Customization: | Available |
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Powder: | Yes |
Customized: | Customized |
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Item | Test Standard | Testing Result | |
Purity | 98% | ||
THC | Not detected | Undetected | |
Assay | Method HPLC calculated on the anhydrous basis limit of quotation (LOQ) 0.8ppm | ||
Appearance | White powder | White powder | |
Identification | In the recorded chromatograms under the determination of the substance, retention time of the main peak of the solution should be consistent with the retention of time of the main peak of the reference solution | Complies | |
Melting Point | 65~66ºC | 65.5ºC | |
Loss on Drying | NMT 1.0% | 0.21% | |
Residual solvents | Ethanol NMT 400ppm Heptane NMT 400ppm |
1.92ppm 256.0ppm |
|
Heavy Mental | NMT 20ppm | Complies | |
Microbial Limite Test | Method: Plate Counting | ||
Total aerobic bacteria count | NMT 1000cfu/g | Complies | |
Combined molds and yeast | NMT 100cfu/g | Complies | |
E. Coli | Not detacted per gram | Complies | |
Salmanella | Not detacted per 10 gram | Complies | |
Conclusion: Conform the testing result is qualified |
Function & Application
Brigatinib, also known as AP-26113, is an orally active, potent and selective Dual ALK/EGFR inhibitor. AP26113 binds to and inhibits ALK kinase and ALK fusion proteins as well as EGFR and mutant forms. This leads to the inhibition of ALK kinase and EGFR kinase, disrupts their signaling pathways and eventually inhibits tumor cell growth in susceptible tumor cells. In addition, AP26113 appears to overcome mutation-based resistance. ALK belongs to the in sulin receptor superfamily and plays an important role in nervous system development; ALK dysregulation and gene rearrangements are associated with a series of tumors. EGFR is overexpressed in a variety of cancer cell types.