|
Item |
Specification |
Result |
|
Appearance |
White or off-white powder |
Conforms |
|
Water (KF) |
≤2.0% |
0.25% |
|
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% |
0.20% |
|
Related substances |
Butyryl-Valsartan ≤0.2% |
0.02% |
|
Related substances |
Benzyl-Valsartan ≤0.1% |
<LOD(LOD:0.02%) |
|
Any other individual impurity≤0.10% |
0.035% |
|
|
Total impurities excluding D-Valsartan≤0.3% |
0.055% |
|
|
Residual solvents(GC) |
Ethanol≤5000ppm |
<LOD(LOD:2ppm) |
|
Ethyl acetate≤5000ppm |
3150ppm |
|
|
Toluene≤890ppm |
25ppm |
|
|
Assay(Calculated on dried basis) |
98.0-102.0%) |
100.5% |