Clevidipine is a short-acting dihydropyridine calcium channel blocker used primarily for the rapid reduction of blood pressure in clinical settings. The pharmaceutical active ingredient is commonly supplied as Clevidipine Butyrate.
Clevidipine butyrate has the molecular formula C₂₁H₂₃Cl₂NO₆, molecular weight 456.32 g/mol, and CAS No. 167221-71-8. FDA records identify clevidipine as a racemic substance with no defined stereochemical specification.
FDA describes clevidipine butyrate as practically insoluble in water.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Assay (HPLC) | NLT 99.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 1.0% |