| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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| Alectinib hydrochloride, developed by Chugai Pharmaceutical/ Hoffman-La Roche under the trade name Alecensa, was approved in Japan in April 2014 for the treatment of anaplastic lymphoma kinase (ALK) fusion-gene positive, unresectable, advanced, or recurrent non-small cell lung cancer (NSCLC). The compound is a highly selective second-generation ALK inhibitor, and while alectinib currently remains a focus of further development in Europe and the U.S., the compound has been granted orphan drug designation in Japan after showing a 93.5% objective response rate in phase II clinical trials. In addition to providing rapid treatment response time in a majority of patients, trials showed a 76% 2-year progression-free survival rate. Since the initial approval of crizotinib-the first ALK inhibitor indicated for treatment of ALKrearranged NSCLC -patients treated with crizotinib have shown remarkable improvement as compared to treatment with other chemotherapeutic methods,21 although drug resistance has shown to be a major side effect of this therapy. Preliminary preclinical and clinical studies of alectinib have shown significant promise for overcoming drug resistance developed with other ALK inhibitors. Alectinib hydrochloride is a highly selective and potent anaplastic lymphoma kinase (ALK) inhibitor capable of blocking the resistant gatekeeper mutant, which results in reduced cell growth. Also is an intermediate of Alectinib (C183360), a highly selective and potent anaplastic lymphoma kinase (ALK) inhibitor capable of blocking the resistant gatekeeper mutant, which results in reduced cell growth. |
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Analysis
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Specification
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Result
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Test method
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Physical Description
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Appearance
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White Powder
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White Powder |
Visual
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Odor
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Characteristic
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Characteristic
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Organoleptic
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Particle size
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90% pass 80 mesh
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90% pass 80 mesh
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80 Mesh Screen
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Chemical Tests
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Assay (Lutein)
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99%
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90.15%
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HPLC
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Loss on drying
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5.0% Max
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1.82%
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5g/105ºC/2hrs
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Ash Contents
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5.0% Max
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1.12%
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2g/525ºC/3hrs
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Residual Solvents
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50.0 ppm, Only Ethanol
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<30.0 ppm
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/
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Heavy metals
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5.0 ppm Max
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<3.0 ppm
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AAS
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Lead
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3.0 ppm Max
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<1.0 ppm
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AAS
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Arsenic
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3.0 ppm Max
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<1.0 ppm
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AAS
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Microbiology Control
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Total Bacteria Count
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1,000cfu/g Max
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<280cfu/g
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AOAC
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Yeast & Mold
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100cfu/g Max
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<10cfu/g
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AOAC
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Coliform
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30.0 MPN/g Max
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<3.0 MPN/g
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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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