Model NO.: Sorafenib Tosylate 475207-59-1
Trademark: MESOCHEM
Transport Package: 25kg
Specification: GMP
Origin: China
HS Code: 2934999090
Model NO.: Sorafenib Tosylate 475207-59-1
Trademark: MESOCHEM
Transport Package: 25kg
Specification: GMP
Origin: China
HS Code: 2934999090
Certificate  of  AnalysisProduct Name: Sorafenib tosylate
CASÂ No.:Â 475207-59-1
Â
Batch No. | HF161222 | Quantity | 12.5kgs |
Mfg. Date | Dec. 22, 2016 | Package | As required |
Rep. Date | Dec. 25, 2016 | Exp. Date | Dec. 21, 2018 |
Items | Standards | Results | |
Appearance | Off-white to white solid powder | Complies | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Solubility | Freely soluble in DMSO, slightly soluble in ethanol and water | Complies | |
Melting Point | 228ºC~230ºC | 228.8ºC~229.5ºC | |
Loss on Drying | ≤ 0.50% | 0.23% | |
Heavy Metal | ≤ 10ppm | Complies | |
Residue on Ignition | ≤ 0.10% | 0.06% | |
Related Substances | Any single impurity: ≤0.10% | 0.08% | |
Total Impurities: ≤1.00% | 0.22% | ||
Assay (HPLC basis on drying) |
98.0%~102.0% | 99.79% | |
Reference Standard | In-house Standard | ||
Conclusion | The product complied to In-house standard. | ||
Storage | Preserve in tight,light-resistant containers in a cool place |
Product Name: Sorafenib tosylate
CASÂ No.:Â 475207-59-1
Â
Batch No. | HF161222 | Quantity | 12.5kgs |
Mfg. Date | Dec. 22, 2016 | Package | As required |
Rep. Date | Dec. 25, 2016 | Exp. Date | Dec. 21, 2018 |
Items | Standards | Results | |
Appearance | Off-white to white solid powder | Complies | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Solubility | Freely soluble in DMSO, slightly soluble in ethanol and water | Complies | |
Melting Point | 228ºC~230ºC | 228.8ºC~229.5ºC | |
Loss on Drying | ≤ 0.50% | 0.23% | |
Heavy Metal | ≤ 10ppm | Complies | |
Residue on Ignition | ≤ 0.10% | 0.06% | |
Related Substances | Any single impurity: ≤0.10% | 0.08% | |
Total Impurities: ≤1.00% | 0.22% | ||
Assay (HPLC basis on drying) |
98.0%~102.0% | 99.79% | |
Reference Standard | In-house Standard | ||
Conclusion | The product complied to In-house standard. | ||
Storage | Preserve in tight,light-resistant containers in a cool place |