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Product Information
Product name
Oseltamivir Phosphate
Molecular Formula
C16H28N2O4.H3PO4
Molecular Weight
410.4
CAS No.
204255-11-8
Quality Standard
99% up, medical grade
Appearance
White powder
COA of Oseltamivir Phosphate
Test Item
Specification
Results
Appearance
White to off-white crystalline powder
White crystalline powder
Specific rotation
-30.7o ~ -32.6 o
-31.4 o
Identification:
IR: Spectrum of the sample corresponds to that of reference standard.
Conform
HPLC: The retention time of major peak of test solution should correspond to that of comparison solution.
Conform
Related substances
Impurity I NMT 0.1%
0.01%
Impurity II NMT 0.1%
ND
Impurity III NMT 0.1%
0.04%
Impurity IV NMT 0.1%
0.01%
Each of unspecified impurity NMT 0.1%
0.05%
Total impurities NMT 0.5%
0.1%
Related solvents
Acetone NMT 5000ppm
81ppm
Ethanol NMT 5000ppm
ND
Dichloromethane NMT 600ppm
ND
Ethyl acetate NMT 5000ppm
ND
n-Heptane NMT 5000ppm
ND
Toluene NMT 890ppm
ND
Water
NMT 0.5%
0.3%
Heavy metals
NMT 10ppm
Conform
Assay
98.0% ~ 101.5% (on anhydrous basis)
99.4%
Conclusion
The product conforms to the above specifications
Usage
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.