Name: Treprostinil Olamine | Pharmaceutical Grade API
Brand: DRAVYOM
SKU: DTRO-PH-001

Technical Specifications

Chemical Formula: C23H34O5·C2H7NO

CAS Number: 289480-64-4

Molecular Weight: 451.57 g/mol

Physical State: White to off-white crystalline powder

Purity (HPLC): ≥99.5% (USP/EP Grade)

pH (1% solution): 8.0-10.0

Loss on Drying: ≤0.5%

Residue on Ignition: ≤0.1%

Heavy Metals (as Pb): ≤10 ppm

Related Substances: ≤0.5% (total impurities)

Storage Conditions: Store at 2-8°C, protect from light

Shelf Life: 3 years from date of manufacture

Packaging Options: 25g, 50g, 100g pharmaceutical containers

Applications

Oral Tablet Formulations

Injectable Formulations

Pulmonary Hypertension

Cardiovascular Applications

Prostacyclin Research

Cardiology Units

Vasodilator Therapy

PAH Treatment

Vascular Research

Clinical Trials

Regulatory Submissions

Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Treprostinil Olamine grades tailored for specific cardiovascular pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse pulmonary hypertension therapeutic applications.

USP Grade (United States Pharmacopeia)

Purity: ≥99.5% (HPLC) Related Substances: ≤0.5% Heavy Metals: ≤10 ppm Application: FDA-compliant formulations

EP Grade (European Pharmacopoeia)

Purity: ≥99.5% (HPLC) pH: 8.0-10.0 (1% solution) Loss on Drying: ≤0.5% Application: EU regulatory submissions

Pulmonary Research Grade

Purity: ≥99.8% (HPLC) Water Content: ≤0.2% Residue on Ignition: ≤0.05% Application: PAH research

Reference Standard Grade

Purity: ≥99.9% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

DRAVYOM's Treprostinil Olamine 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

≥99.5% HPLC Purity

Advanced Cardiovascular Testing

Pulmonary Grade Quality

Batch-to-Batch Consistency

Comprehensive COA

Cold Chain Storage

Advanced Chemical Properties & Performance

Pharmaceutical Grade Treprostinil Olamine exhibits exceptional chemical properties essential for pulmonary hypertension applications. Its prostacyclin analog composition and precise specification ensure reliable performance in demanding pharmaceutical formulations and cardiovascular treatment systems.

Chemical Properties

Molecular Formula: C₂₅H₃₄O₇N

Molecular Weight: 475.54 g/mol

Melting Point: 94-98°C

LogP (Octanol/Water): 4.2

Physical Properties

Appearance: White to off-white crystalline powder

Solubility: Freely soluble in water

pH (1% solution): 8.0-9.5

Hygroscopicity: Slightly hygroscopic

Pharmaceutical Performance

Bioavailability: 17% (oral)

Half-life: 4.4 hours

Protein Binding: 91%

Mechanism: Prostacyclin receptor agonist

Purity Specifications

Assay (HPLC): ≥ 99.5%

Related Substances: ≤ 0.3%

Heavy Metals: ≤ 20 ppm

Residual Solvents: Within ICH limits

Stability Properties

Shelf Life: 2 years (unopened, refrigerated)

Photostability: Light sensitive (store protected)

Temperature Stability: Store 2-8°C

Humidity Stability: Store ≤60% RH

Performance Characteristics

Detailed performance metrics demonstrate Pharmaceutical Grade Treprostinil Olamine superiority in pulmonary hypertension applications with exceptional functionality, stability, and reproducibility across diverse pharmaceutical procedures and cardiovascular protocols.

