Customization: | Available |
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Powder: | Yes |
Customized: | Customized |
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Product Name | Valsartan | |||
Reference | USP | |||
Test Items | Specifications | Results | ||
Characters | Description | White or off-white powder. Odorless. | White powder. Odorless | |
*Slightly hygroscopy. | Conform | |||
*Solubility | Freely soluble in ethanol, sparingly soluble in ethyl a'cetate, slightly soluble in dichloromethan'e, practically insoluble in water | Conform | ||
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% | 0.22% | ||
Related substances (HPLC) | Butyryl-Valsartan ≤0.2% | 0.01% | ||
Benzyl-Valsartan ≤0.1% | <LOD(LOD:0.02%) | |||
Any other individual impurity≤0.10% | 0.03% | |||
Total impurities excluding D-Valsartan≤0.3% | 0.06% | |||
Residual solvents (GC) | Ethanol≤5000ppm | <LOD(LOD:2ppm) | ||
Ethyl a'cetate≤5000ppm | 3149ppm | |||
Toluen'e≤890ppm | 19ppm | |||
Assay (HPLC) | 98.0-102.0% (calculated on anhydrous,solvent-free basis) | 100.7% | ||
Conclusion | Complies with USP |