奧司他韦（Base）

Appearance

White or quasi-white crystalline powder

White crystalline powder

Solubility

Soluble in alcohol solvents

Conforms

Specific Rotation

-30.7°~-32.6°

-31.7°

Idetification

The retention time of the main peak of the test sample is the same as that of the test sample.

Conforms

The test sample is consistent with the nuclear magnetic resonance (NMR) of the test sample.

Conforms

Palladium content

≤0.001%

0.0002%

Relevant substances

Impurity I≤0.1%

N.D

Impurity II ≤0.1%

0.003%

Impurity III ≤0.2%

N.D

Impurity IV ≤0.1%

0.03%

Any unspecified indiuidual impurity≤0.1%

0.04%

Total impunities≤0.5%

0.16%

Purity of HPLC

99.84%

Water

≤0.5%

0.13%

Assay

98.5%~102.0%

99.80%

Conclusion

Lot meets specification