- Product Details
Keywords
- Alprostadil
- Prostaglandin E1
- PGE1
Quick Details
- ProName: Pharmaceutical Chemical Alprostadil 7...
- CasNo: 745-65-3
- Application: pharmaceutical ingredients
- DeliveryTime: Within 3-5 days
- PackAge: 1Kgs/Tin
- Port: shanghai
- ProductionCapacity: 500 Kilogram/Month
- Purity: 99% Min
- LimitNum: 0 Metric Ton
Superiority
GMP Manufacture, High quality, cheap price
Details
Alprostadil (PGE1)/Prostaglandin E1 CAS 745-65-3
Product Description
Product Name: Alprostadil
Appearance: White Powder
CAS: 745-65-3
MF: C20H34O5
MW:354.48
Sample: Avaiable
Category:Prostaglandin
Mini order: 10grams
Quality standard: USP/EP/JP
Alprostadil Injection, USP for intravascular infusion contains 500 micrograms Alprostadil, more commonly known as prostaglandin E1, in 1 mL dehydrated alcohol.
The chemical name for Alprostadil is (1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid, and the molecular weight is 354.49.
Alprostadil is a white to off-white crystalline powder with a melting point between 110° and 116° C. Its solubility at 35° C is 8000 micrograms per 100 mL double distilled water. The structural formula is represented below:
Application Pharmaceutical raw materials
Tests and Methods | Specifications | Results |
Appearance | White or slightly yellowish,crystalline powder. | Conforms |
Identification | ||
(1) HPLC | The retention time of the major peak in the chromatogram of Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay | Conforms |
(2) IR absorbance Spectrum | Both the test sample and the reference standard exhibit thesame intensity of absorption at the same wave number | Conforms |
Optical rotation | -60° to -70° (anhydrous substance). | -62.56° |
Water | N.M.T. 0.5% | 0.09% |
residue on ignition | N.M.T. 0.5% | 0.35% |
Purity | 99% | 99% |
|
Impurity A: N.M.T. 1.5% | Conforms |
Impurity B: N.M.T. 0.5% | Conforms | |
Any other impurity: N.M.T. 0.9% | Conforms | |
N.M.T one Impurity more than 0.5% | Conforms | |
Total Impurities: N.M.T. 1.5% | Conforms | |
2) Residual solvents
|
Ethyl acetate: N.M.T. 0.5% | Conforms |
N-heptane:N.M.T. 0.5% | Conforms | |
Acetone: N.M.T. 0.5% | Conforms | |
n-Hexane: N.M.T. 0.029% | Conforms | |
Assay | 95.0~102.5% ( anhydrous and solvent free basis) | 99.90% |
Conclusion | conforms to the requirements of EP7.0 |
What is Alprostadil
Alprostadil injection is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects.
Function
1.Alprostadil is used in maintaining a patent ductus arteriosus in newborns.
2. Alprostadil is also as urethral suppositories and in injectable form.
3.Alprostadil is also used for critical limb ischemia.