Listing ID #7123965
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SR NO |
TEST |
SPECIFICATION |
RESULT |
1. |
Description |
White or almost white slightly hygroscopic crystalline powder. |
White Powder. |
2. |
Solubility |
Slightly soluble in water and in methanol Practically insoluble in hexane. |
Complies |
3. |
Identification |
||
By IR |
The IR absorption spectrum of sample should match to the spectrum of sildenafil citrate working standard. |
Complies |
|
4. |
Limit of Imidazole by TLC (%) |
Not more than 0.1 |
Complies |
5. |
Organic Impurity by HPLC (%) |
Impurity-A                              Not more than 0.3 Any other Unspecified Individual Impurity              Not more than 0.10 Total unspecified Impurities                               Not more than 0.3 Total Impurities                     Not more than 0.5 |
Not Detected  0.05  0.05 0.05 |
6. |
Water content by KF (% w/w) |
Not more than 2.5 |
1.60 |
7. |
Residue on Ignition |
Not more than 0.1 |
0.06 |