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Alprostadil
Product Name
| Alternative name |
Prostaglandin E1 (PGE1) |
| Brand name |
Caverject™, Edex™, Muse™, Prostin VR™ |
| Chemical name |
(11α,13E,15S)-11,15-dihydroxy-9-oxoprosta-13-en-1-oic acid |
| CAS number |
745-65-3 |
Formula
| Formula |
C20H34O5 |
| Relative molecular weight |
354.50 |
| Structure |
|
Physiochemical data
| Solubility |
| Water |
slightly soluble |
| Ethanol 95% |
very soluble |
| Acetone |
very soluble |
| Chloroform |
very soluble |
| Diethyl ether |
soluble |
| Hexane |
practically insoluble |
|
| UV absorbance |
- λmax = 202.3 nm
- Amax = 0.858
|
| Appearance |
white or off-white crystalline powder |
| Melting point range |
114 - 116°C |
| pH value |
0.1% suspension in water has pH value about 3.65. |
| Crystallinity |
All studies made proved the existence of only a single crystalline form. |
Principal analytical parameters
| Assay (HPLC) |
96.0 - 102.5% abs. |
| Purity (HPLC, USP) |
|
| PGA1 |
max. 1.3% abs. |
| PGB1 |
max. 0.1% abs. |
| Total impurities |
max. 2.0% mol. |
| Optical rotation |
[α]D20 = -60.0° to -70.0° (c=0.5, ethanol) |
| Water |
max. 0.5% abs. |
Product quality complies with USP XXVI and EP 2002 for category 2 and 3A of non-sterile products. Complete specification is available upon request.
Storage and stability
The product is stored in immediate packaging (bottle Dynalon - Vectra of HDPE) in a refrigerator at temperature 2 - 8°C in a dry and dark place. Retest time is 36 months under these conditions.
Use
Alprostadil is a vasodilator, and finds clinical use in treating erectile dysfunction, in improving blood flow in peripheral vascular disease, and in maintaining coronary circulation in neonates with vascular anomalies.
