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SILDENAFIL CITRATE (CAS NO.171599-83-0), 1kg/bag
Item | SPECIFICATION |
Appearance | A white to off white Powder |
Solubility | Soluble in dimethylformamide, sparingly soluble in acetic acid and slightly soluble in methanol. |
Identification by A) IR B) Test for citrates | To complies as per I.P |
Melting Range | Between 182 C to 196 C |
Water by KFR | NMT 2.0% |
Citric acid content | 28.0 to 34.0% w/v |
Loss on drying at 105 C | NMT 1.0 % w/w |
Heavy metals | NMT 20 ppm |
Sulphated ash | NMT 0.10 % w/w |
Related substance by HPLC | N-Oxide impurity NMT 0.50 % Chloro sulphonyl impurity NMT 0.20 % Any other impurity NMT 0.30 % Total impurities NMT 1.5 % |
Assay by HPLC | Sildenafil citrate calculated on dried basis 98.0% to 102.0% w/w |
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