Iloprost is a synthetic prostacyclin (PGI₂) analogue and active pharmaceutical ingredient used for its potent vasodilatory and antiplatelet properties. It acts primarily by stimulating prostacyclin receptors and increasing intracellular cyclic AMP in vascular smooth muscle and platelets.
Iloprost has the molecular formula C22H32O4 and a molecular weight of 360.49 g/mol. Its CAS Number is 78919-13-8.
Iloprost is a stable synthetic analogue of naturally occurring prostacyclin. It produces vasodilation and inhibits platelet aggregation and is used in pharmaceutical products for selected vascular disorders.
It is particularly associated with treatment of pulmonary arterial hypertension and severe peripheral arterial circulatory disorders, depending on the formulation and approved indication.
Iloprost binds to prostacyclin receptors on vascular smooth muscle cells and platelets. Receptor activation stimulates adenylate cyclase, increasing intracellular cyclic adenosine monophosphate (cAMP).
The resulting activity promotes vascular smooth-muscle relaxation and inhibits platelet aggregation.
Iloprost API is used in the development and manufacture of:
Iloprost is manufactured through controlled chemical synthesis followed by purification and isolation. Because prostacyclin analogues can be sensitive to environmental conditions, controlled processing, packaging and storage are important for maintaining API quality.
Quality control may include identification, assay, related substances, water content, residue on ignition, elemental impurities and residual solvents according to the applicable approved specification.
Iloprost is generally supplied as a white to off-white crystalline powder or solid. It is practically insoluble or sparingly soluble in water and may be soluble in suitable organic solvents.
Iloprost should be stored in a tightly closed container, protected from excessive heat, moisture and direct light. Storage conditions should follow the manufacturer's current CoA, SDS and validated stability requirements.
Depending on the intended pharmaceutical application, documentation may include:
Iloprost is a synthetic prostacyclin analogue with vasodilatory and antiplatelet activity. Its ability to relax vascular smooth muscle and inhibit platelet aggregation makes it an important pharmaceutical ingredient for selected pulmonary and peripheral vascular applications.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 4.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 2.0% |
| Melting Point | Approximately 95–105°C |