Description
USAGE:
Valticetine hydrobromide is considered to be a novel multi-model antidepressant drug. In vitro studies have shown that it can antagonize 5-HT3, 5-HT7 and 5-HT1D receptors, activate 5-HT1A receptors, and partially activate 5- HT1B receptors and inhibit 5-HT transport.
Valticetine hydrobromide is considered to be a novel multi-model antidepressant drug. In vitro studies have shown that it can antagonize 5-HT3, 5-HT7 and 5-HT1D receptors, activate 5-HT1A receptors, and partially activate 5- HT1B receptors and inhibit 5-HT transport.
For the treatment of mild to moderate or severe depression Neurogenic and Reactive Depression Physiotherapy, especially gastrointestinal distress Depression Anxiety Depression in patients with alcohol dependence during withdrawal.
| Produet.Name | Vortioxetine Hydrobromide | ||
| Reference | EDMF standard | ||
| Test Items | Specifications | Results | |
| Appearance | White to slightly beige crystalline powder | White crystalline powder | |
| Identification | 1) Infrared absorption spectrum corresponds to the spectrum obtained with Vortioxetine Hydrobromide RS. | Conforms | |
| 2) The retention time of the major peak in the chromatogram of the Sample solution corresponds to that in the chromatogram of the Standard solution, as obtained in the Assay. | Conforms | ||
| 3) It gives reactions to bromides | Conforms | ||
| Water | ≤0.5% | 0.1% | |
| Sulfated ash | ≤0.1% | <0.1% | |
| Related substances (HPLC) | Sulfoxide impurity≤0.15% | N.D | |
| Phenethyl impurity≤0.15% | <RL(0.05%) | ||
| Any unspecified impurity≤0.10% | N.D | ||
| Total impurities≤0.5% | <RL | ||
| Assay (HPLC) | 98.0%~102.0%(Calculated on anhydrous and solvent-free basis) | 100.1% | |
| Bromide content | 20.0%~22.1 %(Calculated on anhydrous basis) | 21.0% | |
| Residual solvents (GC) | 2-Propanol≤5000ppm | <LOQ(156ppm) | |
| tert-Butylmethyl ether≤5000ppm | 1109ppm | ||
| Toluene≤890ppm | N.D | ||
| Methanol≤3000ppm | <LOQ(300ppm) | ||
| Residual reagent | Pd≤10ppm | <LOD(1ppm) | |
| Conclusion | Complies with EDMF standard | ||
