Complaint
| Items | Standard | Results | |
| Characters | Description | White or off-white powder.Odorless. | White powder.Odorless |
| ∗Slightly hygroscopy. | ------ | ||
| ∗Solubility | Freely soluble in methanol and ethanol,sparingly soluble in ethyl acetate,slightly soluble in dichloromethane,practically insoluble in water. | ------ | |
| Identification | 1)Infrared absorption spectrophotometry: corresponds to the reference standard. | Conform | |
| 2)The retention time of the major peak in the chromatogram of the assay preparation corresponds to that of the standard preparation,as obtained in the assay. | Conform | ||
| Water(KF) | ≤2.0% | 0.3% | |
| Absorbance | ≤0.02(λ=420nm,C=0.05g/ml,L=1cm) | <0.01 | |
| Residue on ignition | ≤0.1% | <0.1% | |
| D-Valsartan(HPLC) | ≤1.0% | 0.49% | |
| Related substances(HPLC) | Butyryl-Valsartan≤0.2% | 0.02% | |
| Benzyl-Valsartan≤0.1% | <LOD(LOD:0.02%) | ||
| Any other individual impurity≤0.10% | 0.04% | ||
| Total impurities excluding D-Valsartan≤0.3% | 0.08% | ||
| Residual solvents(GC) | Ethanol≤5000ppm | <LOQ(LOQ:5ppm) | |
| Ethyl acetate≤5000ppm | 3114ppm | ||
| Toluene ≤890ppm | 17ppm | ||
| Genotoxic impurity | N-Nitrosodimethylamine(NDMA)≤0.300ppm | N.D | |
| N-Nitrosodiethylamine(NDEA)≤0.082ppm | N.D | ||
| Assay (HPLC) | 98.0%-102.0% (calculated on anhydrous,solvent-free basis) | 99.3% | |
