Sildenafil

TESTS

STANDARD

RESULTS

Appearance

White or almost white, slightlyhygroscopic crystalline powder.

Almost white, slightly hygroscopic crystalline powder.

Solubility

Slightly soluble in water and inmethanol, practically insoluble in hexane.

Complies

Identification

By Infrared absorptionspectrophotometry

Complies

Impurity E [By TLC]

NMT0.1%

Complies

RelatedSubstances[ByHPLC]

Impurity A                                   : NMT 0.3%

UnspecifiedImpurity                  : NMT 0.1% Sum of unspecified Impurities : NMT 0.3% Total Impurities                  : NMT 0.5%

Nil 0.07%

0.12%

0.22%

HeavyMetals

Maximum 20ppm

Less than 20ppm

Water

Maximum2.5%

1.80%

SulphatedAsh

Maximum0.1%

0.07%

Assay [ByH.P.L.C.]

Between 98.0% to102.0% [of anhydrous substance]

99.45%