Rivastigmine Hydrogen Tartrate Pharmaceutical API
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Pharmaceutical API

Rivastigmine Hydrogen Tartrate

High-purity pharmaceutical grade Rivastigmine Hydrogen Tartrate API manufactured to meet stringent USP/EP specifications for Alzheimer's disease medication production. Our pharmaceutical-grade Rivastigmine Hydrogen Tartrate delivers exceptional quality and consistency for critical pharmaceutical applications.

  • USP/EP Compliant Grade
  • High Purity (>99.5%)
  • Cholinesterase Inhibitor
  • GMP Certified Manufacturing
  • Reliable Supply Chain
  • Complete Documentation
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Technical Specifications

Chemical Formula: C14H22N2O2·C4H6O6
CAS Number: 129101-54-8
EINECS Number: Not applicable
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to off-white crystalline powder
Molecular Weight: 400.43 g/mol
Melting Point: 142-146°C
pH (1% solution): 3.5-4.5
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: 100g, 500g, 1kg containers

Applications

Alzheimer's Disease
Dementia Treatment
Oral Tablet Formulations
Extended-Release Capsules
Cholinesterase Inhibitor
Transdermal Patches
Cognitive Enhancement
Neurodegenerative Diseases
Neurological Research
Clinical Trials
CNS Drug Development
Pharmaceutical Research

Industry-Specific Grades

DRAVYOM offers specialized Rivastigmine Hydrogen Tartrate grades tailored for specific neurological applications, ensuring optimal cholinesterase inhibitor 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
Transdermal Grade
Purity: ≥99.5% Permeability: Optimized Stability: Enhanced Application: Patch formulations

Quality Standards

DRAVYOM's Rivastigmine Hydrogen Tartrate 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
Cholinesterase Activity Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Controlled Storage & Shipping

Advanced Chemical Properties & Performance

Rivastigmine Hydrogen Tartrate exhibits exceptional cholinesterase inhibitor properties essential for neurological applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding Alzheimer's disease formulations.

Molecular Properties
Molecular Weight: 400.43 g/mol
LogP: 1.8
pKa: 8.2
Bioavailability: 64%
Physical Properties
Melting Point: 123-125°C
Solubility (Water): >50 mg/mL
Crystalline Form: Stable polymorph
Hygroscopicity: Slightly hygroscopic
Pharmacological Performance
AChE IC50: 4.15 μM
BuChE IC50: 1.15 μM
Selectivity: Dual cholinesterase inhibitor
Brain Penetration: Excellent CNS access
Purity Specifications
Assay: ≥99.0%
Related Substances: ≤0.5%
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Stable at room temperature
pH Stability: Stable pH 4-8

Performance Characteristics

Detailed performance metrics demonstrate Rivastigmine Hydrogen Tartrate superiority in neurological applications with exceptional cholinesterase inhibition, brain penetration, and reproducibility across diverse Alzheimer's disease formulations.

ChE Inhibition

IC50: 1.15-4.15 μM dual inhibition

Potent cholinesterase inhibition
Brain Penetration

CNS: Excellent brain-blood barrier crossing

Superior neurological access
Bioavailability

Oral: 64% absolute bioavailability

Good systemic exposure
Thermal Stability

Working range: 15-40°C processing

Stable during formulation
Batch Reproducibility

Variation: ±0.5% between batches

Consistent lot-to-lot performance
Shelf Stability

5 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical API requiring specialized handling. Handle with appropriate protective equipment in controlled environments. Avoid skin contact and inhalation. Follow cGMP guidelines for neurological APIs and ensure proper waste disposal procedures.

Pharmaceutical API
Avoid Skin Contact
Avoid Inhalation

Storage & Handling

Store in original sealed containers in a cool, dry, well-ventilated area away from light and moisture. Keep containers tightly closed and protect from direct sunlight. Use appropriate handling measures for pharmaceutical APIs.

Cool storage (15-25°C)
Protect from light
Original sealed containers
Low humidity environment

Chemical Mechanisms & Reaction Pathways

Rivastigmine Hydrogen Tartrate exhibits specific acetylcholinesterase inhibitor mechanisms essential for Alzheimer's disease treatment. Its molecular structure enables selective enzyme inhibition with predictable cognitive enhancement therapeutic responses.

Cholinesterase Inhibition

Pseudo-irreversible acetylcholinesterase and butyrylcholinesterase inhibition

Cognitive function enhancement
Metabolic Pathways

Hepatic metabolism via cholinesterase-mediated hydrolysis

Target-mediated clearance
CNS Selectivity

Preferential brain acetylcholinesterase targeting

Targeted neurological action
Pharmacological Effects

Cholinergic enhancement and neuroprotective properties

Dementia symptom improvement

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia pharmaceutical standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical quality

ICH Guidelines

International Conference on Harmonization standards compliance

GMP Certification

Good Manufacturing Practices certified production facility

DMF Support

Drug Master File documentation for regulatory submissions

CEP Available

Certificate of Suitability to European Pharmacopoeia monographs

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, regulatory assistance, and technical services to optimize pharmaceutical performance in your specific drug development applications.

Formulation Development
  • Dosage form optimization support
  • Stability testing guidance
  • Bioavailability enhancement
  • Custom formulation development
Analytical Services
  • Method development and validation
  • Impurity profiling and identification
  • Stability indicating methods
  • Dissolution testing support
Regulatory Support
  • Regulatory submission assistance
  • DMF preparation and maintenance
  • Pharmacovigilance support
  • Global registration strategy
Supply Solutions
  • Pharmaceutical supply chain management
  • Cold chain logistics
  • Custom packaging solutions
  • Global distribution network

Environmental Impact & Sustainability

Our pharmaceutical production emphasizes environmental responsibility through sustainable manufacturing practices, green chemistry principles, and comprehensive environmental impact management for pharmaceutical operations.

Green Chemistry

Sustainable synthetic routes with minimal environmental impact

Water Management

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive pharmaceutical waste management protocols

ISO 14001

Environmental management system certified production

Sustainable Packaging

Recyclable pharmaceutical packaging solutions

Manufacturing Excellence & Quality Control

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

Production Process

Advanced synthesis and purification in GMP-controlled clean-room environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive testing protocol including purity, potency, and impurity profiling

HPLC, GC-MS, and spectroscopic analysis
Quality Systems

ISO 9001:2015 and GMP quality management systems

Continuous improvement and validation protocols
Packaging Control

Pharmaceutical-grade packaging with controlled atmosphere

Contamination prevention and stability protection

Market Applications & Performance Data

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

Pharmaceutical Development
Formulation Success: 95+ formulations developed Regulatory Approvals: 100+ successful submissions Quality Consistency: 99.9% batch compliance
Research Applications
Clinical Studies: 200+ supported trials Publication Support: 150+ peer-reviewed papers Innovation: Custom API development
Commercial Manufacturing
Scale-up Success: 100% process transfers Supply Reliability: 99.8% on-time delivery Cost Optimization: 25% average cost reduction

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds pharmacopeial specifications with superior purity and pharmaceutical performance

Reliable Supply

Guaranteed pharmaceutical availability with strategic inventory and GMP production scheduling

Development Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Regulatory Assurance

Complete regulatory packages with DMF support and global registration assistance

Global Standards

International compliance with USP, EP, and ICH standards for worldwide market access

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services