DC5305
654671-77-9
C16H15F6N5O.H3PO4.H2O
Sitagliptin phosphate
Index Name | Specifications |
Appearance | White or off-white crystal |
Purity | 98.0% min |
High-performance liquid chromatograph | The retention time of test sample major peak complies to reference standard |
IR-infrared spectrum | The IR absorption spectrum of the sample shall be concordant with that of standard spectrum |
Water | 3.3%-4.4% |
Residue on ignition | 0.1% max |
Sulphate | 0.02% max |
Chloride | 0.05% max |
Related impurity | Total impurities 1.0% max |
Single impurity 0.5% max | |
Ethyl acetate | 0.5% max |
Heavy metals | 20 ppm max |
Index Name | Specifications |
Appearance | White or off-white crystal |
Purity | 98.0% min |
High-performance liquid chromatograph | The retention time of test sample major peak complies to reference standard |
IR-infrared spectrum | The IR absorption spectrum of the sample shall be concordant with that of standard spectrum |
Water | 3.3%-4.4% |
Residue on ignition | 0.1% max |
Sulphate | 0.02% max |
Chloride | 0.05% max |
Related impurity | Total impurities 1.0% max |
Single impurity 0.5% max | |
Ethyl acetate | 0.5% max |
Heavy metals | 20 ppm max |
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