Terbinafine Hydrochloride EP Organic Chemical Alphabetical Listing Test Specification Min Max ASSAY

Test Specification Min Max ASSAY 98 103

Test Specification Min Max ASSAY (CHCl[@3@]

5 % COLOR (APHA) 10 ULTRAVIOLET ABSORBANCE (1 cm cell vs

07 AVAILABLE CHLORINE AT TIME OF PACKAGING 5% CALCIUM (Ca) 0

Terbinafine Hydrochloride EP Organic Chemical Alphabetical Listing Test Specification Min Max ASSAYTest Specification Min Max ASSAY (DRIED BASIS) 99 101. 00% RELATED SUBSTANCES: . . IMPURITY B 0. 15% IMPURITY E 0. 05% UNSPECIFIED IMPURITIES 0. 10 % each TOTAL IMPURITIES 0. 30% LOSS ON DRYING 0. 50% SULPHATED ASH 0. 10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION (A) SPECTRUM SPECTRUM IDENTIFICATION (B) POSITIVE POSITIVE EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS AS REPORTED