Testing items
Testing criteria
Inspection results
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.
The test sample is consistent with the nuclear magnetic resonance (NMR) of the test sample.
Palladium content
≤0.001%
0.0002%
Relevant substances
Impurity I≤0.1%
N.D
Impurity II ≤0.1%
0.003%
Impurity III ≤0.2%
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
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