Valsartan
Pharmaceutical Premium
Pharmaceutical API

Valsartan

High-purity pharmaceutical grade Valsartan 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: C24H29N5O3
CAS Number: 137862-53-4
Molecular Weight: 435.52 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: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% (total impurities)
Particle Size: D90 ≤ 100 μm
pH (1% solution): 5.5-7.5
Solubility: Sparingly soluble 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

Hypertension Treatment
Oral Tablet Formulations
Capsule Formulations
Cardiovascular Therapy
ARB Medications
Blood Pressure Control
Antihypertensive Drugs
Angiotensin Receptor Blocker
Cardiovascular Research
Generic Formulations
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Valsartan grades tailored for specific cardiovascular pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse antihypertensive therapeutic 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) Loss on Drying: ≤0.5% pH: 5.5-7.5 (1% solution) Application: EU regulatory submissions
Antihypertensive Grade
Purity: ≥99.5% (HPLC) ARB Activity: Verified Bioavailability: Optimized Application: Cardiovascular medications
Generic Grade
Purity: ≥99.8% (HPLC) Dissolution Profile: Matched Stability: Verified Application: Generic formulations

Quality Standards

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

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

Advanced Chemical Properties & Performance

Pharmaceutical Grade Valsartan exhibits exceptional chemical properties essential for hypertension applications. Its angiotensin receptor blocker composition and precise specification ensure reliable performance in demanding pharmaceutical formulations and cardiovascular treatment systems.

Chemical Properties
Molecular Formula: C₂₄H₂₉N₅O₃
Molecular Weight: 435.52 g/mol
Melting Point: 116-117°C
LogP (Octanol/Water): 4.4
Physical Properties
Appearance: White to off-white crystalline powder
Solubility: Practically insoluble in water
pH (saturated solution): 7.0-8.0
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Bioavailability: 23% (oral)
Half-life: 6 hours
Protein Binding: 95%
Mechanism: AT₁ receptor antagonist
Purity Specifications
Assay (HPLC): ≥ 99.0%
Related Substances: ≤ 0.5%
Heavy Metals: ≤ 20 ppm
Residual Solvents: Within ICH limits
Stability Properties
Shelf Life: 3 years (unopened)
Photostability: Stable under normal light
Temperature Stability: Stable 15-25°C
Humidity Stability: Store ≤60% RH

Performance Characteristics

Detailed performance metrics demonstrate Pharmaceutical Grade Valsartan superiority in antihypertensive applications with exceptional functionality, stability, and reproducibility across diverse pharmaceutical procedures and cardiovascular protocols.

Antihypertensive Efficacy

Potency: Selective AT₁ receptor antagonist

Superior blood pressure control
Duration of Action

Time: 24-hour therapeutic effect

Once-daily dosing convenience
Bioavailability

Absorption: 23% oral bioavailability

Predictable therapeutic levels
Formulation Stability

Range: Stable in standard formulations

Consistent performance across dosage forms
Batch Uniformity

Variation: ±0.5% between production batches

Exceptional pharmaceutical grade consistency
Long-term Stability

3 years shelf life with maintained potency

Extended pharmaceutical grade integrity

Safety Information

Prescription pharmaceutical with established safety profile in cardiovascular therapy. Generally well-tolerated antihypertensive agent requiring blood pressure monitoring. Handle with standard laboratory precautions including appropriate protective equipment. Avoid inhalation of powder and ensure proper ventilation during processing.

Prescription Only
Cardiovascular Active
Medical Supervision

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 degradation. Use appropriate pharmaceutical handling procedures and ensure proper environmental controls for stability management.

Cool storage (15-25°C)
Low humidity (≤60% RH)
Normal light exposure acceptable
Original sealed containers

Chemical Mechanisms & Reaction Pathways

Pharmaceutical Grade Valsartan exhibits selective angiotensin II receptor antagonist properties through tetrazole biphenyl structure enabling effective blood pressure control with cardiovascular protection and minimal metabolic side effects.

