Sildenafil is used to treat men who have erectile dysfunction (also called sexual impotence). Sildenafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works.

Specification:

• Tests Specifications Result
• Description: White or almost white crystalline powder ( Results: White crystalline powder)
• Solubility : diffluent in Ach, slightly soluble in methanol,almost insoluble in chloroform (Results: Complies)
• Identification
• HPLC : Comply with standard (Results: Complies)
• A292/A227 : 2.28~2.42 (Results: 2.36)
• IR: IR should comply with the reference standard spectrum. (Results: Complies)
• citrate :positive (Results: Complies)
• Acidity :3.0~5.0 (Results: 3.63)
• Loss on Drying: ≤1.0% (Results: 0.32%)
• Residue on ignition :≤0.1% (Results: 0.04%)
• Heavy Metals : ≤20ppm (Results: Complies)
• Relevant Impurity : ≤0.5% (Results: 0.28%)
• Methanol : ≤0.3% (Results: 0.02%)
• Methylene dichloride : ≤0.06% (Results: 0.017%)
• N,N-Dimethyl formamide : ≤0.088% (Results: Not detected)
• Assay : 98.5~101.5% (Results: 99.6%)