Fluvastatin is a fully synthetic lipid-lowering agent belonging to the statin class. It is a competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the rate-limiting enzyme involved in hepatic cholesterol biosynthesis. Pharmaceutical products commonly use Fluvastatin Sodium, the sodium salt of fluvastatin.
Fluvastatin Sodium is used as an active pharmaceutical ingredient in medicines designed to reduce elevated levels of LDL cholesterol and total cholesterol and to help manage hyperlipidemia. By inhibiting HMG-CoA reductase, fluvastatin reduces hepatic cholesterol synthesis and promotes increased hepatic uptake of circulating LDL particles.
Fluvastatin is structurally distinct from naturally derived statins because it is a synthetic HMG-CoA reductase inhibitor. The sodium salt is described as a white to pale-yellow, hygroscopic powder that is soluble in water, ethanol and methanol.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.5 – 6.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |