Treprostinil Diethanolamine API Manufacturer and Supplier in India

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Treprostinil Diethanolamine API Manufacturer and Supplier in India

Swapnroop Drugs & Pharmaceuticals is a pharmaceutical API manufacturer and supplier of Treprostinil Diethanolamine, also known as Treprostinil Diolamine or UT-15C. Treprostinil Diethanolamine is a synthetic small-molecule salt of treprostinil and a prostacyclin analogue used in pharmaceutical development and formulations for pulmonary hypertension.

Treprostinil Diethanolamine is identified by CAS No. 830354-48-8, molecular formula C27H45NO7, and molecular weight approximately 495.66 g/mol. FDA substance records identify Treprostinil Diolamine with UNII H1FKG90039.

Treprostinil Diethanolamine API Overview

Treprostinil Diethanolamine is the 1:1 diethanolamine salt of treprostinil. It contains the active prostacyclin analogue treprostinil together with diethanolamine and has a defined stereochemical configuration. FDA chemistry documentation describes the material as a white to cream-colored solid with five chiral centers and a defined single stereoisomer at each center.

The API is associated with prostacyclin-mediated vasodilation and inhibition of platelet aggregation and is used in pharmaceutical products and development programs involving pulmonary arterial hypertension (PAH) and related pulmonary hypertension conditions.

Chemical and Pharmaceutical Profile

  • Product Name: Treprostinil Diethanolamine
  • Synonyms: Treprostinil Diolamine, Treprostinil Diethanolamine Salt, UT-15C
  • CAS Number: 830354-48-8
  • UNII: H1FKG90039
  • Molecular Formula: C27H45NO7
  • Molecular Weight: 495.66 g/mol
  • Chemical Type: Diethanolamine salt
  • Pharmacological Class: Prostacyclin analogue
  • Therapeutic Category: Pulmonary Hypertension / Cardiovascular
  • API Type: Synthetic small-molecule API
  • Physical Form: Crystalline solid
  • Appearance: White to cream-colored solid
  • Stereochemistry: Defined stereochemical configuration

PubChem and FDA substance records support the identity, formula, molecular weight and CAS number.

Pharmaceutical Applications

Treprostinil Diethanolamine is associated with pharmaceutical applications involving:

  • Pulmonary arterial hypertension
  • Pulmonary hypertension
  • Prostacyclin analogue formulations
  • Cardiovascular pharmaceutical development
  • Prolonged-release oral formulations
  • Pharmaceutical research involving prostacyclin receptor agonists

EMA records specifically identify Treprostinil Diethanolamine as an active substance investigated for pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.

Treprostinil Diethanolamine API Manufacturer and Supplier

Swapnroop Drugs & Pharmaceuticals supports pharmaceutical companies requiring Treprostinil Diethanolamine API for formulation development, pharmaceutical manufacturing and regulated supply requirements.

As a Treprostinil Diethanolamine API manufacturer and supplier in India, Swapnroop focuses on identity, assay, stereochemical characteristics, residual solvents, moisture and other relevant quality attributes according to the applicable product specification.

Packaging and Storage

Treprostinil Diethanolamine should be stored in suitable pharmaceutical packaging under controlled conditions that protect the material from moisture, contamination and inappropriate temperature exposure.

Published process data describe Treprostinil Diethanolamine as a crystalline solid and report controlled drying under vacuum.

Documentation

Typical documentation can include:

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

Why Choose Swapnroop for Treprostinil Diethanolamine API?

Swapnroop Drugs & Pharmaceuticals provides pharmaceutical customers with professionally controlled Treprostinil Diethanolamine API supply, supporting quality requirements for cardiovascular and pulmonary hypertension pharmaceutical applications.

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 0.5%
Water Content NMT 0.5%
Melting Point 104.5–106.5°C*
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