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| EINECS编号 | |
| 英文名称 | Valsartan |
| 外观 | 白色晶体 |
| 纯度 | 99% |
| CAS编号 | 137862-53-4 |
| 别名 | 丙戊沙坦 |
| 保质期 | 12月 |
| 分子式 | C24H29N5O3 |
| 质量标准 | 99% |
Test Items | Specifications | Results |
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. | ||
