Description

White or almost white powder

almost white powder

Solubility

Very slightly or slightly soluble in water, freely soluble

in anhydrous ethanol and in methano.l,

slightly soluble in aceton.e

Complies

Identification

Infrared absorption spectrophotometry.

Comparison: terbinafine hydrochloride CRS

Complies

It gives reaction (a) of chlorides using anhydrous

ethanol R as solvent

Related

Substances

Impurity B: not more than 0.15%,

Complies

Impurity E: not more than 0.05%, impurity

Complies

unspecified impurities:each Impuritynot more than 0.1%

Complies

Sum of impurity : not more than 0.3%

Complies

Loss on drying

≤0.5%

0.40%

Sulfated ash

≤0.1%

0.01%

Residual Solvent

ethyl aceta.te≤0.5%

ethyl acetat.e≤0.5%

Assay

99.0%-101.0%

100.29%