中文名称：缬沙坦
英语名称： Valsartan
|
Appearance |
white to almost white crystalline powder |
White crystalline powder |
|
Identification IR HPLC |
Must conform to reference standard Must conform to reference standard |
Conforms Conforms |
|
Absorbance |
NMT0.02 |
0.008 |
|
Water |
NMT 2.0% |
0.76% |
|
Residue on Ignition |
NMT0.1% |
0.04% |
|
Heavy Metals |
NMT 0.001% |
﹤0.001% |
|
Related compounds R-isomer Compound B Compound C Any other individual impurity Total impurities (excluding R-isomer) |
NMT 1.0% NMT 0.2% NMT 0.1% NMT 0.1% NMT 0.3% |
0.60% 0.03% Conforms 0.04% 0.15% |
|
Residual solvents Ethyl acetate Dichloromethane Methanol N,N-Dimethylformamidc |
NMT 0.5% NMT 0.06% NMT 0.3% NMT 0.088% |
0.20% Conforms Conforms 0.008% |
|
Assay (HPLC) |
98.0-102.0% |
99.4% |
|
Conclusion:It conforms to USP31. |
