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Assay: 99% min.
Character: White to Off-White Cyrstalline Solid.
Usage: Used for the treatment of erectile dysfunction. A phosphodiesterase 5 inhibitor.
Categories: Active Pharmaceutical Ingredients; Cnbio; Erectile Dysfunction; Inhibitors; Intermediates & Fine Chemicals; Pharmaceuticals; API's.
Avanafil occurs as white crystalline powder, molecular formula C23H26ClN7O3 and molecular weight of 483.95 and is slightly soluble in ethanol, practically insoluble in water, and soluble in 0.1 mol/L hydrochloric acid. STENDRA, for oral administration, is supplied as oval, pale yellow tablets containing 50 mg, 100 mg, or 200 mg avanafil debossed with dosage strengths. In addition to the active ingredient, avanafil, each tablet contains the following inactive ingredients: mannitol, fumaric acid, hydroxypropylcellulose, low substituted hydroxypropylcellulose, calcium carbonate, magnesium stearate, and ferric oxide yellow.
Avanafil comes as a tablet to take by mouth. It is usually taken with or without food as needed, about 30 minutes before sexual activity. Do not take avanafil more often than once in 24 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take avanafil exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor will probably start you on an average dose of avanafil and may increase or decrease your dose depending on how you respond to the medication. Tell your doctor if avanafil is not working well or if you experience side effects.
|Appearance||White powder||White powder|
|Total impurities||Not more than 0.5%||0.15%|
|Individual Impurity||Not more than 0.1%||0.06%|
|Loss on drying||≤0.5%||0.3%|
|Conclusion:||Comply with enterprise standard|