Current API product portfolio
Sildenafil citrateSpecification:
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| chemical name: | 5-[2-ethoxy-5-(4-methylpiperazin-1-ylsulphonyl)-phenyl]-1-methyl-3-n-propyl- 1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-on citrat |
| molecular formula: | C28H38N6O11S |
| structural formula: |  |
| molecular weight: | 666.7 |
| CAS Registery number: | 171599-83-0 |
General information: Sildenafil citrate is white or almost white crystalline powder. The substance is slightly soluble in water and methanol, very slightly soluble in 96% ethanol, practically insoluble in chloroform. Soluble in hydrochloric acid (0.1 mole/l). |
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| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Melting point | 185°C - 195°C | Ph. Eur. |
| Colouration of 1% solution of sildenfil citrate | test solution is not more intensely coloured than B7 and BY7 standard acc. to Ph. Eur. | Ph. Eur. |
| Clarity of 1% solution of sildenafil citrate | test solution is not more opalescent than refernece suspension II acc. to Ph. Eur. | Ph. Eur. |
| Identification: - UV spectrum - IR spectrum - chemical identification (the raction of citrates) |
test substance UV spectrum corresponds to sildenafil citrate reference standard UV spectrum test substance IR spectrum corresponds to sildenafil citrate reference standard IR spectrum conformos |
POLPHARMA Ph. Eur. POLPHARMA |
| Chromatographic purity (HPLC): identified impurities: - impurity 1 - impurity 2 - impurity Z other single impurity sum of impurities |
not more than 0.10% not more than 0.10% not more than 0.10% not more than 0.10% not more than 0.50% |
POLPHARMA |
| Citrates (ion chromatography) | 25.8% - 31.6 % | POLPHARMA |
| Water content | not more than 2.0% | Ph. Eur. |
| Sulphated ash | not more than 0.2% | Ph. Eur. |
| Heavy me |
not more than 0.001% | Ph. Eur. |
| Assay of sildenafil citrate calculated on the anhydrous substance | 98.0% - 101.0% | POLPHARMA |
| Residual solvents: - methanol - ethanol - 2-propanol - dichloromethane - ethyl acetate - chloroform - toluene - N,N-dimethylacetamide |
not more than 300 ppm not more than 500 ppm not more than 3000 ppm not more than 60 ppm not more than 500 ppm not more than 30 ppm not more than 100 ppm not more than 300 ppm |
POLPHARMA |
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