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5 Kilogram |
Negotiable |
Tolvaptan Tolvaptan 98% Tolvaptan API
≥98.0% min
Tolvaptan
Appearance |
A white or off-white crystalline powder |
Identification |
HPLC:Retention time of the major peaks is consistent with the standard preparation as obtained in the assay |
|
IR: The infrared absorption spectrophotometry is accordant with the contrast spectrophotometry |
|
Chloride identification: positive reaction |
PH |
5.5~7.5 |
Melting point |
223~228℃ |
Water |
≤0.5% |
Related substance |
Any individual impurity:≤0.1% Total impurities:≤0.3% |
Residual solvent |
Methyl alcohol ≤0.3% Ethyl alcohol ≤0.5% Dichloromethane ≤0.06% Ethy acetate ≤0.5% Pyridine ≤0.02% |
Chloride |
≤0.014% |
Residue on ignition |
≤0.1% |
Heavy metals |
≤10ppm |
Assay |
98.0~102.0% of Tolyaptan(C26H25CIN2O3) calculated on the dry anhydrous
|
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