Ibutilide is a synthetic class III antiarrhythmic active pharmaceutical ingredient (API) used for the pharmacological conversion of certain cardiac arrhythmias. It is a methanesulfonamide derivative that primarily prolongs cardiac repolarization and the action potential duration.
Ibutilide has the molecular formula C20H36N2O3S and a molecular weight of 384.58 g/mol. Its CAS Number is 122647-32-9.
Ibutilide is an antiarrhythmic agent belonging to the class III category. It is particularly associated with the acute conversion of atrial fibrillation and atrial flutter to normal sinus rhythm.
Unlike many conventional class III antiarrhythmics, ibutilide primarily acts by prolonging cardiac repolarization through effects on cardiac ion currents.
Ibutilide prolongs the cardiac action potential and refractory period. Its principal electrophysiological activity is associated with enhancement of a slow inward sodium current and inhibition of certain potassium currents involved in cardiac repolarization.
The resulting prolongation of the action potential and effective refractory period can facilitate conversion of atrial fibrillation or atrial flutter to sinus rhythm.
Ibutilide API is used in the development and manufacture of:
Ibutilide is manufactured through controlled chemical synthesis followed by purification, crystallization and drying. Pharmaceutical-quality testing is performed to confirm identity, purity and consistency.
Quality control may include identification, assay, related substances, water content, residue on ignition, elemental impurities and residual solvents according to the applicable approved specification.
Ibutilide is generally supplied as a white to off-white crystalline solid or powder. It is a polar sulfonamide-containing compound and is suitable for formulation as the corresponding pharmaceutical salt where applicable.
Ibutilide 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:
Ibutilide is a class III antiarrhythmic API with established electrophysiological activity for the acute conversion of atrial fibrillation and atrial flutter. Its ability to prolong cardiac repolarization makes it an important active ingredient for cardiovascular pharmaceutical development.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 3.0 – 5.0 |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 1.0% |
| Melting Point | Approximately 156–160°C |