AT1 Receptor Blockade

Selective antagonism of angiotensin II type 1 receptors

Primary mechanism for blood pressure reduction
Cardiovascular Protection

Prevents angiotensin II-mediated vasoconstriction and aldosterone release

Long-term cardiovascular and renal benefits
Vascular Remodeling

Inhibition of vascular smooth muscle proliferation

Prevents arterial wall thickening and stiffening
Metabolic Neutrality

No adverse effects on glucose or lipid metabolism

Suitable for diabetic and metabolic syndrome patients

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical market access with complete API documentation supporting international standards and cardiovascular drug manufacturing validations.

USP Specifications

United States Pharmacopeia API standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical manufacturing

FDA Approved

FDA approved antihypertensive API with comprehensive safety data

EMA Approval

European Medicines Agency approval for cardiovascular applications

DMF Documentation

Drug Master File with comprehensive manufacturing and safety data

cGMP Certified

Current Good Manufacturing Practice with cardiovascular API standards

Technical Support & Value-Added Services

DRAVYOM's cardiovascular API team provides comprehensive development support, formulation optimization assistance, and regulatory services for antihypertensive drug manufacturing with specialized cardiology expertise.

API Development
  • Cardiovascular formulation support
  • Bioavailability enhancement studies
  • Stability optimization protocols
  • Fixed-dose combination development
Analytical Services
  • Certificate of Analysis with cardiovascular testing
  • Polymorphic form characterization
  • Impurity profiling and identification
  • Dissolution study support
Regulatory Support
  • Cardiovascular drug documentation
  • Regulatory filing assistance
  • Clinical trial support
  • Post-market surveillance
Supply Solutions
  • Consistent API supply chains
  • Temperature-controlled logistics
  • Emergency supply protocols
  • Global distribution network

Environmental Impact & Sustainability

Our Pharmaceutical Grade Valsartan production emphasizes environmental responsibility through green chemistry principles, sustainable synthetic pathways, and comprehensive environmental impact management for API manufacturing.

Green Synthesis

Optimized synthetic routes with minimal environmental impact

Solvent Recovery

Advanced solvent recycling and waste minimization

Clean Production

Energy-efficient synthesis with emission controls

Water Treatment

Advanced wastewater treatment and recycling systems

ISO 14001

Environmental management system certified production

Carbon Reduction

Continuous carbon footprint reduction initiatives

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art cardiovascular API manufacturing facility employs advanced synthetic technology and continuous monitoring systems to ensure consistent Pharmaceutical Grade Valsartan quality and therapeutic efficacy.

Production Process

Advanced multi-step synthesis with pharmaceutical-grade intermediates

Controlled synthesis for optimal purity and yield
Quality Testing

26-point pharmaceutical testing protocol including NDMA analysis

HPLC verification and cardiovascular-specific testing
Quality Systems

cGMP compliance with cardiovascular API manufacturing standards

Enhanced nitrosamine control and process validation
API Packaging

Specialized packaging with moisture and light protection

Stability maintenance and contamination prevention

Market Applications & Performance Data

Comprehensive clinical and pharmaceutical data demonstrating Pharmaceutical Grade Valsartan effectiveness across diverse cardiovascular applications with quantified therapeutic metrics and safety profiles.

Hypertension
BP Reduction: 10-15 mmHg systolic reduction Response Rate: 60-80% of patients achieve targets Duration: 24-hour blood pressure control
Heart Failure
Mortality: 13% reduction in cardiovascular death Hospitalization: 27% reduction in heart failure events Quality of Life: Improved functional capacity
Post-MI Protection
Survival: Improved long-term survival Remodeling: Reduced left ventricular enlargement Combination: Synergistic with ACE inhibitors

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmacopeial specifications with optimal polymorphic control and nitrosamine-free profile

Reliable Supply

Guaranteed availability with strategic inventory management and cardiovascular API expertise

API Expertise

Specialized cardiovascular API manufacturing with comprehensive ARB development support

Quality Assurance

Enhanced testing protocols with complete documentation and regulatory compliance

Global Standards

International compliance with USP, EP, and cardiovascular drug regulations worldwide

Partnership Approach

Collaborative relationships with cardiovascular pharmaceutical companies and development support