Products

Ketotifen Fumarate

Chemical FormulaC23H23NO5S

Chemical Weight425.4975

CAS number34580-14-8

Specification - Base on EP IV

AppearanceWhite to brownish-yellow,fine,crystalline powder

SolublilitySparingly soluble in water,slightly soluble in methanol,very slightly soluble in acetonifrile

IdentificationTLC / IR specturm (all complies)

Clarity of solutionClear

Color of solution≤Y4,BY4,B4 (result of < BY4)

Loss on Drying≤0.5% (result of 0.21%)

Sulphated Ash≤0.1% (result of 0.02%)

Related substancesImpurity ≤0.2% (result of None)

(HPLC)Impurity ≤0.2% (result of 0.07%)

Single unknown impurity ≤0.15% (result of none)

Total impurity ≤0.5% (result of 0.07%)

Residual solventsAcetone ≤5000PPM (result of 1850PPM)

Methanol ≤500PPM (result of <1PPM)

Assay98.0∼101.0% (result of 99.55%)

(Potentiometic titration)

(Dried basis)

Application

Package25kg/plastic bag in stick paper drum

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