Tolvaptan USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Tolvaptan USP/EP

High-purity pharmaceutical grade Tolvaptan manufactured under stringent cGMP conditions. This vasopressin receptor antagonist API is essential for diuretic therapy, particularly in hyponatremia and heart failure treatment, providing reliable quality and regulatory compliance.

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

Chemical Formula: C26H25ClN2O3
CAS Number: 150683-30-0
Molecular Weight: 448.95 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.2%
Heavy Metals (as Pb): ≤20 ppm
Related Substances: ≤1.0% (total impurities)
Particle Size: D90 ≤ 100 μm
Melting Point: 235-245°C
Solubility: Practically insoluble in water
Storage Conditions: Store at room temperature, protect from light
Shelf Life: 3 years from date of manufacture
Packaging Options: 25g, 50g, 100g pharmaceutical containers

Applications

Cardiovascular Therapy
Oral Tablet Formulations
Diuretic Therapy
Vasopressin Antagonist
Hyponatremia Treatment
Heart Failure Management
Renal Function Support
Specialized Formulations
Cardiovascular Research
Pharmaceutical Manufacturing
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Tolvaptan grades tailored for specific cardiovascular pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse diuretic therapeutic applications.

USP Grade (United States Pharmacopeia)
Purity: ≥99.0% (HPLC) Related Substances: ≤1.0% Heavy Metals: ≤20 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (HPLC) Loss on Drying: ≤0.5% Melting Point: 235-245°C Application: EU regulatory submissions
Cardiovascular Grade
Purity: ≥99.5% (HPLC) Diuretic Activity: Verified Endotoxin: ≤0.25 EU/mg Application: Cardiovascular medications
Research Grade
Purity: ≥99.9% (HPLC) Characterization: Complete Stability: Documented Application: Research applications

Quality Standards

DRAVYOM's Tolvaptan is manufactured under stringent quality control protocols, meeting international pharmaceutical standards including USP, EP specifications. Our cardiovascular-grade production ensures consistent performance and regulatory compliance.

ISO 9001:2015 Certified Manufacturing
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Cardiovascular Testing
Diuretic Activity Verified
Batch-to-Batch Consistency
Comprehensive COA
Pharmaceutical Grade Packaging

Advanced Chemical Properties & Performance

Tolvaptan exhibits exceptional vasopressin V2 receptor antagonist properties essential for cardiovascular applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding diuretic formulations.

Molecular Properties
Molecular Weight: 448.94 g/mol
LogP: 4.4
pKa: No ionizable groups
Bioavailability: ~40%
Physical Properties
Melting Point: 185-190°C
Solubility (Water): 0.003 mg/mL
Crystalline Form: Crystalline free base
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
V2R Ki: 1.28 nM
V1A selectivity: 29-fold selective
Selectivity: V2 receptor selective
Stability: Stable in solid state
Purity Specifications
Assay: ≥99.0%
Related Substances: ≤0.5%
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Not light sensitive
Temperature Stability: Room temperature stable
pH Stability: Stable pH 1-12

Performance Characteristics

Detailed performance metrics demonstrate Tolvaptan superiority in cardiovascular applications with exceptional V2 receptor antagonism, bioavailability, and reproducibility across diverse diuretic formulations.

V2R Antagonism

Ki: 1.28 nM, 29-fold V1A selective

Highly selective diuretic action
Bioavailability

Oral: ~40% bioavailability

Reliable systemic exposure
Stability

Solid state: >3 years stability

Long-term pharmaceutical integrity
Thermal Stability

Working range: 15-30°C processing

Stable during formulation
Batch Reproducibility

Variation: ±0.5% between batches

Consistent lot-to-lot performance
Shelf Stability

3 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade cardiovascular API requiring careful handling. Handle with appropriate protective equipment in controlled environments. Avoid skin contact and inhalation. Follow cGMP guidelines for pharmaceutical 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 moisture. Keep containers tightly closed and protect from humidity. Use appropriate containment measures for pharmaceutical API handling.

