Ibutilide Fumarate is the fumarate salt of ibutilide, a Class III antiarrhythmic active pharmaceutical ingredient used for the acute pharmacological conversion of certain atrial arrhythmias. It acts primarily by prolonging cardiac repolarization and increasing the cardiac action potential duration.
Ibutilide Fumarate has the molecular formula C24H40N2O7S and a molecular weight of 500.65 g/mol. Its CAS Number is 122647-33-0.
Ibutilide Fumarate is a synthetic antiarrhythmic compound belonging to the Class III antiarrhythmic group. The fumarate salt provides the pharmaceutical salt form of ibutilide used in drug development and formulation.
The active ingredient is associated primarily with the acute conversion of atrial fibrillation and atrial flutter to normal sinus rhythm.
Ibutilide prolongs cardiac action potential duration and the effective refractory period. Its electrophysiological activity is associated with enhancement of a slow inward sodium current and inhibition of cardiac potassium currents involved in repolarization.
This prolongation of repolarization can facilitate conversion of atrial fibrillation or atrial flutter to sinus rhythm.
Ibutilide Fumarate API is used for the development and manufacture of:
Ibutilide Fumarate is manufactured through controlled chemical synthesis followed by purification and fumarate salt formation. The resulting API is subjected to pharmaceutical quality testing for identity, potency, purity and physicochemical characteristics.
Typical quality evaluation may include identification, assay, related substances, water content, residual solvents, elemental impurities and other applicable tests according to the approved product specification.
Ibutilide Fumarate is generally supplied as a white to off-white crystalline solid or powder. The fumarate salt has greater polarity than the free base and is suitable for pharmaceutical formulation development.
Ibutilide Fumarate should be stored in a tightly closed container, protected from excessive moisture, heat and direct light. Storage conditions should comply with the manufacturer's current CoA, SDS and validated stability requirements.
Depending on the intended pharmaceutical application, documentation may include:
Ibutilide Fumarate is a pharmaceutical salt form of the Class III antiarrhythmic ibutilide. It is primarily associated with acute conversion of atrial fibrillation and atrial flutter and is relevant to cardiovascular pharmaceutical formulation and research.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 3.0% |
| Residue on Ignition | NMT 0.5% |
| pH (1% Solution) | 2.5 – 4.5 |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 3.0% |
| Melting Point | Approximately 175–180°C (decomposition) |