Testing items
Testing criteria
Inspection results
Appearance
White or quasi-white crystalline powder
White crystalline powder
Solubility
Water and methanol are soluble
DMF is slightly soluble ether is insoluble
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%
Residual solvents
Ethanol≤0.5%
0.08%
Dichloromethane ≤0.05%
Toluene≤0.10%
n-Heptane≤0.5%
0.02%
Water
≤0.5%
0.13%
Assay
98.5%~102.0%
99.80%
Conclusion
Lot meets specification
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