Sotalol is a non-selective antagonist of β-adrenergic receptors (β-ARs; IC50s = 8.9 and 5.2 μM for β1- and β2-ARs, respectively) and a class III antiarrhythmic agent. It decreases delayed outward potassium currents (IK) in guinea pig ventricular cells and prolongs action potential duration in electrically stimulated isolated guinea pig papillary muscles when used at a concentration of 100 μM. Sotalol decreases heart rate and increases blood pressure and the cardiac functional refractory period (FRP) in a canine model of ventricular tachycardia induced by programmed electrical stimulation (PES). Formulations containing sotalol have been used in the treatment of ventricular arrhythmias and maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL).
Sotalol hydrochloride is used as a potent beta adrenergic antagonist, prolongs the action potential and increases the refractory period. Sotalol hydrochloride is also considered a non-selective β blocker and a potassium channel blocker with an IC50 of 43 μM.
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Items | Standards | Results | |
Appearance | White or off-white solid powder | Complies | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Solubility | Soluble in DMF, sparingly soluble in THF,insoluble in water | Complies | |
Polymorphic Form | Polymorphic form 1 | Complies | |
Melting Point | 211ºC~216ºC | 212.8ºC~214.9ºC | |
Water Content | ≤ 0.50% | 0.10% | |
Heavy Metals | ≤ 20ppm | Complies | |
Residue on Ignition | ≤ 0.20% | 0.09% | |
Related Substance | Any single impurity: ≤0.10% | 0.06% | |
Total Impurities: ≤1.00% | 0.16% | ||
Assay (on the anhydrous basis) | 98.0%~102.0% | 99.94% | |
Particle Size | D90: ≤100µm | Complies | |
Reference Standard | In-house Standard |
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