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Procainamide Impurities

Procainamide is an antiarrhythmic medication used to treat and prevent a variety of abnormal heart rhythms (arrhythmias), including:
∙ Ventricular arrhythmias
∙ Atrial fibrillation
∙ Paroxysmal supraventricular tachycardia (PSVT)
It belongs to Class 1A antiarrhythmics and works by blocking sodium channels, which slows conduction in cardiac tissues and prolongs the action potential.
Procainamide is typically administered:
∙ Intravenously (IV) in emergency or hospital settings
∙ Orally (as tablets or capsules) for chronic use (less common today)

Structure

Product Name

CAS No.

Cat No.

Action

Procainamide Hydrochloride Impurity

Procainamide Hydrochloride Impurity

Parent: Procainamide

CAS No.: 614-39-1

Cat No.: VL116001

Procainamide Hydrochloride Impurity 1

Parent: Procainamide

CAS No.: 49667-85-8

Cat No.: VE0022266

Procainamide N-oxide

Parent: Procainamide

CAS No.: 1025964-95-7

Cat No.: VE0023944

Procainamide N-Oxide (2HCl Salt)

Parent: Procainamide

CAS No.: 2724510-82-9

Cat No.: VE0022261

Procainamide Reference Standard

Parent: Procainamide

CAS No.: 51-06-9

Cat No.: VE0028032

Procainamide Related Compound

Impurities in procainamide may arise during chemical synthesis, formulation, or storage, and must be monitored in compliance with ICH Q3A/B and pharmacopeial standards.

Types of Impurities in Procainamide

Process-Related Impurities

Unreacted intermediates like p-aminobenzoic acid derivatives
Side products from amide bond formation or acetylation
Residual solvents such as methanol, acetone, or ethyl acetate

Degradation Impurities

N-acetylprocainamide (NAPA) – an active metabolite and degradation product
Oxidation products under light or heat
Hydrolysis products in aqueous or acidic conditions

Elemental Impurities

Trace levels of copper, iron, or lead from manufacturing equipment

Analytical Techniques for Impurity Detection

High-Performance Liquid Chromatography (HPLC)
Gas Chromatography (GC) for residual solvents
Liquid Chromatography–Mass Spectrometry (LC-MS)
Nuclear Magnetic Resonance (NMR) Spectroscopy
ICP-MS for elemental impurity analysis

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