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Prostaglandin E1 745-65-3 Prostaglandin E1 745-65-3
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Leah| Senior Sales | Qingdao Sigmachemical Co.,Ltd
| Wechat/Whatsapp/Skype/Phone Number. +86 186 63970593
| Email:sales@sigmachemical.com.cn
| Address:No 70,Shandong Road,Qingdao city,China
Product Description
The main component of this product is prostaglandin E1, its chemical name is (1R, 2R, 3R) -3-hydroxy-2 (E) - (3S) -3-hydroxy-1-octenyl- Alkanoic acid.
Alprostadil injection for the treatment of chronic arterial occlusion caused by limb ulcers and microvascular circulatory disorders caused by resting pain in the limbs, improve cardiovascular and cerebrovascular microcirculation disorders. Antithrombotic therapy after organ transplantation to inhibit thrombosis in transplanted blood vessels. Pediatric congenital heart disease patent ductus arteriosus, to alleviate hypoxemia, keep the catheter to wait for the timing of surgical treatment
Certification of Analysis
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 |
Identical |
(2) IR absorbance Spectrum |
Both the test sample and the reference standard exhibit the same intensity of absorption at the same wave number (wavelengths). (potassium bromide disk method) |
Identical |
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% | Not detected |
Impurity B: N.M.T. 0.5% | Not detected | |
Any other impurity: N.M.T. 0.9% | Not detected | |
N.M.T one Impurity more than 0.5% | Conforms | |
Total Impurities: N.M.T. 1.5% | Not detected | |
2) Residual solvents | Ethyl acetate: N.M.T. 0.5% | 0.22% |
N-heptane:N.M.T. 0.5% | 0.01% | |
Acetone: N.M.T. 0.5% | Not detected | |
n-Hexane: N.M.T. 0.029% | Not detected | |
Assay | 95.0~102.5% ( anhydrous and solvent free basis) | 99.90% |
Conclusion: conforms to the requirements of EP7.0 |
Function&Application
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.
In infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment pO2 values; that is, patients with low pO2 values respond best, and patients with pO2 values of 40 torr or more usually have little response.
Alprostadil injection should be administered only by trained personnel in facilities that provide pediatric intensive care.
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