Nitrendipine is a synthetic 1,4-dihydropyridine calcium channel blocker used as an active pharmaceutical ingredient in antihypertensive drug formulations. It primarily acts by inhibiting L-type calcium channels in vascular smooth muscle, resulting in relaxation of blood vessels and reduction of peripheral vascular resistance.
Nitrendipine is a well-characterized small-molecule API used in pharmaceutical formulation development and cardiovascular research.
Nitrendipine is a specialized cardiovascular pharmaceutical API used for the development and manufacture of oral antihypertensive formulations.
Important quality attributes include identity, assay, related substances, water content, sulfated ash, optical rotation where applicable, melting range and residual solvents.
CAS Number: 39562-70-4
Molecular Formula: C18H20N2O6
Molecular Weight: 360.36 g/mol
Chemical Name: 3-Ethyl 5-methyl (4RS)-2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
Drug Class: Dihydropyridine Calcium Channel Blocker
Therapeutic Class: Antihypertensive
Therapeutic Area: Cardiovascular
Molecule Type: Synthetic Small Molecule
Nitrendipine blocks L-type voltage-dependent calcium channels, predominantly affecting calcium influx into vascular smooth muscle.
Its pharmacological effects include:
Nitrendipine API is used in pharmaceutical development for:
Nitrendipine is particularly relevant to hypertension management because its calcium-channel-blocking activity produces arterial vasodilation.
As a dihydropyridine calcium channel blocker, its principal pharmacological effect is on vascular smooth muscle rather than cardiac conduction.
Nitrendipine is generally described as a yellow crystalline powder. It is practically insoluble in water and soluble in certain organic solvents. Its physicochemical properties and polymorphic characteristics should be controlled according to the applicable API specification.
A controlled Nitrendipine API manufacturing process may involve:
Typical Nitrendipine API quality-control testing may include:
Nitrendipine is relevant to research involving:
Store Nitrendipine API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light. Final storage conditions should follow validated stability data and the manufacturer's approved specification.
| 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 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | 158–161°C |