Memantine Hydrochloride
Pharmaceutical Premium
Pharmaceutical API

Memantine Hydrochloride

High-purity pharmaceutical grade Memantine Hydrochloride 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: C12H21N·HCl
CAS Number: 41100-52-1
EINECS Number: 255-209-1
Molecular Weight: 215.76 g/mol
Physical State: White crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Melting Point: 295-300°C (decomposes)
pH (1% solution): 4.0-6.0
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, 100g, 500g pharmaceutical containers

Applications

Alzheimer's Disease Treatment
Dementia Therapy
NMDA Receptor Antagonist
Neuroprotective Research
Neuroscience Research
Neurological Hospitals
Pharmaceutical Manufacturing
Cognitive Enhancement
Neurodegeneration Research
Clinical Trials
Regulatory Submissions
Reference Standards

Industry-Specific Grades

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

Quality Standards

DRAVYOM's Memantine Hydrochloride 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

Memantine Hydrochloride exhibits exceptional pharmaceutical properties essential for Alzheimer's disease treatment applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and neurological therapies.

Pharmaceutical Properties
Molecular Weight: 215.76 g/mol
Solubility (Water): Freely soluble
Partition Coefficient: LogP = 3.3
Bioavailability: ≥100% oral absorption
Physical Properties
Melting Point: 259-261°C
Appearance: White crystalline powder
Crystalline Form: Stable polymorphic form
Bulk Density: 0.40-0.60 g/mL
Formulation Performance
Dissolution Rate: ≥85% in 30 minutes
Tablet Hardness: 4-8 kp compatible
Compressibility: Good 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: Stable to light
Temperature Stability: Stable 15-30°C
Humidity Sensitivity: Store below 65% RH

Performance Characteristics

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

Therapeutic Performance

Bioavailability: ≥100% oral absorption

Excellent neuroprotective efficacy
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: ±1.0% between batches

Exceptional lot-to-lot consistency
Processing Performance

Compressibility: Good 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 (≤65% RH)
Protect from contamination
Complete documentation required

Chemical Mechanisms & Reaction Pathways

Memantine Hydrochloride exhibits unique neuroprotective activity through NMDA receptor antagonism and glutamate modulation pathways, enabling precise neurological applications with memory enhancement and neuroprotective characteristics.

NMDA Receptor Antagonism

Low-affinity, voltage-dependent, uncompetitive NMDA receptor blocker

Prevents excessive glutamate-induced neurotoxicity
Glutamate Modulation

Normalizes pathological glutamate signaling while preserving physiological function

Maintains synaptic plasticity and learning
Neuroprotection

Protects against oxidative stress and calcium-mediated cell death

Preserves neuronal integrity and function
Blood-Brain Barrier

Excellent CNS penetration with predictable pharmacokinetics

Optimal brain exposure for therapeutic effect

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia neurological pharmaceutical grade standards compliance

EP Standards

European Pharmacopoeia specifications for CNS pharmaceutical manufacturing

cGMP Manufacturing

Current Good Manufacturing Practice certified neurological API production

ICH Guidelines

International Conference on Harmonisation neurological quality standards

DMF Support

Drug Master File documentation for neurological regulatory submissions

Quality Documentation

Complete neurological API documentation package with stability data

Technical Support & Value-Added Services

DRAVYOM's neurological pharmaceutical development team provides comprehensive formulation support, CNS drug development guidance, and regulatory support to optimize Memantine Hydrochloride performance in neurological applications.

Formulation Development
  • CNS dosage form optimization
  • Extended release formulation design
  • Bioavailability enhancement strategies
  • Taste masking for oral formulations
Analytical Services
  • Certificate of Analysis verification
  • Neurological API impurity profiling
  • CNS-specific method validation
  • Stability testing programs
Technical Support
  • CNS pharmaceutical troubleshooting
  • cGMP compliance for neurological APIs
  • Process optimization support
  • Regulatory documentation assistance
Supply Solutions
  • Consistent neurological grade scheduling
  • Emergency CNS API supply
  • Custom packaging solutions
  • Global pharmaceutical distribution

Environmental Impact & Sustainability

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

Waste Minimization

Optimized synthesis with minimal neurological pharmaceutical waste generation

Water Treatment

Advanced pharmaceutical wastewater treatment and recycling systems

Green Chemistry

Environmentally conscious neurological API synthesis with emission controls

Safe Disposal

Comprehensive guidance for neurological pharmaceutical waste management

ISO 14001

Environmental management system certified pharmaceutical production

Carbon Footprint

Reduced carbon footprint through neurological API process optimization

Manufacturing Excellence & Quality Control

DRAVYOM's specialized neurological pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Memantine Hydrochloride quality and performance across all production batches.

Production Process

Advanced synthesis and purification in controlled neurological API environment

Multi-stage crystallization for pharmaceutical grade CNS quality
Quality Testing

Comprehensive analytical testing including neurological API related substances

HPLC verification and CNS-specific analysis
Quality Systems

ISO 9001:2015 quality management with neurological pharmaceutical accreditation

Specialized CNS API quality systems
Packaging Control

Pharmaceutical-grade containers with neurological API protection

Moisture control and stability preservation

Market Applications & Performance Data

Comprehensive neurological pharmaceutical development data demonstrating Memantine Hydrochloride effectiveness across diverse therapeutic applications with quantified performance metrics and CNS development validations.

CNS Manufacturing
Bioavailability: >95% oral absorption Stability: 5+ years shelf life Purity: >99.5% neurological grade
Clinical Applications
Efficacy: Proven Alzheimer's treatment Safety: Well-established neurological profile Regulatory: Multiple CNS approvals
Manufacturing Scale
Capacity: Multi-ton annual neurological production Consistency: <0.1% batch-to-batch variation Compliance: 100% neurological cGMP adherence

DRAVYOM Competitive Advantages

CNS Expertise

Specialized neurological manufacturing with ultra-low impurities and exceptional CNS pharmaceutical performance

Reliable Supply

Guaranteed availability with neurological inventory management and CNS-grade production scheduling

Neurological Expertise

Dedicated CNS pharmaceutical development team with neurological formulation expertise

Quality Assurance

Comprehensive certificates with complete analytical data and neurological documentation

Global Standards

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

Partnership Approach

Collaborative relationships with neurological pharmaceutical companies and custom CNS API development