Mexiletine API is an orally active Class IB antiarrhythmic agent structurally related to lidocaine. It is a small-molecule active pharmaceutical ingredient that acts primarily by blocking voltage-gated sodium channels, reducing abnormal electrical activity in cardiac tissue. Mexiletine is used clinically for the management of documented life-threatening ventricular arrhythmias, particularly sustained ventricular tachycardia.
Chemically, Mexiletine is 1-(2,6-dimethylphenoxy)propan-2-amine, with the molecular formula C₁₁H₁₇NO and molecular weight 179.26 g/mol. Its CAS Number is 31828-71-4. The hydrochloride salt, commonly used in pharmaceutical dosage forms, has a separate CAS Number of 5370-01-4 and molecular weight 215.72 g/mol.
Mexiletine is an important pharmaceutical compound for cardiovascular drug development and is also structurally and pharmacologically related to lidocaine. Its sodium-channel-blocking activity decreases abnormal impulse conduction and suppresses certain ventricular arrhythmias.
Mexiletine API is suitable for pharmaceutical formulation development, analytical research, drug-product manufacturing and other qualified pharmaceutical applications requiring controlled active ingredient quality.
Mexiletine is a primary amino compound and aromatic ether classified pharmacologically as a Class IB antiarrhythmic drug. It is chemically related to lidocaine and produces its principal pharmacological effect through sodium-channel blockade.
Mexiletine reduces the inward sodium current in excitable cells. In cardiac tissue, this action affects the rate of depolarization and electrical impulse propagation, helping suppress abnormal ventricular electrical activity.
The free base Mexiletine has CAS 31828-71-4, while Mexiletine Hydrochloride is the hydrochloride salt with CAS 5370-01-4.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| 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 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |