Imidapril is an orally active angiotensin-converting enzyme (ACE) inhibitor and active pharmaceutical ingredient used primarily in the management of hypertension and certain cardiovascular conditions. It is a prodrug that is converted in the body to its active metabolite, imidaprilat.
Imidapril has the molecular formula C20H27N3O6 and a molecular weight of approximately 405.45 g/mol. Its CAS Number is 89396-94-1.
Imidapril belongs to the ACE inhibitor class of cardiovascular medicines. Following oral administration, imidapril is hydrolyzed to imidaprilat, which inhibits angiotensin-converting enzyme.
This reduces the formation of angiotensin II and decreases aldosterone secretion, resulting in reduced vasoconstriction and lower blood pressure.
Imidapril is converted to imidaprilat, which inhibits ACE. ACE inhibition reduces the conversion of angiotensin I to angiotensin II.
The resulting reduction in angiotensin II promotes vasodilation and decreases aldosterone-mediated sodium and water retention, contributing to a reduction in blood pressure.
Imidapril API is used in the development and manufacture of:
Imidapril is manufactured through controlled chemical synthesis followed by purification, crystallization and drying. Pharmaceutical quality control typically evaluates identity, assay, related substances, water content, optical properties and other applicable quality attributes.
Imidapril is generally supplied as a white to off-white crystalline powder. It is sparingly soluble in water and soluble in certain organic solvents.
Imidapril should be stored in a tightly closed container, protected from excessive moisture, heat and direct light. Storage conditions should follow the manufacturer's current CoA, SDS and validated stability requirements.
Depending on the intended pharmaceutical application, documentation may include:
| 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% |
| pH (1% Solution) | 4.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 2.0% |