation Performance

Compatibility: Excellent with standard excipients

Consistent capsule formulation
Therapeutic Efficacy

Bioequivalence: 90-110% reference standard

Proven therapeutic equivalence
Dissolution Profile

Release: >75% in 45 minutes (USP)

Optimal pharmaceutical performance
Thermal Stability

Stability: <0.1% degradation/year at 25°C

Excellent long-term stability
Batch Consistency

Variation: ±0.5% between production batches

Exceptional pharmaceutical uniformity
Shelf Stability

3 years under controlled storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade neurological compound requiring proper handling procedures. Use appropriate personal protective equipment including gloves, safety goggles, and protective clothing. Ensure adequate ventilation and follow established pharmaceutical handling protocols.

Handle with Care
Eye Protection Required
Avoid Inhalation

Storage & Handling

Store in original pharmaceutical containers in a cool, dry, well-ventilated area away from incompatible materials. Keep containers tightly closed and protect from light and moisture. Follow cGMP storage requirements for pharmaceutical materials.

Controlled temperature (15-30°C)
Protect from moisture
Original pharmaceutical packaging
Protect from direct light

Chemical Mechanisms & Reaction Pathways

Gabapentin exhibits unique pharmacological mechanisms through selective interaction with neuronal calcium channels, enabling precise neurological therapeutic applications with predictable pharmacokinetic and pharmacodynamic pathways.

Calcium Channel Binding

Selective binding to α2δ subunit of voltage-gated calcium channels

Modulates neurotransmitter release in CNS
GABA Pathway Interaction

Indirect GABAergic modulation without direct GABA receptor binding

Enhances inhibitory neurotransmission
Membrane Transport

LAT1 transporter-mediated blood-brain barrier penetration

Enables CNS therapeutic targeting
Metabolic Stability

Minimal hepatic metabolism with renal elimination pathway

Predictable pharmacokinetic profile

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical access with complete documentation packages supporting international standards and drug development validations.

USP Specifications

United States Pharmacopeia pharmaceutical grade standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical manufacturing

cGMP Manufacturing

Current Good Manufacturing Practice certified production facility

ICH Guidelines

International Conference on Harmonisation quality standards

DMF Support

Drug Master File documentation for regulatory submissions

Quality Documentation

Complete analytical documentation package with stability data

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, analytical method development, and regulatory guidance to optimize Gabapentin performance in your specific pharmaceutical applications.

Formulation Development
  • Dosage form optimization support
  • Excipient compatibility studies
  • Bioavailability enhancement guidance
  • Custom formulation protocols
Analytical Services
  • Certificate of Analysis verification
  • Custom impurity profiling
  • Method validation support
  • Stability testing programs
Technical Support
  • Pharmaceutical troubleshooting consultation
  • cGMP compliance guidance
  • Process optimization support
  • Quality system implementation
Supply Solutions
  • Consistent batch scheduling
  • Emergency supply arrangements
  • Custom packaging options
  • Global pharmaceutical distribution

Environmental Impact & Sustainability

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

Waste Minimization

Optimized synthesis with minimal pharmaceutical waste generation

Water Treatment

Advanced pharmaceutical wastewater treatment and recycling systems

Green Chemistry

Environmentally conscious synthesis with emission controls

Safe Disposal

Comprehensive guidance for pharmaceutical waste management

ISO 14001

Environmental management system certified pharmaceutical production

Carbon Footprint

Reduced carbon footprint through process optimization

Manufacturing Excellence & Quality Control

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

Production Process

Advanced synthesis and purification in controlled cGMP environment

Multi-stage crystallization for pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing protocol including related substances analysis

HPLC verification and spectroscopic analysis
Quality Systems

ISO 9001:2015 quality management with pharmaceutical manufacturing accreditation

Continuous improvement and process validation
Packaging Control

Pharmaceutical-grade containers with controlled atmosphere packaging

Moisture protection and contamination prevention

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating Gabapentin effectiveness across diverse therapeutic applications with quantified performance metrics and clinical development validations.

Pharmaceutical Manufacturing
Bioavailability: >90% oral absorption Stability: 3+ years shelf life Purity: >99.5% pharmaceutical grade
Clinical Development
Efficacy: Proven neurological applications Safety: Well-established safety profile Regulatory: Multiple country approvals
Manufacturing Scale
Capacity: Multi-ton annual production Consistency: <0.1% batch-to-batch variation Compliance: 100% cGMP adherence

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds USP/EP 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

Comprehensive certificates with complete analytical data and regulatory documentation

Global Standards

International compliance with USP, EP, and ICH specifications for worldwide pharmaceutical acceptance

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom API development services