Description
Function
Valsartan is used to treat high blood pressure, congestive heart failure, and to reduce death for people with left ventricular dysfunction after having had a heart attack.
Valsartan is used to treat high blood pressure, congestive heart failure, and to reduce death for people with left ventricular dysfunction after having had a heart attack.
Valsartan blocks the actions of angiotensin II, which include constricting blood vessels and activating aldosterone, to reduce blood pressure.The drug binds to angiotensin type I receptors (AT1), working as an antagonist. This mechanism of action is different than the ACE inhibitor drugs, which block the conversion of angiotensin I to angiotensin II. Since valsartan acts at the receptor, it can provide more complete angiotensin II antagonism since angiotensin II is generated by other enzymes as well as ACE. Also, valsartan does not affect the metabolism of bradykinin like ACE inhibitors do.
| 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 methanol and ethanol, sparingly soluble in ethyl acetate, slightly soluble in dichloromethane, 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 acetate≤5000ppm | 3149ppm | |||
| Toluene≤890ppm | 19ppm | |||
| Assay (HPLC) | 98.0-102.0% (calculated on anhydrous,solvent-free basis) | 100.7% | ||
| Conclusion | Complies with USP | |||
