Tianeptine Sodium Salt USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Tianeptine Sodium Salt USP/EP

High-purity pharmaceutical grade Tianeptine Sodium Salt manufactured under stringent cGMP conditions. This tricyclic antidepressant API is essential for treating depression and anxiety disorders, providing reliable quality and regulatory compliance for mental health therapeutics.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥99.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Tricyclic Antidepressant for Mental Health
  • Regulatory Compliance Ready
Request Quote Technical Support

Technical Specifications

Chemical Formula: C21H24ClN2NaO4S
CAS Number: 30123-17-2
Molecular Weight: 458.94 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
pH (1% solution): 6.0-8.0
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, 50g, 100g pharmaceutical containers

Applications

Oral Tablet Formulations
Capsule Formulations
Depression Treatment
Anxiety Disorders
CNS Research
Psychiatry Units
Mental Health Therapy
Antidepressant Formulations
Neuropharmacology
Clinical Trials
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Tianeptine Sodium Salt grades tailored for specific CNS pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse mental health 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) pH: 6.0-8.0 (1% solution) Loss on Drying: ≤0.5% Application: EU regulatory submissions
CNS Research Grade
Purity: ≥99.5% (HPLC) Water Content: ≤0.2% Residue on Ignition: ≤0.05% Application: Neuropharmacology research
Reference Standard Grade
Purity: ≥99.8% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

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

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

Advanced Chemical Properties & Performance

Pharmaceutical Grade Tianeptine Sodium Salt exhibits exceptional chemical properties essential for CNS applications. Its tricyclic antidepressant composition and precise specification ensure reliable performance in demanding pharmaceutical formulations and neuropharmacological systems.

Chemical Properties
Molecular Formula: C₂₁H₂₄ClN₂O₄S·Na
Molecular Weight: 458.93 g/mol
Melting Point: 184-188°C
LogP (Octanol/Water): 3.2
Physical Properties
Appearance: White to off-white crystalline powder
Solubility: Freely soluble in water
pH (1% solution): 5.5-7.0
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Bioavailability: 99% (oral)
Half-life: 2.5-3 hours
Protein Binding: 94%
Mechanism: Serotonin reuptake enhancer
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: Light sensitive (store protected)
Temperature Stability: Stable 15-25°C
Humidity Stability: Store ≤60% RH

Performance Characteristics

Detailed performance metrics demonstrate Pharmaceutical Grade Tianeptine Sodium Salt superiority in CNS applications with exceptional functionality, stability, and reproducibility across diverse pharmaceutical procedures and neuropsychiatric protocols.

CNS Efficacy

Potency: Unique serotonin reuptake enhancer

Superior antidepressant activity
Onset of Action

Time: 1-2 weeks for full therapeutic effect

Rapid mood stabilization
Bioavailability

Absorption: 99% oral bioavailability

Excellent 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 clinical use. CNS active agent requiring careful monitoring and dose titration. Handle with standard laboratory precautions including appropriate protective equipment. Avoid inhalation of powder and ensure proper ventilation during processing.

Prescription Only
CNS 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)
Protect from light
Original sealed containers

Chemical Mechanisms & Reaction Pathways

Pharmaceutical Grade Tianeptine Sodium Salt exhibits unique tricyclic antidepressant properties through serotonin reuptake enhancement enabling effective mood disorder treatment with distinctive neurochemical mechanisms and therapeutic characteristics.

Serotonin Enhancement

Selective enhancement of serotonin reuptake in neurons

Unique mechanism opposite to conventional SSRIs
Neuroplasticity

Promotes synaptic plasticity and neuronal adaptation

Supports long-term therapeutic neurological changes
AMPA Modulation

Modulation of AMPA receptor function for neuroprotection

Prevents stress-induced neuronal damage
HPA Axis

Normalization of hypothalamic-pituitary-adrenal axis

Reduces stress hormone dysregulation

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia API standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical manufacturing

Neuropsychiatric Approval

Approved antidepressant API with comprehensive safety profiles

International Standards

Global regulatory compliance for neuropsychiatric applications

DMF Documentation

Drug Master File with comprehensive manufacturing and safety data

cGMP Certified

Current Good Manufacturing Practice with neuropsychiatric API standards

Technical Support & Value-Added Services

DRAVYOM's neuropsychiatric API team provides comprehensive development support, formulation optimization assistance, and regulatory services for antidepressant drug manufacturing with specialized CNS expertise.

API Development
  • CNS formulation support
  • Bioavailability enhancement studies
  • Stability optimization protocols
  • Extended-release development
Analytical Services
  • Certificate of Analysis with CNS-specific testing
  • Polymorphic form characterization
  • Impurity profiling and identification
  • Dissolution study support
Regulatory Support
  • Neuropsychiatric 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 Tianeptine Sodium Salt 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 neuropsychiatric API manufacturing facility employs advanced synthetic technology and continuous monitoring systems to ensure consistent Pharmaceutical Grade Tianeptine Sodium Salt quality and therapeutic efficacy.

Production Process

Advanced multi-step synthesis with pharmaceutical-grade intermediates

Controlled synthesis for optimal purity and yield
Quality Testing

28-point pharmaceutical testing protocol including polymorphic analysis

HPLC verification and CNS-specific testing
Quality Systems

cGMP compliance with neuropsychiatric API manufacturing standards

Continuous improvement 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 Tianeptine Sodium Salt effectiveness across diverse neuropsychiatric applications with quantified therapeutic metrics and safety profiles.

Depression Treatment
Efficacy: 65-75% response rate Onset: 2-4 weeks therapeutic effect Duration: Long-term mood stabilization
Anxiety Disorders
Anxiolytic: Reduced anxiety symptoms Cognition: Improved cognitive function Adaptation: Enhanced stress resilience
Neuroplasticity
Neuroprotection: Prevents stress-induced damage Plasticity: Enhanced synaptic adaptability Recovery: Improved neurological recovery

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmacopeial specifications with optimal polymorphic control and impurity profile

Reliable Supply

Guaranteed availability with strategic inventory management and neuropsychiatric API expertise

API Expertise

Specialized neuropsychiatric API manufacturing with comprehensive development support

Quality Assurance

Enhanced testing protocols with complete documentation and regulatory compliance

Global Standards

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

Partnership Approach

Collaborative relationships with CNS pharmaceutical companies and development support