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Ketotifen fumarate ;4,9-dihydro-4-(1-methylpiperidin-4-ylidene)-10H-benzo[4,5]cyclohepta[1,2-b]thiophene-10-one fumarat 4-(1-methyl-4-piperidylidene)-4h-benzo[4,5]cyclohepta[1,2-b]thiophen-10(9h)-one hydrogen fumarate
Solubility:Sparingly soluble in water,slightly soluble in methanol,very slightly soluble in acetonifrile
Identification: IR,TLC
Clarity and colour of solution: Clear and …
<p> Solubility:Sparingly soluble in water,slightly soluble in methanol,very slightly soluble in acetonifrile<br /> Identification: IR,TLC<br /> Clarity colour of solution: Clear not more than Y4BY4B4<br /> Loss on drying: ≤0.50%<br /> Sulphated ash: ≤0.1%<br /> Related substance (HPLC)<br /> Impurity A: ≤0.2%<br /> Impurity G: ≤0.2%<br /> Single unknown impurity: ≤0.1%<br /> Total impurities: ≤0.5%<br /> Residual solvents<br /> Acetone :≤5000ppm<br /> Methanol :≤5000ppm<br /> Assay(on dried basis): 98.5%~101.0%</p>
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