1. Standard:BP/EP 2. Packing:1kg/Tin; 5 Tins per Carton 3. Lead time:15-20 days after receiving the original L/C or paymen

Product Name	Ketotifen Fumarate
Quanlity Standard:	BP2007
ITEM	SPECIFICATION
Characters:	White to brownish-yellow,fine,crystalline powder.
Identification:	TLC
	IR spectrum
Solubility:	Sparingly soluble in water,slightly soluble in methanol,very slightly soluble in acetonifrile
Clarity and colour of solution:	Clear and not more than Y4,BY4,B4
Loss on drying:	Not more than 0.5%
Sulphated ash:	Not more than 0.1%
Related substances(HPLC)
Impurity A:	Not more than 0.2%
Impurity G:	Not more than 0.2%
Single unknown impurity:	Not more than 0.10%
Total impurities:	Not more than 0.5%
Residual solvents:	Acetone ≤5000PPM                                                    Methanol ≤500PPM
Assay (potentiometic titration) Calculated on the dried basis	Between 98.5% and 101.0%

KETOTIFEN FUMARATE BP2007