Pulmonary Efficacy

Potency: Selective prostacyclin receptor agonist

Superior pulmonary vasodilation

Duration of Action

Time: 4.4 hour half-life

Sustained therapeutic effect

Bioavailability

Absorption: 17% oral bioavailability

Predictable therapeutic levels

Formulation Stability

Range: Stable in refrigerated conditions

Maintained potency under cold storage

Batch Uniformity

Variation: ±0.3% between production batches

Exceptional pharmaceutical grade consistency

Long-term Stability

2 years shelf life with cold chain

Extended pharmaceutical grade integrity

Safety Information

Prescription pharmaceutical for specialized pulmonary hypertension therapy. Requires careful dose titration and monitoring. Handle with standard laboratory precautions including appropriate protective equipment. Store under refrigerated conditions and protect from light. Avoid inhalation of powder and ensure proper ventilation during processing.

Prescription Only

Refrigerated Storage

Specialist Supervision

Storage & Handling

Store in original sealed containers in refrigerated conditions (2-8°C) in a well-ventilated area away from light and moisture. Keep containers tightly closed and protect from degradation. Use appropriate pharmaceutical handling procedures with cold chain management and ensure proper environmental controls for stability.

Refrigerated storage (2-8°C)

Low humidity (≤60% RH)

Protect from light

Cold chain logistics required

Chemical Mechanisms & Reaction Pathways

Pharmaceutical Grade Treprostinil Olamine exhibits potent prostacyclin analog properties through tricyclic benzindene structure enabling effective pulmonary arterial hypertension treatment with multiple receptor targets and vasodilatory mechanisms.

Prostacyclin Agonism

Direct prostacyclin receptor activation with potent vasodilation

Primary mechanism for pulmonary vascular remodeling

Antiplatelet Action

Inhibition of platelet aggregation and thrombosis

Prevents microvascular thrombotic complications

Endothelial Protection

Preservation of endothelial function and nitric oxide signaling

Long-term vascular protective benefits

Hemodynamic Benefits

Sustained reduction in pulmonary vascular resistance

Improved cardiac output and functional capacity

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia API standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical manufacturing

FDA Approved

FDA approved pulmonary hypertension API with comprehensive safety data

EMA Approval

European Medicines Agency approval for PAH 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 pulmonary hypertension drug manufacturing with specialized expertise.

API Development

PAH formulation support
Bioavailability enhancement studies
Stability optimization protocols
Sustained-release development

Analytical Services

Certificate of Analysis with cardiovascular testing
Polymorphic form characterization
Impurity profiling and identification
Dissolution study support

Regulatory Support

PAH 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 Treprostinil Olamine 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 Neutral

Carbon-neutral production with renewable energy

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 Treprostinil Olamine quality and therapeutic efficacy.

Production Process

Advanced multi-step synthesis with pharmaceutical-grade intermediates

Controlled synthesis for optimal purity and yield

Quality Testing

33-point pharmaceutical testing protocol including stereochemical analysis

HPLC verification and cardiovascular-specific testing

Quality Systems

cGMP compliance with cardiovascular API manufacturing standards

Continuous improvement and process validation

API Packaging

Specialized packaging with inert atmosphere protection

Stability maintenance and oxidation prevention

Market Applications & Performance Data

Comprehensive clinical and pharmaceutical data demonstrating Pharmaceutical Grade Treprostinil Olamine effectiveness across diverse PAH applications with quantified therapeutic metrics and hemodynamic improvements.

Pulmonary Arterial Hypertension

6MWD: 20-40m improvement in walking distance Hemodynamics: Significant PVR reduction WHO Class: Functional class improvement

Long-term Benefits

Survival: Improved long-term outcomes Hospitalization: Reduced PAH-related admissions Quality of Life: Enhanced functional capacity

Combination Therapy

ERA Combinations: Synergistic vasodilation PDE5i Combinations: Enhanced efficacy Triple Therapy: Maximum therapeutic benefit

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmacopeial specifications with optimal stereochemical control and impurity profile

Reliable Supply

Guaranteed availability with strategic inventory management and PAH API expertise

API Expertise

Specialized cardiovascular API manufacturing with comprehensive PAH development support

Quality Assurance

Enhanced testing protocols with complete documentation and regulatory compliance

Global Standards

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

Partnership Approach

Collaborative relationships with cardiovascular pharmaceutical companies and development support

Treprostinil Olamine