Ketotifen Hydrogen Fumarate EP Diphenylmethanes 5 ueq/g TITRABLE BASE 3

5 ueq/g TITRABLE BASE 3 ueq/g WATER 0

Test Specification Min Max ASSAY (Bi[@2@]O[@3@]

Test Specification Min Max ASSAY (C[@10@]H[@12@]CaN[@2@]Na[@2@]O[@8@]) 97 102

10% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS: TO PASS TEST

SPECIFIC ROTATION OPTICALLY INACTI OPTICALLY INACTI APPEARANCE OF SOLUTION TO PASS TEST NONVOLATILE RESIDUE 0

Ketotifen Hydrogen Fumarate EP Diphenylmethanes 5 ueq/g TITRABLE BASE 3Test Specification Min Max ASSAY (DRIED BASIS) 98. 5 101. 00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST RELATED SUBSTANCES TO PASS TEST TO PASS TEST LOSS ON DRYING 0. 50% SULPHATED ASH 0. 10% ELEMENTAL IMPURITIES: PALLADIUM (Pd) AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST CLASS 2 (solvent) CYCLOHEXANE 3880 ppm CLASS 2 (SOLVENT)