Description
USAGE:
Tolvaptan (INN), also known as OPC-41061, is a selective, competitive vasopressin receptor 2 antagonist used to treat hyponatremia (low blood sodium levels) associated with congestive heart failure, cirrhosis, and the syndrome of inappropriate antidiuretic hormone (SIADH).
| Product name | Tolvaptan | ||
| Reference | USDMF standard | ||
| Test Items | Specifications | Results | |
| Appearance | White to off-white crystalline powder | Off-white crystalline powder | |
| Solubility | Sparingly soluble in methanol, practically insoluble in water. | Conforms | |
| Identification | 1) The infrared absorption spectrum is in accordance with the spectrum obtained with Tolvaptan reference standard. | Conforms | |
| 2) The retention time of the major peak in the chromatogram obtained with test solution is in accordance with that in the chromatogram obtained with standard solution as Assay test. | Conforms | ||
| XRPD | The XRPD spectrum of the sample is in accordance with the spectrum obtained with Tolvaptan RS | Conforms | |
| Water | ≤0.5% | 0.2% | |
| Residue on ignition | ≤0.1% | <0.1% | |
| Assay (HPLC) | 98.0%-102.0%(On anhydrous basis) | 99.5% | |
| Related Substances (HPLC) | Impurity I≤0.15% | 0.08% | |
| Any unspecified impurity≤0.10% | 0.05% | ||
| Total impurities≤0.5% | 0.18% | ||
| Residual Solvents (GC) | Acetonitrile≤410ppm | <LOD(LOD=21ppm) | |
| Dichloromethane≤600ppm | <LOD(LOD=25ppm) | ||
| Ethanol≤5000ppm | <LOD(LOD=25ppm) | ||
| Methanol≤3000ppm | <LOD(LOD=16ppm) | ||
| MTBE≤5000ppm | <LOD(LOD=2ppm) | ||
| Residual reagent | Sn≤I0ppm | <LOD(LOD=0.5ppm) | |
| Triethylamine≤320ppm | <LOD(LOD=9ppm) | ||
| Conclusion | Complies with USDMF standard | ||
