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high purity Ketotifen fumarate cas:34580-14-8 Ketotifen fumarate Supplier
KETOTIFEN FUMARATE EP | ||||||
Batch NO.: | 1208036 | Manufacturing Date: | 2012.8.23 | |||
Quantity: | 40KGS | Certificate Date: | JAN 16,2013 | |||
Specification: | EP | Expiry Date : | 2015.8.23 | |||
ITEM | SPECIFICATION | RESULT | ||||
Appearance: | White to brownish-yellow,fine,crystalline powder | Complies | ||||
Solubility: | Sparingly soluble in water,slightly soluble in methanol,very slightly soluble in acetonifrile | Complies | ||||
Identification: | TLC | Complies | ||||
IR SPECTRUM | Complies | |||||
Clarity and colour of solution: | Clear and not more than Y4,BY4.B4 |
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Loss on drying: | Not more than 0.5% | 0.23% | ||||
Sulphated ash: | Not more than 0.1% | 0.02% | ||||
Related substances (HPLC) | ||||||
Impurity A: | Not more than 0.2% | 0.05% | ||||
Impurity G: | Not more than 0.2% | N.D. | ||||
Single unknown impurity: | Not more than 0.1% | N.D. | ||||
Total impurities: | Not more than 0.5% | 0.05% | ||||
Residual solvents: | Acelone ≤5000PPM | 1900PPM | ||||
Methanol ≤500PPM | <1PPM | |||||
Assay (potentiometic titration) calculated on the dried basis: | Between 98.5% and 101.0% | 99.50% | ||||
Conclusion: COMPLIES WITH EP |
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