| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the formation of leukotrienes from arachidonic acid. Zileuton has the chemical name (±)-1(1-Benzo[b]thien-2-ylethyl)-1-hydroxyurea and the following chemical structure: Zileuton has the molecular formula C11H12N2O2S and a molecular weight of 236.29. It is a racemic mixture (50:50) of R(+) and S(-) enantiomers. Zileuton is a practically odorless, white, crystalline powder that is soluble in methanoand ethan, slightly soluble in acetonitri, and practically insoluble in water. The melting point ranges from 144.2°C to 145.2°C. ZYFLO tablets for oral administration are supplied in one dosage strength containing 600 mg of zileuton. |
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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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