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Quanzhou Fortune Biopharma Co.,Ltd.
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Product name: oseltamivir phosphate
Chemical name: (3 r, 4 r, 5 s) - 4 - ethyl amide group - amino - 3-5 - (1 -) ethyl propyl oxygen radicals - 1 - cyclohexene - 1 - carboxylic acid ethyl ester phosphate Oseltamivir phosphate;
Baton rouge (3 r, 4 r, 5 s) - 4 - acetamido - 5 - amino - 3 - pentan - 3-1 - carboxylate yloxycyclohexene - phosphate
MF: C16H28N2O4.H3PO4
NW: 410.40
Appearance: white to yellowish-white powder
CAS No: 204255-11-8
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Sinoway Industrial Co.Ltd.
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Product name
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Oseltamivir Phosphate
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Molecular Formula
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C16H28N2O4.H3PO4
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Molecular Weight
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410.4
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CAS No.
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204255-11-8
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Quality Standard
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99% up, medical grade
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Appearance
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White powder
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COA of Oseltamivir Phosphate
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Test Item
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Specification
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Results
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Appearance
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White to off-white crystalline powder
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White crystalline powder
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Specific rotation
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-30.7o ~ -32.6 o
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-31.4 o
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Identification:
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IR: Spectrum of the sample corresponds to that of reference standard.
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Conform
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HPLC: The retention time of major peak of test solution should correspond to that of comparison solution.
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Conform
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Related substances
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Impurity I NMT 0.1%
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0.01%
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Impurity II NMT 0.1%
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ND
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Impurity III NMT 0.1%
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0.04%
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Impurity IV NMT 0.1%
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0.01%
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Each of unspecified impurity NMT 0.1%
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0.05%
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Total impurities NMT 0.5%
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0.1%
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Related solvents
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Acetone NMT 5000ppm
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81ppm
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Ethanol NMT 5000ppm
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ND
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Dichloromethane NMT 600ppm
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ND
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Ethyl acetate NMT 5000ppm
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ND
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n-Heptane NMT 5000ppm
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ND
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Toluene NMT 890ppm
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ND
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Water
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NMT 0.5%
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0.3%
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Heavy metals
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NMT 10ppm
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Conform
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Assay
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98.0% ~ 101.5% (on anhydrous basis)
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99.4%
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Conclusion
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The product conforms to the above specifications
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Funtion of Oseltamivide phosphate
Oseltamivide phosphate is rapidly metabolized to oseltamivir carboxylate by absorption through the gastrointestinal tract and at least 75% of the oral dose is involved in systemic circulation in the form of oseltamivir carboxylate.
The active ingredient Is a potent and unique neuraminidase inhibitor that acts on all aspects of influenza virus infection andprevents the replication of all clinically relevant strains of influenza A or B viruses. In vitro in very low nanomolar concentrations that have inhibitory effect.
The active metabolite was observed to inhibit the growth of influenza virus in vitro and it was also observed in vivo to inhibit the replication and pathogenicity of influenza virus.
Oseltamivide phosphate reduces the spread of influenza A or B viruses by inhibiting the release of the virus from the infected cells. |
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