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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% | 99.2% |
1) Related Substances | 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 |
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.
1. Quality.Every batch of steroid powders have tobetested by our QC(quality control) before they are allowed to sell.
2. Delivery We have stock, so we can delivery quickly at the very day when receive the payment. Within 24 hours after receiving the payment Lead time 4 or 7 days.
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