China Antihypertensive Drugs Valsartan CAS No 137862-53-4, Find details about China Valsartan, 137862-53-4 from Antihypertensive Drugs Valsartan CAS No 137862-53-4
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% |