| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
|
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| Macitentan is a non-chiral sulphadiazine derivative. In vitro studies have shown that it is an oral active antagonist of endothelin ETA and ETB receptor, which can block endothelin-induced vasoconstriction in trachea and aorta. Developed by Swiss company Actelion Pharmaceuticals and first marketed in the United States with FDA approval on October 18, 2013, it is mainly used to treat pulmonary hypertension (PAH) and its product name is Opsumit. Compared with other drugs for pahs, masititan can significantly reduce the morbidity and mortality of pahs patients mainly by slowing the progression of disease. |
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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 | White powder | White powder |
Visual
|
|
Odor
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Characteristic
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Characteristic
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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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|
|
|
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Assay (Lutein)
|
99%
|
90.15%
|
HPLC
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|
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
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<30.0 ppm
|
/
|
|
Heavy metals
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5.0 ppm Max
|
<3.0 ppm
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AAS
|
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Lead
|
3.0 ppm Max
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<1.0 ppm
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AAS
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Arsenic
|
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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|
|
|
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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
|
100cfu/g Max
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<10cfu/g
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AOAC
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Coliform
|
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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