Nisoldipine is a synthetic 1,4-dihydropyridine calcium channel blocker and pharmaceutical active ingredient. It primarily acts on vascular smooth muscle by inhibiting L-type calcium channels, reducing calcium influx and producing vasodilation. Nisoldipine is associated with the management of hypertension and cardiovascular conditions requiring calcium-channel blockade.
Nisoldipine is a small-molecule API with the molecular formula C₂₀H₂₄N₂O₆ and molecular weight 388.4 g/mol.
Nisoldipine is a specialized cardiovascular pharmaceutical API used in the development and manufacture of pharmaceutical formulations.
Important quality attributes include identity, assay, related substances, water content, residual solvents, elemental impurities, stereochemical/solid-state characteristics and other applicable pharmaceutical quality parameters.
CAS Number: 63675-72-9
Molecular Formula: C₂₀H₂₄N₂O₆
Molecular Weight: 388.40 g/mol
Chemical Name: 3-O-methyl 5-O-(2-methylpropyl) 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
IUPAC Name: Methyl 2-methylpropyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
Drug Class: Dihydropyridine Calcium Channel Blocker
Therapeutic Class: Antihypertensive / Cardiovascular Agent
Therapeutic Area: Cardiovascular
Molecule Type: Synthetic Small Molecule
Development Code: BAY K 5552
PubChem confirms CAS 63675-72-9, molecular formula C₂₀H₂₄N₂O₆ and molecular weight 388.4 g/mol.
Nisoldipine acts primarily by inhibiting L-type calcium channels in vascular smooth muscle.
Its pharmacological effects include:
Nisoldipine is classified as a dihydropyridine calcium channel blocker.
Nisoldipine API is relevant to:
Nisoldipine is used as a calcium channel blocker in the management of hypertension. It has also been associated with treatment of angina pectoris in pharmacological references.
The current approved therapeutic use should always be determined according to the applicable regulatory labeling and jurisdiction.
Nisoldipine is described as a yellow crystalline powder or yellow crystalline substance. It is practically insoluble in water and soluble in organic solvents including ethanol; some official labeling also reports solubility in acetone and methanol.
Nisoldipine is practically insoluble in water and soluble in ethanol. Official labeling also describes solubility in acetone and methanol.
A controlled Nisoldipine API manufacturing process may involve:
Typical Nisoldipine API testing may include:
| 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 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |