Lercanidipine Hydrochloride is the hydrochloride salt of lercanidipine, a dihydropyridine calcium channel blocker used primarily for the treatment of hypertension. It selectively inhibits L-type calcium channels in vascular smooth muscle, producing arterial vasodilation and reducing peripheral vascular resistance.
Lercanidipine HCl is commonly used as an active pharmaceutical ingredient in oral antihypertensive formulations.
Lercanidipine HCl is a specialized cardiovascular pharmaceutical API manufactured through controlled chemical synthesis, purification and crystallization.
Important quality attributes include identity, assay, related substances, water content, residual solvents, elemental impurities, optical purity, polymorphic form and stability.
CAS Number: 132866-11-6
Molecular Formula: C36H42N2O6·HCl
Molecular Weight: 648.19 g/mol
Drug Class: Calcium Channel Blocker
Pharmacological Class: Dihydropyridine Calcium Channel Blocker
Therapeutic Class: Antihypertensive
Therapeutic Area: Cardiovascular
Lercanidipine selectively blocks L-type calcium channels in vascular smooth muscle.
Reduced calcium entry into vascular smooth muscle cells causes relaxation of arterial smooth muscle, resulting in:
Its vascular selectivity contributes to its antihypertensive activity.
Lercanidipine HCl is primarily used for:
It is generally formulated as an oral tablet and may be used alone or in combination with other antihypertensive medicines according to clinical requirements.
Lercanidipine belongs to the 1,4-dihydropyridine class of calcium channel blockers. It is highly lipophilic and has a prolonged antihypertensive effect, supporting once-daily oral administration in approved formulations.
Typical API manufacturing may involve:
Lercanidipine HCl API quality evaluation may include:
Lercanidipine HCl should be stored in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage conditions should be established through validated stability studies.
Lercanidipine HCl is relevant to research involving:
| 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% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 1.0% |