Quetiapine Fumarate(CAS: 111974-72-2)
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Appearance
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A White or almost white crystalline powder
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Solubility
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Practically insoluble in water, soluble in glacial acetic acid, sparingly soluble in methanol and ethanol
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Melting range
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172-176℃
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Identification
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0.1g of sample make the purple of 0.01M potassium permanganate disappear and produce brown precipitation
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30μg/ml solution in water shows a max absorption at 289nm
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The IR spectrum is concordant with the reference standard
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Related substance (HPLC)
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Monoethylfumarate: 0.10% max
Piperazinyldibenzothiazepine: 0.10%max
Dibenzothiazepinone: 0.10% max
Hydroxyethylpiperazinyldibenzothiazepine : 0.10% max
Ethylpiperazinyidibenzothiazepine: 0.10% max
Morpholinodibenzothiazepine: 0.10% max
Chlorodibenzothiazepine: 0.10% max
Any other individual impurity : 0.10% max
Total impurities : 0.5% max
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PH
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5.0-6.0
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Loss on drying
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0.5% max
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Residue on ignition
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0.1% max
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Heavy metals
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0.001% max
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Assay (on anhydrous basis)
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98.5-101.0%
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