Dinoprostone
Product Name
| Alternative name |
Prostaglandin E2 (PGE2) |
| Brand name |
Cervidil™, Prostin E2™ |
| Chemical name |
9-oxo-11α,15S-dihydroxy-prosta-5Z,13E-dien-1-oic acid |
| CAS number |
363-24-6 |
Formula
| Formula |
C20H32O5 |
| Relative molecular weight |
352.46 |
| Structure |
|
Physiochemical data
| Solubility |
| Water |
slightly soluble |
| Ethanol 95% |
very soluble |
| Acetone |
very soluble |
| Chloroform |
very soluble |
| Diethyl ether |
soluble |
|
| UV absorbance |
- λmax = 206.9 nm
- Amax = 1.980 (3.0 mg in 10 ml ethanol)
|
| Appearance |
white or off-white crystalline powder |
| Melting point range |
melts with decomposition over the range of 64 - 65°C |
| pH value |
0.1% aqueous suspension has pH value about 3.65 |
| pK value |
4.6 |
Principal analytical parameters
| Assay (HPLC) |
97.0 - 102.0% abs. |
| Purity (HPLC, USP) |
|
| PGA2 |
max. 0.8% norm. |
| PGB2 |
max. 0.1% norm. |
| 5,6-trans PGE2 |
max. 1.5% norm. |
| Other impurities single |
max. 0.1% norm. |
| Other impurities total |
max. 1.0% norm. |
| Optical rotation |
[α]D20 = -82.0° to -90.0° (c=1, 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 of borosilicate glass DURAN) in a freezer at temperature below -18°C in a dry and dark place. Retest time is 24 months under these conditiions.
Use
Dinoprostone is used for cervical dilation during parturition. It can also be used as an adjunct for cervical ripening and to induce uterine contractions in other obstetrical situations.
