Treprostinil Sodium API Manufacturer and Supplier in India

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Treprostinil Sodium API Manufacturer and Supplier in India

Swapnroop Drugs & Pharmaceuticals is a pharmaceutical API manufacturer and supplier of Treprostinil Sodium, a synthetic prostacyclin analogue used in pharmaceutical applications for pulmonary arterial hypertension and related pulmonary vascular disorders.

Treprostinil Sodium is the sodium salt of treprostinil. It is identified by CAS No. 289480-64-4, molecular formula C23H33NaO5, and molecular weight 412.49 g/mol. FDA/GSRS and PubChem identify Treprostinil Sodium under UNII 7JZ75N2NT6.

Treprostinil Sodium API Overview

Treprostinil Sodium is a synthetic prostacyclin analogue that produces vasodilatory effects and inhibits platelet aggregation. It is used as an active pharmaceutical ingredient in formulations intended for the management of pulmonary arterial hypertension.

The drug substance is described as a white or pale yellowish powder. It is hygroscopic and is reported to be very soluble in water and ethanol, very slightly soluble in acetone, and practically insoluble in acetonitrile, n-hexane and ethyl acetate.

Chemical and Pharmaceutical Profile

  • Product Name: Treprostinil Sodium
  • CAS Number: 289480-64-4
  • UNII: 7JZ75N2NT6
  • Molecular Formula: C23H33NaO5
  • Molecular Weight: 412.49 g/mol
  • Parent API: Treprostinil
  • Parent CAS: 81846-19-7
  • Chemical Type: Sodium salt of a prostacyclin analogue
  • Pharmacological Class: Prostacyclin analogue
  • Therapeutic Category: Pulmonary Hypertension / Cardiovascular
  • API Type: Synthetic small-molecule API
  • Physical Form: Powder
  • Appearance: White to pale yellowish powder
  • Nature: Hygroscopic
  • Stereochemistry: Defined stereochemical configuration

PubChem independently confirms the molecular formula, molecular weight, CAS number and relationship to the parent treprostinil compound.

Pharmaceutical Applications

Treprostinil Sodium API is relevant to pharmaceutical applications involving:

  • Pulmonary arterial hypertension (PAH)
  • Pulmonary vascular disease
  • Prostacyclin analogue formulations
  • Cardiovascular pharmaceutical development
  • Inhalation pharmaceutical formulations
  • Oral and parenteral pharmaceutical development
  • Pharmaceutical research involving prostacyclin receptor agonists

Treprostinil Sodium is specifically identified as the drug-substance salt used in the development of treprostinil dry-powder inhalation products.

Treprostinil Sodium API Manufacturer and Supplier

Swapnroop Drugs & Pharmaceuticals supports pharmaceutical customers requiring Treprostinil Sodium API for formulation development and pharmaceutical manufacturing.

As a Treprostinil Sodium API manufacturer and supplier in India, Swapnroop focuses on controlled API quality, chemical identity, stereochemical integrity, assay, related substances, residual solvents and other applicable quality attributes according to the relevant product specification.

Packaging and Storage

Treprostinil Sodium is hygroscopic, so appropriate moisture-protective pharmaceutical packaging and controlled storage conditions are important for maintaining drug-substance quality.

The API should be handled and stored according to its validated manufacturer specification and stability data.

Documentation

Typical pharmaceutical documentation may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Batch Analytical Report
  • Safety Data Sheet (SDS)
  • Residual Solvent Data
  • Related-Substance / Impurity Profile
  • Stereochemical Characterization
  • Water / Moisture Data
  • Stability Documentation
  • Manufacturing Documentation
  • Regulatory Documentation, where applicable

Why Choose Swapnroop for Treprostinil Sodium API?

Swapnroop Drugs & Pharmaceuticals provides pharmaceutical customers with professionally managed Treprostinil Sodium API supply for pulmonary hypertension and cardiovascular pharmaceutical applications, with emphasis on consistent quality and appropriate analytical characterization.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 0.5%
Residue on Ignition NMT 0.1%
Water Content NMT 0.5%
Specific Rotation +38.0° to +44.0°
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