CERTIFICATE OF ANALYSIS
PRODUCT NAME：KETOTIFEN FUMARATE
White to brownish-yellow,fine,crystalline powder
Sparingly soluble in water , slightly soluble in Methanol , very slightly soluble in acetonifrile
Clarity and colour of solution
Clear and not more than Y4BY4B4
Related substances(HPLC)
Impurity A
Impurity G
Single unknown impurity
Total impurities
Not more than 0.2%
Not more than 0.2%
Not more than 0. 15%
Not more than 0.5%
Acetone≤5000ppm
Methanol≤500ppm
Assay(potetiometic titration)
Calculated on the dried basis