Propafenone Impurities

General Information

Propafenone Impurities and Propafenone

Daicel Pharma offers Propafenone impurity standards, which include Propafenone EP impurity A and Propafenone EP impurity C. These impurities are crucial to assess Propafenone purity, quality, and safety. Furthermore, Daicel Pharma provides custom synthesis of Propafenone impurities and delivers them globally.

Propafenone [CAS: 54063-53-5] is an aromatic ketone structure that belongs to the class 1C antiarrhythmic drugs and exhibits local anesthetic properties. Propafenone manages supraventricular and ventricular arrhythmias. It functions primarily as an anti-arrhythmia drug.

Propafenone: Use and Commercial Availability

Propafenone is prescribed to patients without structural heart disease to delay the reoccurrence of paroxysmal atrial fibrillation/flutter (PAF) associated distressing symptoms. It manages life-threatening documented ventricular arrhythmias, including sustained ventricular tachycardia. This drug is available under various brands Rythmol and Rythmol SR.

Propafenone Structure and Mechanism of Action 

Impurities The chemical name of Propafenone is 1-[2-[2-Hydroxy-3-(propylamino)propoxy]phenyl]-3-phenyl-1-propanone. Its chemical formula is C₂₁H₂₇NO₃, and its molecular weight is approximately 341.4 g/mol.

Propafenone has a direct stabilizing action on myocardial membranes. It depresses triggered activity and reduces spontaneous automaticity.

Propafenone Impurities and Synthesis 

Impurities in Propafenone can form during its manufacture¹ and storage, impacting its purity and efficacy. During the synthetic process, it is critical to guarantee the purity of the starting components while also managing reaction conditions to minimize impurity production. Impurities in Propafenone can be due to side reactions, incomplete reactions, or contaminants in the starting ingredients. Adequate purifying processes, such as crystallization and distillation, eliminate these impurities and generate a pure version of Propafenone.

Daicel Pharma offers a Certificate of Analysis (CoA) from a cGMP-compliant analytical facility for Propafenone impurity standards such as Propafenone EP impurity A and Propafenone EP impurity C. At Daicel Pharma, we have a cGMP-certified analytical laboratory that provides the CoA, which includes thorough characterization data including 1H NMR, 13C NMR, IR, MASS, and HPLC purity². On request, we give more characterization details, such as those for 13C-DEPT. We offer Propafenone impurities and labeled compounds to evaluate generic Propafenone. Furthermore, we offer highly Propafenone-d5 Hydrochloride, a pure deuterium-labeled Propafenone compound that supports bioanalytical research and Bioavailability/Bioequivalence (BA/BE) research.