Appearance: white or light yellow powder.
Solubility: very soluble or freely soluble in water, soluble in
ethanol (96 per cent), practically insoluble in heptane.
IDENTIFICATION
A. Infrared absorption spectrophotometry (2.2.24).
Comparison: solifenacin succinate CRS.
B. Isomeric purity (see Tests).
TESTS
Isomeric purity. Liquid chromatography (2.2.29).
Test solution. Dissolve 50 mg of the substance to be examined
in the mobile phase and dilute to 20.0 mL with the mobile
phase.
Reference solution (a). Dissolve the contents of a vial of
solifenacin for system suitability CRS (containing impurities F,
G and H) in 1.0 mL of the mobile phase.
Reference solution (b). Dilute 1.0 mL of the test solution to
100.0 mL with the mobile phase. Dilute 1.0 mL of this solution
to 10.0 mL with the mobile phase.
Loss on drying (2.2.32): maximum 0.5 per cent, determined
on 1.000 g by drying in an oven at 105 °C for 3 h.
Sulfated ash (2.4.14): maximum 0.1 per cent, determined on
1.0 g.
ASSAY
Dissolve 0.400 g in 50 mL of anhydrous acetic acid R. Titrate
with 0.1 M perchloric acid, determining the end-point
potentiometrically (2.2.20
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