KETOTIFEN FUMARATE BP2007
Wincom Company Ltd. [China]
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