Description

Treprostinil Sodium is a potent, stable prostacyclin analog used primarily as a vasodilator and platelet aggregation inhibitor. This high-purity active pharmaceutical ingredient (API) is critical for the formulation of life-saving medications targeting pulmonary arterial hypertension (PAH). It is essential for pharmaceutical manufacturers and research institutions developing innovative therapies for cardiovascular and pulmonary disorders. The compound is supplied under stringent quality controls to ensure batch-to-batch consistency and regulatory compliance.

Application

• Pharmaceutical API: Primary active ingredient in injectable and oral formulations for the treatment of pulmonary arterial hypertension (PAH).
• Drug Development: Key intermediate or reference standard in preclinical and clinical research for novel cardiovascular therapeutics.
• Generic Drug Manufacturing: Sourcing of the API for the production of generic versions of approved treprostinil-based medications.
• Formulation Research: Used in studies for developing new drug delivery systems, such as sustained-release formulations or inhalable powders.
• Analytical Standard: Serves as a high-purity standard for quality control testing, method validation, and regulatory submissions.

Basic Information

Item	Detail
Product Name	Treprostinil Sodium
CAS No.	289480-64-4
Molecular Formula	C23H33NaO6
Molecular Weight	428.50 g/mol
Synonyms	Treprostinil Sodium Salt; UNII-UDM7Q1Y8QO; (+)-(1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-Hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid monosodium salt; 15-Aminoprostaglandin I2 sodium salt; (15S)-15-Amino-9α,11α,13E,15S-prostadienoic acid sodium salt; Beraprost sodium (Note: Beraprost is a distinct analog, but often searched in relation); Remodulin® (brand name for formulated drug); Tyvaso® (brand name for formulated drug).
EINECS	Contact for details

Quality Control

Our Treprostinil Sodium is manufactured under cGMP (current Good Manufacturing Practice) conditions, ensuring the highest standards of purity and traceability. Each batch is subjected to a comprehensive battery of analytical tests, including identification, assay, impurity profiling, and residual solvent analysis, in full compliance with ICH Q3A, Q3B, and Q3C guidelines. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with agreed specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as specified on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with USP <61>

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.