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Product name
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Oseltamivir Phosphate
|
|
Molecular Formula
|
C16H28N2O4.H3PO4
|
|
Molecular Weight
|
410.4
|
|
CAS No.
|
204255-11-8
|
|
Quality Standard
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99% up,
medical grade
|
|
Appearance
|
White powder
|
|
COA of Oseltamivir Phosphate
|
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Test Item
|
Specification
|
Results
|
|
Appearance
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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
|
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.
