Donepezil Hydrochloride API
Pharmaceutical Premium
Pharmaceutical API

Donepezil Hydrochloride

High-purity pharmaceutical grade Donepezil Hydrochloride API manufactured to meet stringent USP/EP specifications for Alzheimer's disease treatment formulations. Our pharmaceutical grade API delivers exceptional purity and consistency for critical drug manufacturing applications.

  • USP/EP Grade Quality Standards
  • High Purity ≥99.0% (HPLC)
  • Comprehensive Analytical Documentation
  • Regulatory Compliance Support
  • cGMP Manufacturing Standards
  • Pharmaceutical Grade Packaging
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Technical Specifications

Chemical Formula: C24H29NO3·HCl
CAS Number: 120014-06-4
Molecular Weight: 415.96 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

Alzheimer's Drug Manufacturing
Cognitive Enhancement Formulations
Oral Pharmaceutical Products
API Synthesis & Development
Acetylcholinesterase Inhibitor 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 Donepezil Hydrochloride grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse neurological 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 Donepezil Hydrochloride 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 Donepezil Hydrochloride exhibits exceptional chemical properties essential for neurological therapy applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Freely soluble
LogP (octanol/water): 2.2
pKa: 8.9
Molecular Weight: 415.96 g/mol
Physical Properties
Appearance: White crystalline powder
Melting Point: 160-162°C
Bulk Density: 0.5-0.7 g/mL
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
Bioavailability: 100% (oral)
Protein Binding: 96%
Half-life: 70 hours
Mechanism: Acetylcholinesterase inhibitor
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤0.5% total
Water Content: ≤0.5% (Karl Fischer)
Residue on Ignition: ≤0.1%
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Store below 25°C
pH Stability: Stable in neutral conditions

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Donepezil Hydrochloride superiority in neurological applications with exceptional acetylcholinesterase inhibition, cognitive enhancement, and reproducibility across diverse therapeutic protocols.

Cognitive Enhancement

Reversible acetylcholinesterase inhibition

Improves cholinergic neurotransmission
Long Half-life

Extended duration of action

Once-daily dosing convenience
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 3 years
Thermal Stability

Melting point: 160-162°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.2% between batches

Consistent therapeutic efficacy
Selective Inhibition

Selective for acetylcholinesterase

Minimal off-target effects

Safety Information

Prescription pharmaceutical ingredient requiring professional handling. Well-established safety profile for neurological therapy. Handle with pharmaceutical-grade safety precautions and ensure proper GMP environmental controls. Clinical monitoring for cholinergic effects and hepatic function during therapeutic use.

Prescription Only
Professional Use
Monitor liver function

Storage & Handling

Store in original containers in a cool, dry, well-ventilated area away from moisture and light. Keep containers tightly closed and maintain pharmaceutical-grade environmental controls. Use appropriate GMP handling techniques for API processing.

Cool storage (15-25°C)
Protect from moisture (hygroscopic)
Protect from light
GMP handling required

Chemical Mechanisms & Reaction Pathways

Donepezil Hydrochloride exhibits cognitive enhancement properties through selective acetylcholinesterase inhibition, increasing cholinergic neurotransmission and supporting memory and cognitive function.

AChE Inhibition

Selectively and reversibly inhibits acetylcholinesterase

Increases acetylcholine levels in synapses
Cholinergic Enhancement

Enhances cholinergic neurotransmission in the brain

Improves memory and cognitive function
Selective Action

Preferential binding to CNS acetylcholinesterase

Minimal peripheral cholinergic effects
Neuroprotective Effects

May provide neuroprotective benefits beyond AChE inhibition

Potential disease-modifying effects

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures neurological pharmaceutical manufacturing access with complete documentation packages supporting international standards and cognitive enhancement drug development.

USP Standards

United States Pharmacopeia neurological drug specifications

EP Monograph

European Pharmacopoeia specifications for cognitive enhancers

GMP Certification

Good Manufacturing Practices for neurological pharmaceuticals

ICH Guidelines

International neurological drug development regulatory compliance

DMF Support

Drug Master File for cognitive enhancement applications

Safety Documentation

Comprehensive neurological safety and pharmacovigilance documentation

Technical Support & Value-Added Services

DRAVYOM's neurological pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Donepezil Hydrochloride cognitive enhancement applications.

Formulation Development
  • Neurological formulation optimization
  • Bioavailability enhancement
  • Stability testing protocols
  • Custom neurological development
Analytical Services
  • API purity and potency analysis
  • Neurological impurity profiling
  • Pharmaceutical testing services
  • Method validation support
Regulatory Support
  • Neurological regulatory filing
  • DMF preparation and maintenance
  • International compliance guidance
  • Pharmacovigilance support
Supply Solutions
  • Reliable pharmaceutical supply chain
  • Custom packaging solutions
  • Global distribution network
  • Emergency supply arrangements

Environmental Impact & Sustainability

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

Green Chemistry

Environmentally friendly synthesis and processing methods

Water Conservation

Advanced water treatment and recycling systems

Clean Production

Energy-efficient pharmaceutical manufacturing processes

Waste Reduction

Comprehensive pharmaceutical waste management protocols

ISO 14001

Environmental management system certified production

Sustainable Sourcing

Responsible procurement of pharmaceutical raw materials

Manufacturing Excellence & Quality Control

DRAVYOM's pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Donepezil Hydrochloride quality and neurological therapeutic performance.

GMP Production

Advanced pharmaceutical manufacturing in controlled clean-room environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive testing including assay, impurities, and stability

HPLC verification and pharmaceutical analysis
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and pharmaceutical validation
Pharmaceutical Packaging

Pharmaceutical-grade containers with moisture protection

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating Donepezil Hydrochloride effectiveness in cognitive enhancement applications with quantified performance metrics and clinical validation data.

Pharmaceutical Formulations
Bioavailability: 100% oral absorption Stability: 3-year shelf life validated Compatibility: Excellent with excipients
Therapeutic Applications
Cognitive Enhancement: Proven memory improvement Neurological: Established efficacy in dementia Safety: Well-tolerated neurological profile
Manufacturing Performance
Yield: 98% pharmaceutical grade recovery Purity: >99.8% pharmaceutical specification Consistency: 99.9% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Superior pharmaceutical grade quality with consistent neurological performance and regulatory compliance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical production scheduling

Formulation Expertise

Dedicated neurological pharmaceutical development team with specialized cognitive enhancement support

Regulatory Compliance

Complete pharmaceutical documentation with DMF support and international compliance

Global Standards

International pharmaceutical compliance with USP, EP, and ICH guidelines

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom development services