DESCRIPTION:
Trospium chloride is white or almost white, crystalline powder. Very soluble in water,
freely soluble in methanol, practically insoluble in methylene chloride.
CHEMICAL NAME:
(1R,3r,5S)-3-[(Hydroxydiphenylacetyl)oxy]spiro[8-azoniabicyclo[3.2.1]octane-8,1¢- pyrrolidinium] chloride.
MOLECULAR FORMULA: C25H30ClNO3
MOLECULAR WEIGHT: 428.0
SPECIFICATION:
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Properties
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Specification:Standard EP6.0
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Appearance
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white or almost white, crystalline powder.
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Appearance of solution
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Solution S is clear and not more intensely coloured than reference solution B7.
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Ph
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5-7
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Related substances
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≥90%
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Impurity A
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Not more than 0.3%
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Impurity B
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Not more than 0.5%
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Impurity C
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Not more than 0.5%
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Any other related compounds
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Not more than 0.1%
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Total related compounds
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Not more than 1.0%
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Loss on drying
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Not more than 0.5%
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Reidue on ignition
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Not more than 0.1%
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Assay
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99.0% to 101.0% calculated on the anhydrous basis.
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USE:Treatment of Overactive bladder(OAB).
