 |
| Menge: | |
|---|---|
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 |