Nicotine USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Nicotine USP/EP

High-purity pharmaceutical grade Nicotine manufactured under stringent cGMP conditions. This stimulant API is essential for smoking cessation therapy, particularly in nicotine replacement treatment and addiction management, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥99.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Stimulant for Smoking Cessation
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C10H14N2
CAS Number: 54-11-5
EINECS Number: 200-193-3
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: Colorless to pale yellow liquid
Molecular Weight: 162.23 g/mol
Boiling Point: 247°C
pH (1% solution): 8.0-10.0
Water Content: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Miscible with water, ethanol
Storage Conditions: Store below 25°C, protect from light
Shelf Life: 3 years from manufacture date
Packaging Options: 1kg, 5kg, 25kg amber bottles

Applications

Smoking Cessation Therapy
Nicotine Replacement Patches
Nicotine Gum Formulations
Nasal Spray Preparations
Addiction Research
Sublingual Tablets
Neurological Studies
Injectable Solutions
Behavioral Research
Plant-derived Alkaloids
Pharmacokinetic Studies
Drug Development

Industry-Specific Grades

DRAVYOM offers specialized Nicotine grades tailored for specific pharmaceutical applications, ensuring optimal therapeutic efficacy and regulatory compliance across diverse smoking cessation 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: Behavioral studies
Transdermal Grade
Purity: ≥99.5% Permeation: Optimized Stability: Extended Application: Patch formulations

Quality Standards

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

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

Advanced Chemical Properties & Performance

Pharmaceutical Grade Nicotine exhibits exceptional chemical properties essential for smoking cessation applications. Its optimal alkaloid structure and superior stability characteristics ensure reliable performance in demanding nicotine replacement therapy formulations.

Molecular Properties
Molecular Weight: 162.23 g/mol
Molecular Formula: C10H14N2
LogP (Octanol/Water): 1.17
pKa: 3.12, 8.02
Physical Properties
Boiling Point: 247°C
Appearance: Colorless to pale yellow liquid
Density: 1.01 g/cm³ at 20°C
Vapor Pressure: 5.5 Pa at 25°C
Pharmaceutical Properties
Bioavailability (Transdermal): 68-77%
Protein Binding: ≤5%
Half-life: 1-2 hours
Mechanism: Nicotinic acetylcholine receptor agonist
Quality Specifications
Purity (GC): ≥99.0%
Water Content: ≤0.5%
Related Substances: ≤1.0%
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 2 years (unopened)
Storage Temperature: 2-8°C (refrigerated)
Light Sensitivity: Store in amber containers
Oxidation Sensitivity: Protect from air exposure

Performance Characteristics

Detailed performance metrics demonstrate Nicotine superiority in smoking cessation applications with exceptional receptor binding affinity, transdermal delivery, and therapeutic efficacy across diverse nicotine replacement therapy protocols.

Receptor Binding

High affinity for nicotinic acetylcholine receptors

Effective craving reduction
Transdermal Delivery

Excellent skin permeation characteristics

Sustained release profiles
Cessation Efficacy

Proven smoking cessation support

Reduced withdrawal symptoms
CNS Activity

Rapid CNS penetration and activity

Quick therapeutic onset
Clinical Performance

FDA-approved for smoking cessation

Proven therapeutic effectiveness
Formulation Versatility

Compatible with multiple dosage forms

Flexible pharmaceutical applications

Safety Information

Highly toxic pharmaceutical active ingredient requiring specialized handling protocols. Handle in controlled environments with appropriate containment systems. Use proper personal protective equipment and follow established safety protocols for toxic alkaloids.

Highly Toxic
Containment Required
Specialized PPE Mandatory

Storage & Handling

Store in tightly sealed amber containers under refrigerated conditions (2-8°C) in a secure, well-ventilated area. Protect from light, air, and moisture. Handle in controlled environments with proper containment systems and specialized safety protocols for toxic alkaloids.

Refrigerated storage (2-8°C)
Amber containers mandatory
Secure containment required
Adequate ventilation essential

Chemical Mechanisms & Reaction Pathways

Nicotine demonstrates complex neurochemical mechanisms through nicotinic acetylcholine receptor binding, enabling therapeutic applications in smoking cessation and neurological disorders with well-characterized pharmacological profiles.

Receptor Binding

Nicotinic acetylcholine receptor agonist activity

Neuronal stimulation and neurotransmitter release
Dopamine Release

Mesolimbic dopamine pathway activation

Addiction potential and therapeutic effects
Cardiovascular Effects

Sympathetic nervous system stimulation

Increased heart rate and blood pressure
Pharmacokinetic Profile

Rapid absorption with hepatic metabolism

Multiple delivery routes available

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 Nicotine performance in pharmaceutical applications.

Formulation Development
  • Transdermal delivery systems
  • Controlled-release formulations
  • Gum and lozenge development
  • Inhalation products
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Stability testing programs
  • Bioanalytical support
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Flexible packaging options
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

Our Nicotine 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 Nicotine 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 purity and potency

GC-MS, HPLC, and pharmacopeial methods
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and validation protocols
Packaging Control

Controlled atmosphere packaging with stability maintenance

Moisture and light protection systems

Market Applications & Performance Data

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

Pharmaceutical Manufacturing
Bioavailability: Multiple delivery routes Stability: 2+ years shelf life Purity: >99% pharmaceutical grade
Drug Development
Formulation Support: Smoking cessation aids Regulatory Success: Global approvals achieved Innovation: Novel delivery systems
Clinical Applications
Efficacy: Proven smoking cessation aid Safety: Controlled therapeutic use Convenience: Multiple dosage forms

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