Pregabalin
Pharmaceutical Premium
Pharmaceutical API

Pregabalin

High-purity pharmaceutical grade Pregabalin 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: C8H17NO2
CAS Number: 148553-50-8
EINECS Number: Not applicable
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to off-white crystalline powder
Molecular Weight: 159.23 g/mol
Melting Point: 194-196°C
pH (1% solution): 6.0-8.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Freely soluble in water
Storage Conditions: Store at 15-30°C, protect from light
Shelf Life: 3 years from manufacture date
Packaging Options: 1kg, 5kg, 25kg containers

Applications

Neuropathic Pain
Epilepsy Treatment
Oral Capsule Formulations
Tablet Preparations
Fibromyalgia Treatment
GABA Analog Activity
Anxiety Disorders
Generalized Anxiety Disorder
Neurological Research
Clinical Trials
CNS Drug Development
Regulatory Studies

Industry-Specific Grades

DRAVYOM offers specialized Pregabalin grades tailored for specific neurological applications, ensuring optimal GABA analog activity and regulatory compliance across diverse pharmaceutical formulations.

USP Grade (United States Pharmacopoeia)
Purity: ≥99.0% Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: FDA approved formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% Related Substances: ≤1.0% Residual Solvents: EP limits Application: European market compliance
Research Grade
Purity: ≥98.0% Activity: Verified Stability: Enhanced Application: Neurological research
Oral Formulation Grade
Purity: ≥99.5% Particle Size: Controlled Bioavailability: Optimized Application: Oral dosage forms

Quality Standards

DRAVYOM's Pregabalin is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and FDA guidelines for neurological therapy applications.

cGMP Manufacturing Standards
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
GABA Activity Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Controlled Storage & Shipping

Advanced Chemical Properties & Performance

Pharmaceutical Grade Pregabalin exhibits exceptional chemical properties essential for neurological applications. Its potent GABA analog structure and superior stability characteristics ensure reliable performance in demanding neuropathic pain and epilepsy treatment formulations.

Molecular Properties
Molecular Weight: 159.23 g/mol
Molecular Formula: C8H17NO2
LogP (Octanol/Water): -1.35
pKa: 4.2, 10.6
Physical Properties
Melting Point: 194-196°C
Appearance: White crystalline powder
Solubility (Water): Freely soluble
Bulk Density: 0.45-0.55 g/cm³
Pharmaceutical Properties
Bioavailability: ≥90%
Protein Binding: 0%
Half-life: 6.3 hours
Mechanism: Calcium channel α2δ subunit binding
Quality Specifications
Purity (HPLC): ≥99.0%
Water Content: ≤0.5%
Related Substances: ≤1.0%
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-25°C
Light Sensitivity: Store in light-resistant containers
Moisture Sensitivity: Store in dry conditions

Performance Characteristics

Detailed performance metrics demonstrate Pregabalin superiority in neurological applications with exceptional neuropathic pain relief, anticonvulsant activity, and therapeutic efficacy across diverse neurological condition treatment protocols.

Neuropathic Pain Relief

Superior efficacy in diabetic neuropathy and fibromyalgia

Significant pain reduction
Calcium Channel Binding

High affinity α2δ subunit modulation

Reduced neurotransmitter release
Anticonvulsant Activity

Effective partial seizure control

Adjunctive epilepsy therapy
Rapid Absorption

6.3-hour elimination half-life

Multiple daily dosing flexibility
Clinical Efficacy

FDA-approved for neuropathic pain and epilepsy

Proven neurological benefits
High Bioavailability

≥90% oral absorption with linear kinetics

Predictable dosing response

Safety Information

Controlled substance pharmaceutical active ingredient requiring specialized handling protocols. Handle in controlled environments with appropriate security measures. Use proper personal protective equipment and follow established safety protocols for CNS-active compounds.

Controlled Substance
Security Required
Specialized Handling

Storage & Handling

Store in tightly closed, light-resistant containers in a cool, dry place away from direct sunlight. Maintain controlled room temperature storage in secure areas with appropriate access controls and documentation for controlled substances.

Controlled room temperature (15-25°C)
Secure storage required
Light-resistant containers
Documentation required

Chemical Mechanisms & Reaction Pathways

Pregabalin functions as a selective calcium channel modulator with anticonvulsant and analgesic properties, providing effective treatment for neuropathic pain and epilepsy through α2δ subunit binding and reduced neurotransmitter release.

Calcium Channel Modulation

Selective binding to α2δ subunit of voltage-gated calcium channels

Reduces calcium influx and neurotransmitter release
Neuropathic Pain Relief

Inhibits excessive neuronal excitability and pain transmission

Provides analgesic effects
Anticonvulsant Activity

Stabilizes neuronal membranes and prevents seizures

Effective epilepsy management
GABA Analog Structure

Structural analog of GABA with enhanced CNS penetration

Improved bioavailability and efficacy

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical acceptance with complete documentation packages supporting international drug development and manufacturing requirements.

USP Specifications

United States Pharmacopeia pharmaceutical grade compliance

EP Standards

European Pharmacopoeia specifications and testing protocols

ICH Guidelines

International harmonized pharmaceutical development standards

Global Regulatory

Multi-regional pharmaceutical registration support

DMF Support

Drug Master File preparation and regulatory submission

GMP Compliance

Good Manufacturing Practice certified production

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, analytical method development, and regulatory assistance to optimize Pregabalin performance in pharmaceutical applications.

Formulation Development
  • Capsule formulation optimization
  • Bioavailability enhancement
  • Extended release formulations
  • Stability improvement strategies
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Stability testing programs
  • Pharmacokinetic studies
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Controlled storage packaging
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

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

Green Chemistry

Environmentally conscious synthesis with minimal waste

Water Management

Advanced wastewater treatment and recycling systems

Energy Efficiency

Optimized manufacturing processes with reduced energy consumption

Waste Reduction

Comprehensive waste minimization and disposal protocols

ISO 14001

Environmental management system certified production

Carbon Footprint

Reduced environmental impact through sustainable practices

Manufacturing Excellence & Quality Control

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

GMP Production

Good Manufacturing Practice certified facility with controlled environments

Pharmaceutical-grade production standards
Quality Testing

Comprehensive analytical testing including potency and purity

HPLC, LC-MS, and bioactivity assays
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and validation protocols
Packaging Control

Moisture-controlled packaging with stability protection

Drug stability and quality maintenance

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating Pregabalin effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation.

Pharmaceutical Manufacturing
Bioavailability: >90% oral absorption Half-life: 6.3 hours elimination Purity: >99.5% pharmaceutical grade
Drug Development
Formulation Support: Neurological therapies Regulatory Success: Global approvals achieved Innovation: Calcium channel modulation
Clinical Applications
Efficacy: Neuropathic pain and epilepsy Safety: Established neurological profile Specialization: CNS disorders

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds USP/EP specifications with pharmaceutical-grade quality and performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production

Development Expertise

Dedicated pharmaceutical team provides formulation development and regulatory support

Quality Assurance

Comprehensive documentation with pharmaceutical-grade certificates and regulatory compliance

Global Standards

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

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services