China Sorafenib Tosylate CAS No 475207-59-1, Find details about China Sorafenib Tosylate, 475207-59-1 from Sorafenib Tosylate CAS No 475207-59-1
Items | Standard | Results |
Appearance | White to yellow powder | White powder |
Solubility | Soluble in DMSO, slightly soluble in ethanol and almost insoluble in water | Complies |
Infrared absorption | The IR absorption spectrum of the sample shall be concordant with that of Sorafenib tosylate(Form 1) standard spectrum | Complies |
Para toluene sulfonic acid content potentiometry (On anhydrous basis) | In between 24.3%--29.7% | 25.6% |
Water | ≤1.0% | 0.06% |
HPLC | The retention time of the major peak in the chromatogram of the sample preparation shall correspond to that in the chromatogram of the standard preparation,as obtained in the assay by HPLC. | Complies |
Melting Point | 225-228ºC | 225-228ºC |
Identification | HPLC | Complies |
Residue on ignition | ≤0.5% | 0.08% |
Heavy metals | <20ppm | Complies |
Loss on Drying | < 1.0% | 0.09% |
Microbiological contamination | Total aerobic microbial count≤103cfu/g | ND |
Total combined Molds and Yeasts≤102cfu/g | ND | |
Escherichia Coli: Absent/g | ND | |
Related Impurity by HPLC | Total impurity ≤1.0% | 0.12% |
Single impurity≤0.5% | 0.09% | |
Amino carboxamide impurity≤0.09% | Complies | |
Dimer impurity≤0.09% | Complies | |
Highest individual unspecified impurity ≤0.09% | Complies | |
PSD | ≤100μm | Complies |
Assay(HPLC) | ≥99% | 99.88% |