| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
|
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| Ceritinib is a drug for the treatment of lung cancer. It is an ALK inhibitor. It was approved in April 2014 by the Food and Drug Administration for the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC) following treatment with crizotinib. 1.It is a tyrosine kinase inhibitor of anaplastic lymphoma kinase (ALK). It can promote the development of cancer cells by blocking the protein and inhibit the cells expressing EML4-ALK and NPM-ALK fusion protein. 2.Cerinib, a novel ALK inhibitor, is highly active in advanced patients. |
|
Analysis
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Specification
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Result
|
Test method
|
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Physical Description
|
|
|
|
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Appearance
|
White Powder
|
White Powder |
Visual
|
|
Odor
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Characteristic
|
Characteristic
|
Organoleptic
|
|
Particle size
|
90% pass 80 mesh
|
90% pass 80 mesh
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80 Mesh Screen
|
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Chemical Tests
|
|
|
|
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Assay (Lutein)
|
99%
|
90.15%
|
HPLC
|
|
Loss on drying
|
5.0% Max
|
1.82%
|
5g/105ºC/2hrs
|
|
Ash Contents
|
5.0% Max
|
1.12%
|
2g/525ºC/3hrs
|
|
Residual Solvents
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50.0 ppm, Only Ethanol
|
<30.0 ppm
|
/
|
|
Heavy metals
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5.0 ppm Max
|
<3.0 ppm
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AAS
|
|
Lead
|
3.0 ppm Max
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<1.0 ppm
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AAS
|
|
Arsenic
|
3.0 ppm Max
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<1.0 ppm
|
AAS
|
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Microbiology Control
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|
|
|
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Total Bacteria Count
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1,000cfu/g Max
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<280cfu/g
|
AOAC
|
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Yeast & Mold
|
100cfu/g Max
|
<10cfu/g
|
AOAC
|
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Coliform
|
30.0 MPN/g Max
|
<3.0 MPN/g
|
AOAC
|
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Conclusion
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Complies with the standards.
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General Status
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Non-GMO, ISO Certificated.
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