Room temperature storage (15-25°C)
Protect from moisture
Original sealed containers
Pharmaceutical containment required

Chemical Mechanisms & Reaction Pathways

Tolvaptan functions as a selective vasopressin V2 receptor antagonist through competitive binding, preventing vasopressin-mediated water retention and enabling precise fluid balance management in cardiovascular conditions.

Receptor Antagonism

Selective competitive inhibition of vasopressin V2 receptors in renal collecting ducts

Blocks antidiuretic hormone action
Aquaporin-2 Inhibition

Prevents cAMP-mediated insertion of aquaporin-2 channels

Reduces water reabsorption effectively
Metabolic Pathways

Hepatic metabolism via CYP3A4 with multiple active metabolites

Extensive first-pass metabolism
Therapeutic Action

Aquaresis without electrolyte loss for fluid balance management

Improves serum sodium concentrations

Regulatory Compliance & Documentation

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

USP/EP Standards

United States Pharmacopeia and European Pharmacopoeia compliance

ICH Guidelines

International Conference on Harmonisation pharmaceutical standards

cGMP Manufacturing

Current Good Manufacturing Practice certified production

Global Registration

DMF filings and regulatory support for worldwide markets

Stability Studies

Long-term and accelerated stability data packages

Impurity Profiling

Comprehensive impurity identification and qualification

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, analytical method development, and regulatory assistance to optimize pharmaceutical manufacturing processes and ensure successful product development.

Formulation Development
  • API compatibility studies
  • Excipient interaction analysis
  • Stability-indicating method development
  • Formulation optimization support
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Forced degradation studies
  • Bioanalytical method development
Technical Support
  • Pharmaceutical development consultation
  • Manufacturing process optimization
  • Quality system implementation
  • Regulatory filing support
Supply Solutions
  • Clinical trial material supply
  • Commercial scale manufacturing
  • Just-in-time delivery programs
  • Global supply chain management

Environmental Impact & Sustainability

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

Green Chemistry

Optimized synthetic routes with minimal environmental impact

Solvent Recovery

Advanced solvent recovery and recycling systems

Energy Efficiency

Renewable energy integration in manufacturing processes

Waste Management

Comprehensive pharmaceutical waste treatment protocols

ISO 14001

Environmental management system certified operations

Packaging Innovation

Sustainable packaging materials and design optimization

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced process control technology and comprehensive quality systems to ensure consistent API quality and performance across all production batches.

cGMP Manufacturing

Current Good Manufacturing Practice compliant production in controlled environments

FDA and EMA inspected pharmaceutical facilities
Quality Control

Multi-point quality control testing including assay, related substances, and residual solvents

HPLC, GC-MS, and NMR analytical verification
Quality Systems

ISO 9001:2015 quality management with pharmaceutical quality system standards

Continuous improvement and change control procedures
Packaging Systems

Primary packaging in controlled atmosphere with tamper-evident sealing

Light protection and moisture barrier packaging

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating API effectiveness across diverse therapeutic applications with quantified performance metrics and regulatory validation studies.

Pharmaceutical Manufacturing
Purity: >99.5% pharmaceutical grade Stability: 36-month shelf life data Compliance: 100% regulatory specifications
Research & Development
Research Support: 200+ published studies Method Validation: Cross-platform verification Innovation: Advanced analytical techniques
Clinical Applications
Clinical Grade: Phase I-III trial supply Regulatory Success: Global market approvals Manufacturing: Scalable production processes

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds USP/EP specifications with exceptional purity and pharmaceutical performance standards

Reliable Supply Chain

Guaranteed pharmaceutical-grade availability with strategic inventory management and production scheduling

Development Expertise

Dedicated pharmaceutical development team provides formulation and analytical method support

Regulatory Excellence

Comprehensive documentation packages with global regulatory filing support and validation

Global Standards

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

Partnership Excellence

Collaborative pharmaceutical development relationships with custom API synthesis and scale-up services