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Pharmaceutical Chemical Alprostadil 745-65-3 Prostaglandin E1 99% USP Standard Cheap Price Quality Guarantee

Pharmaceutical Chemical Alprostadil 745-65-3 Prostaglandin E1 99% USP Standard Cheap Price Quality Guarantee

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Alprostadil Prostaglandin E1 PGE1

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  • Application:pharmaceutical ingredients
  • PackAge:1Kgs/Tin
  • ProductionCapacity:500|Kilogram|Month
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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

COA of alprostadil powder
 
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%
 
 
 
 
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

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.

 

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