China Solifenacin Succinate Good Quality Competitive Price, Find details about China Solifenacin, Solifenacin Succinate from Solifenacin Succinate Good Quality Competitive Price
Test Items | Specification | Test Results |
Appearance | White or off-white solid | White solid |
Identification | A:Infrared absorption B: The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. C: The retention time of the succinic acid of sample solution corresponds to that of the standard solution as obtained in succinic acid assay. | Conforms Conforms Conforms |
Loss on drying | ≤0.5% | 0.08% |
Residue on ignition, % | ≤0.1% | 0.02% |
Heavy metals | ≤10ppm | Conforms |
Related substances | S0002≤0.1% S0003≤0.1% S0006≤0.1% S0030≤0.1% S0033≤0.1% S0025≤0.1% S0031≤0.1% Other individual impurity≤0.1% Total impurities≤0.3% | <0.0011% <0.0031% 0.020% <0.0015% <0.0004% <0.0043% <0.0031% N/D 0.030% |
Isomeric impurity | S0022≤0.1% S0023≤0.1% S0024≤0.1% | <0.001% <0.001% <0.002% |
Residue of solvents | Methanol≤3000ppm Ethanol≤5000ppm DCM≤600ppm Ethyl acetate≤5000ppm Totuene≤890ppm Benzene≤2ppm Acetic acid≤5000ppm N,N-dimethylformamide≤880ppm | ND 100ppm ND 100ppm 5ppm ND ND ND |
Assay | C23H26N2O2·C4H6O4(anhydrous basis)98.0%~102.0% | 100.0% |
Assay of succinic acid | 23.4%~25.8% | 24.5% |
Impurity of S0008 | ≤0.1% | Conforms |
Microbial limit | Total aerobic bacteria: ≤1000cfu/g Total mould and yeast: ≤100cfu/g E-coli: ND | <10cfu/g <10cfu/g ND/g |