Solifenacin CAS NO.242478-38-2

tem

specifications

results

appearance

white or almost white crystalline powder

conforms

melting point

144.0-152.0°c

145.2-151.5°c

specific optical rotation

+34~+42°

+40.0°

loss on drying

≤ 1.0%

0.01%

residue on ignition

≤ 0.1%

0.04%

heavy metals

≤ 20ppm

conforms

ph

4.0-6.0

5.1

isomer

single isomer≤ 0.1%

total isomer≤ 0.3%

--

--

residual solvent

ethyl acetate≤ 0.5%

toluene≤ 0.089%

dmf≤ 0.088%

0.25%

0.03%

0.034%

related substance

single impurity≤0.1%

total impurity≤1.0%

0.08%

0.2%

assay(on dry basis)

≥98.5%

99. 3%