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TEST | SPECIFICATION | OBSERVATION |
---|---|---|
Description | A white or almost white, slightly hygroscopic , crystalline powder | White powder |
Solubility | Slightly soluble in water and in methanol, practically insoluble in hexane | Complies |
Identification (BV IR) | The IR absorption spectrum of the test sample should be similar to that of working standard | Complies |
Water by IG(%w/w) | NMT 2.5% | l.35Yo |
Reiated substance by FIPLC (o/ow/w) Sildenafil related compound A Unspecified impurities total unspecifi ed impurities Total irirpurities |
NMT 0.3% NMTO.I% NMT 0.3%
NMT 0.5% | Complies Complies Complies Complies |
Residue on ignition | NMTO.I% | 0.07% |
Heavy metal | NMT 20 ppm | Complies |
Limit of imidazole | NMT O.I% | Complies |
Assay by HPLC (Dry basis) (o/ow/w) | Not lesS than98.0o/o and not more than 102.0% | 99.85o/n |
Residual solvent Acetone Methylene chloride Ethyl acetate Toluene |
Not more thar 5000 ppm Not more than 600 ppm Not more than 5000 ppm Not more than 890 ppm |
Complies Complies Complies Complies |