Cayman Pharma

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
Dinoprostone

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.

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