Nicardipine Hydrochloride is a synthetic dihydropyridine calcium channel blocker and active pharmaceutical ingredient (API). It inhibits calcium ion influx through L-type calcium channels and produces vasodilation, particularly in arterial vascular smooth muscle.
Nicardipine Hydrochloride is used in pharmaceutical formulations for the management of hypertension and in clinical settings requiring controlled reduction of blood pressure. It is also used in pharmaceutical research and formulation development. Official FDA labeling identifies Nicardipine Hydrochloride as a calcium ion influx inhibitor.
Nicardipine Hydrochloride is an established cardiovascular pharmaceutical API used in the development and manufacture of antihypertensive formulations.
USP defines Nicardipine Hydrochloride as containing NLT 98.0% and NMT 102.0% of nicardipine hydrochloride, calculated on the dried basis.
CAS Number: 54527-84-3
Molecular Formula: C₂₆H₂₉N₃O₆·HCl
Molecular Weight: 515.99 g/mol
Free Base CAS: 55985-32-5
Free Base Molecular Weight: 479.53 g/mol
Chemical Name: 2-(Benzylmethylamino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride
Drug Class: Dihydropyridine Calcium Channel Blocker
Therapeutic Class: Antihypertensive
Therapeutic Area: Cardiovascular
Molecule Type: Synthetic Small Molecule
USP confirms the molecular formula, molecular weight and CAS information for Nicardipine Hydrochloride.
Nicardipine Hydrochloride is a calcium channel blocker that inhibits calcium influx through L-type calcium channels.
Its pharmacological effects include:
Official labeling describes Nicardipine Hydrochloride as a calcium ion influx inhibitor or slow-channel blocker.
Nicardipine Hydrochloride API is relevant to:
Nicardipine is used as an antihypertensive agent because of its ability to produce arterial vasodilation through calcium-channel blockade.
It is available in both oral and intravenous pharmaceutical formulations, with intravenous Nicardipine Hydrochloride used when controlled blood-pressure reduction is clinically required.
Nicardipine belongs to the 1,4-dihydropyridine calcium channel blocker class.
Its vascular effects are primarily associated with inhibition of calcium entry into vascular smooth muscle cells, resulting in relaxation and reduced vascular resistance.
Nicardipine Hydrochloride is described as a pale greenish-yellow crystalline powder. FDA labeling reports a melting point of approximately 169°C, while other current labeling gives a range of approximately 167–171°C. It is soluble in methanol, sparingly soluble in ethanol and slightly soluble in acetone, chloroform and water.
Nicardipine Hydrochloride is:
These solubility characteristics are reported in official product labeling.
A controlled Nicardipine Hydrochloride API manufacturing process may involve:
Typical Nicardipine Hydrochloride API testing may include:
The current USP monograph establishes an assay range of 98.0–102.0% on the dried basis.
Store Nicardipine Hydrochloride API in an airtight container protected from light under controlled pharmaceutical storage conditions.
Nicardipine Hydrochloride is light-sensitive, and commercial technical information recommends cool, dark storage.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |