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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 |
White crystalline powder |
|
Solubility |
diffluent in Ach, slightly soluble in methanol,almost insoluble in chloroform |
Complies |
|
Identification |
||
|
HPLC |
Comply with standard |
Complies |
|
A292/A227 |
2.28~2.42 |
2.36 |
|
IR |
IR should comply with the reference standard spectrum. |
Complies |
|
citrate |
positive |
Complies |
|
Acidity |
3.0~5.0 |
3.63 |
|
Loss on Drying |
≤1.0% |
0.32% |
|
Residue on ignition |
≤0.1% |
0.04% |
|
Heavy Metals |
≤20ppm |
Complies |
|
Relevant Impurity |
≤0.5% |
0.28% |
|
Methanol |
≤0.3% |
0.02% |
|
Methylene dichloride |
≤0.06% |
0.017% |
|
N,N-Dimethyl formamide |
≤0.088% |
Not detected |
|
Assay |
98.5~101.5% |
99.6% |
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
