Sildenafil Citrate Drug
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Description
Specifications:
| Specifications: | |
| PRODUCT NAME : SILDENAFIL CITRATE | |
| TEST | STANDARDS |
| Chemical name | 1-[[3-(6,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4- ethoxyphenyl] sulphonyl]-4-methylpiperazine citrate |
| Description | White to off-White crystalline powder |
| Solubility | Soluble in DMF |
| Identification | A. IR Spectrum of sample shall be in Concordant with that of standard B. Test of chloride |
| Water Content | NMT 3.0 |
| Loss on Drying | Not more than 0.50% w/w |
| Sulphated Ash | Not more than 0.2% w/w |
| Melting Range | 188°C to 196°C |
| Heavy metals | Not more than 20 ppm |
| Citric Acid Content | Between 28% to 32% |
| Related Impurity (By HPLC) | Individual Impurity - NMT 0.5% Total Impurity - NMT 1.0% |
| Assay by HPLC | Between 98.0% - 102.0%(on dried basis) |
| Assay by Chemical | Between 98.0% - 102.0%(on dried basis) |
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Sildenafil Citrate Drug