| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
|
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Regorafenib is a small molecule inhibitor of a variety of membrane-bound and intracellular kinases that are involved in normal cell function and pathological processes such as tumorigenesis, tumor angiogenesis, tumor metastasis, and tumor immunity. In vitro tests, Regorafenib and its main active metabolites M-2 and M-5 can inhibit RET, VEGFR1, VEGFR2, VEGFR3, KIT, PDGFR-α, PDGFR-β, FGFR1, FGFR2, TIE2, DDR2, TrkA, Eph2A, RAF-1, B at clinical concentrations RAF, BRAFV600E, SAPK2, PTK5, Ab1 and CSF1R kinase activity.
This product is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) who have previously received fluorouracil, oxaliplatin and irinotecan based chemotherapy, and who have previously received or are not suitable for anti-VEGF or anti-EGFR therapy (RAS wild type). Patients with locally advanced, inoperable, or metastatic gastrointestinal stromal tumors (GIST) previously treated with imatinib mesylate and Sunitinib malate, and patients with hepatocellular carcinoma (HCC) previously treated with sorafenib.
| Item | Test Standard | Testing Result | |
| Assay | 99% | Complies | |
| Apperence | White Powder | Complies | |
| Particle Size | 100% pass 80 mesh | Complies | |
| Oder | Characteristic | Complies | |
| Taste | Characteristic | Complies | |
| Loss on Drying | ≤5.0% | 2.20% | |
| Residue on Ignition | ≤0.1% | 0.05% | |
| Residual | ≤0.1% | Complies | |
| Residual Ethanol | ≤0.5% | Complies | |
| Heave Mentals | ≤10ppm | Complies | |
| Na | ≤0.1% | <0.1% | |
| Pb | ≤3 ppm | Complies | |
| Total Plate | <1000CFU/g | Complies | |
| Yeast & Mold | <100 CFU /g | Complies | |
| E. Coli | Negative | Complies | |
| Salmonella | Negative | Complies | |
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