Basic information of Alprostadil API
- Alprostadil API
- CAS No.：745-65-3
- Synonym Prostaglandin E1 Powder; PGE1
- Formula：C20H34O5
- Molecular Weight：354.48
- Chemical purity：≥99.0%
- Appearance White to off-white crystalline powder
What is Alprostadil?
Alprostadil is a synthetic prostaglandin E1 compound. High-purity API is a white or off-white crystalline powder. It works by mimicking the biological activity of natural prostaglandins in the human body, primarily acting as a vasodilator. Finished dosage forms are primarily used to treat cardiovascular disease and erectile dysfunction.
Highassay is a professional Alprostadil raw materials manufacturer and supplier in China.
If you have any questions about misoprostol’s technical specifications, Highassay’s R&D team is ready to assist you.
What are the main finished dosage forms of Alprostadil?
Currently, there are two mainstream formulations on the market: Alprostadil Injection and Alprostadil Cream.
Common Alprostadil Injection strengths include 1ml: 5μg, 2ml: 10μg, and USP 500 mcg/ml in vial form.
Common brands include: Caverject®, Caverject Impulse®, Edex®, and Muse®.
Alprostadil cream strengths include 200mcg and 300mcg.
Common brands include Vitaros 3mg/g crema, 4 Aplicadores de un solo uso (aplicador por bolsa) produced by CASEN RECORDATI, S.L., Spain.
Applications of Alprostadil
Treatment of extremity ulcers caused by chronic arterial occlusive disease (thromboangiitis obliterans, arteriosclerosis obliterans, etc.), as well as resting pain in the extremities caused by microvascular circulatory disorders, and improvement of cardiovascular and cerebrovascular microcirculatory disorders.
Antithrombotic therapy after organ transplantation, used to inhibit thrombosis within the transplanted vessels.
In patients with ductus arteriosus-dependent congenital heart disease, to alleviate hypoxemia and maintain ductal blood flow while awaiting surgical treatment.
It dilates the penile arteries, relaxes the corpus cavernosum smooth muscle, and accelerates penile arterial blood flow. Suitable for the diagnosis and treatment of erectile dysfunction.
Advantages of Highassay Alprostadil API Powder
Highassay adheres to strict quality control (QC) at every stage of production to produce the Alprostadil active pharmaceutical ingredient. We offer two grades of API: reagent grade and GMP grade.
Reagent grade is for general laboratory and pilot use.
GMP grade is available with DMF and other relevant registration documents. If you require a more detailed reference COA, please contact us.
Highassay offers both lab-grade and GMP-grade grades. Purities range from 97%, 98%, and 99%. Lab-grade grades fully support domestic and international drug development. GMP-grade grades support commercial production and can provide relevant registration documents.
Highassay offers both lab-grade and GMP-grade grades. Purities range from 97%, 98%, and 99%. Lab-grade grades fully support domestic and international drug development. GMP-grade grades support commercial production and can provide relevant registration documents.
Delivery is typically one week.
Express shipping is typically used, such as FedEx.
Highassay commercially produces Alprostadil on a regular basis and maintains inventory year-round.
Price discounts are available for bulk purchases. Please contact us for specific discounts.
Specification of Alprostadil（E1）
| Product name | Alprostadil（E1） | CAS No. | 745-65-3 |
| Storage Condition: | Alprostadil should be kept in a well-sealed container, protected from humidity and stored in a refrigerator (2-8℃) immediately after received. | ||
| Items | Specification | Results |
| Appearance | White to off-white crystalline powder | white crystalline powder |
| Identification | IR Spectrum | Complies |
| Water | Not more than 0.5% | 0.28% |
| Residue on Ignition | Not more than 0.5% | 0.05% |
| Limit of prostaglandin A1, prostaglandin B1, and 13,14-dihydroprostaglandin E1 | 1) Prostaglandin A1 should not be more than 1.5% 2) prostaglandin B1 not more than 0.1% 3) Sum of prostaglandin B1 and 13,14-dihydroprostaglandin E1 should not be more than 0.5% | 0.12%
N.D.
0.21%
|
| Limit of foreign prostaglandins | 1) Single foreign prostaglandin not more than 0.9% 2)Total foreign prostaglandins not more than 2.0% | N.D.
N.D.
|
| Limit of chromium | Not more than 20 ppm | Complies |
| Limit of rhodium | Not more than 20 ppm | Complies |
| Assay | 95.0%~105.0% | 97.2% |
| Residual solvents | Ethyl acetate should be not more than 4000 ppm Hexane should be not more than 200 ppm | 2334ppm
N.D. |
| Conclusion: | Complies with USP standards. | |
