Manidipine is a dihydropyridine calcium channel blocker (CCB) used primarily as an antihypertensive medicine. It lowers blood pressure by inhibiting the influx of calcium ions through L-type calcium channels in vascular smooth muscle, resulting in vasodilation and reduced peripheral vascular resistance.
Manidipine is particularly characterized by its potent vasodilatory activity and is used in pharmaceutical formulations for the management of essential hypertension.
Manidipine is a synthetic dihydropyridine derivative with the molecular formula C35H38N4O6 and a molecular weight of approximately 610.71 g/mol. Its CAS Number is 89226-75-5.
The molecule contains a 1,4-dihydropyridine core together with substituted ester and piperazine-containing groups that contribute to its pharmacological activity and physicochemical properties.
Manidipine selectively inhibits L-type calcium channels, particularly in vascular smooth muscle cells. Blocking calcium influx reduces intracellular calcium availability required for smooth-muscle contraction.
This produces relaxation of arterial vascular smooth muscle, leading to peripheral vasodilation and reduction in systemic vascular resistance, thereby lowering blood pressure.
Manidipine is primarily used in pharmaceutical formulations for the treatment of essential hypertension.
It may be formulated as oral tablets and other pharmaceutical dosage forms according to applicable regulatory requirements.
Manidipine API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residual solvents, elemental impurities and other applicable quality attributes.
Chromatographic and spectroscopic techniques may be used for identity, assay and purity determination. Appropriate controls should be established for process-related impurities, degradation products and residual solvents.
Acceptance criteria should be based on the applicable manufacturer's drug-substance specification, Certificate of Analysis and relevant pharmacopoeial and regulatory requirements.
Manidipine should be stored in a tightly closed pharmaceutical-grade container under controlled conditions. It should be protected from excessive heat, moisture and direct light.
Specific storage and transportation requirements should follow the applicable manufacturer's approved specification.
Manidipine API may be supplied for qualified pharmaceutical manufacturing, formulation development, analytical and research applications, subject to applicable quality and regulatory requirements.
Manidipine API is available for qualified pharmaceutical development and manufacturing requirements subject to applicable quality and regulatory standards. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.5 – 6.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 2.0% |