Tianeptine Sodium API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Tianeptine Sodium API is the sodium salt of Tianeptine, a tricyclic compound used as an antidepressant in certain markets. The pharmaceutical substance is chemically classified as a tricyclic antidepressant and is characterized by its sodium salt form. The commonly referenced API has CAS No. 30123-17-2, molecular formula C₂₁H₂₄ClN₂NaO₄S, and molecular weight 458.9 g/mol.

Tianeptine Sodium is described in the British Pharmacopoeia 2025 / Ph. Eur. 11.6 update with a content requirement of 99.0%–101.0% on the anhydrous substance. It is described as a white or yellowish, very hygroscopic powder and is freely soluble in water, methanol and methylene chloride.

Swapnroop Drugs & Pharmaceuticals focuses on quality-oriented Tianeptine Sodium API manufacturing in India, supporting authorized pharmaceutical customers with API quality, analytical testing and documentation requirements.

About Tianeptine Sodium API

Tianeptine Sodium is the sodium salt of Tianeptine. It contains a tricyclic benzothiazepine-related structure with a heptanoic acid sodium salt functionality and sulfur dioxide group.

Key Product Information

  • Product Name: Tianeptine Sodium
  • CAS No.: 30123-17-2
  • Molecular Formula: C₂₁H₂₄ClN₂NaO₄S
  • Molecular Weight: 458.9 g/mol
  • Chemical Category: Tricyclic antidepressant API
  • API Form: Sodium salt
  • Appearance: White or yellowish powder
  • Solubility: Freely soluble in water, methanol and methylene chloride
  • Pharmacopoeial Reference: BP / Ph. Eur. monograph for Tianeptine Sodium

PubChem confirms the molecular formula, molecular weight and CAS number for Tianeptine Sodium.

Chemical and Pharmaceutical Profile

Tianeptine Sodium is chemically identified as sodium 7-[[(11RS)-3-chloro-6-methyl-6,11-dihydrodibenzo[c,f][1,2]thiazepin-11-yl]amino]heptanoate S,S-dioxide.

The sodium salt has a molecular weight of 458.9 g/mol. Its pharmaceutical properties differ from those of free Tianeptine, which has the formula C₂₁H₂₅ClN₂O₄S. Therefore, the free acid and sodium salt should not be combined into a single product specification.

Mechanism and Pharmacological Profile

Tianeptine has historically been described as a tricyclic antidepressant. Its pharmacological profile differs from that of conventional tricyclic antidepressants and selective serotonin reuptake inhibitors.

Tianeptine has been studied for effects involving serotonin neurotransmission and glutamatergic signaling. Its exact pharmacological profile depends on the biological and clinical context.

Pharmaceutical Applications

Tianeptine Sodium API is associated with pharmaceutical formulations developed for:

  • Antidepressant formulations
  • Pharmaceutical development and formulation research
  • Tricyclic antidepressant formulations
  • Authorized pharmaceutical applications involving Tianeptine Sodium
  • Analytical and pharmaceutical research

The regulatory status and permitted use of Tianeptine vary between countries, so commercial pharmaceutical use should follow the applicable local regulatory requirements.

QUALITY AND ANALYTICAL TESTING

Tianeptine Sodium API can be evaluated using appropriate pharmacopoeial and validated analytical procedures, including:

  • Infrared identification
  • Chromatographic identification
  • Assay
  • Impurity A determination
  • Related-substances testing
  • Water determination
  • Chromatographic system suitability
  • Residual-solvent testing where applicable
  • Elemental impurity assessment where applicable
  • Stability testing

The BP monograph uses liquid chromatography for related substances and provides specific system-suitability requirements for the analytical procedure.

PACKAGING AND STORAGE

Tianeptine Sodium is described as very hygroscopic, therefore appropriate moisture-protective packaging is important. The BP monograph specifies storage in an airtight container.

Recommended packaging considerations include:

  • Airtight primary container
  • Moisture-protective packaging
  • Suitable pharmaceutical-grade container
  • Proper batch identification
  • Appropriate secondary packaging

DOCUMENTATION

Depending on customer and regulatory requirements, documentation may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Safety Data Sheet (SDS)
  • Technical Data Sheet
  • Analytical test reports
  • Batch documentation
  • Stability information, where applicable
  • Packaging information
  • Regulatory documentation, where applicable

TIANEPTINE SODIUM API MANUFACTURER IN INDIA

Swapnroop Drugs & Pharmaceuticals focuses on quality-oriented pharmaceutical API manufacturing for authorized pharmaceutical customers.

As a Tianeptine Sodium API Manufacturer in India, Swapnroop focuses on:

  • Controlled API manufacturing processes
  • Product-specific analytical testing
  • Consistent batch quality
  • Pharmaceutical documentation
  • Quality-control procedures
  • Moisture-protective API packaging
  • Technical documentation support
  • Regulatory-oriented quality systems

WHY CHOOSE SWAPNROOP FOR TIANEPTINE SODIUM API?

  • Quality-focused pharmaceutical API manufacturing
  • Product-specific analytical controls
  • Consistent batch-to-batch quality
  • Pharmaceutical documentation support
  • India-based API manufacturing capabilities
  • Suitable moisture-protective packaging
  • Technical support for authorized pharmaceutical requirements

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 99.0% – 101.0%
Loss on Drying NMT 0.5%
Residue on Ignition NMT 0.1%
Water Content NMT 5.0%
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