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Chemical name: (1R,3r,5S)-3-[(Hydroxydiphenylacetyl)oxy]spiro[8-azoniabicyclo[ 3.2.1]octane-8,1¢- pyrrolidinium] chloride.
Structural formula:
Molecular formula: C25H30ClNO3
Molecular weight: 428.0
Property: White or almost white, crystalline powder. Very soluble in water, freely soluble in methanol, practically insoluble in methylene chloride.
Specification: Standard EP6.0
Appearance:White or almost white, crystalline powder.
Appearance of solution:Solution S is clear and not more intensely coloured than reference solution B7..
pH :5.0 to 7.0.
Related Substances:
Impurity A: Not More Than 0.3%.
Impurity B: Not More Than 0.5%.
Impurity C: Not More Than 0.5%.
Any other Related compounds:Not More Than 0.1%.
Total Related Compounds:Not More Than 1.0%.
Loss on drying: Not more than 0.5%
Reidue on ignition: Not more than 0.1%
Assay:99.0% to 101.0% calculated on the anhydrous basis
Use:Treatment of Overactive bladder(OAB).
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