|
ITEMS |
SPECIFICATION |
RESULTS |
|
Appearance |
White powder |
White powder |
|
Identification |
IR |
complies |
|
|
HPLC |
complies |
|
Water |
≤0.5% |
0.30% |
|
Residue on ignition |
≤0.1% |
0.07% |
|
Residual Solvents |
Ethanol ≤0.5% |
0.040% |
|
|
Dichloromethane ≤0.06% |
0.017% |
|
Related impurity |
Any single Impurity≤0.1% |
0.02% |
|
|
Total Impurities≤0.5% |
0.03% |
|
Assay(HPLC) |
98.0%~102.0% |
99.5% |
|
Storage Condition |
Store in a tightly closed container and protected from sunlight. |
|
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