Thermo Fisher Scientific has developed a reproducible and accurate ion chromatography (IC) method for determining monochloroacetic acid (MCAA) in carbocisteine drug substance and two carbocisteine drug products, thus enabling efficient quality control of the carbocisteine manufacturing process.
Application Note 1076: Determination of Monochloroacetic Acid in Carbocisteine demonstrates that this IC method is easily executed using a reagent-free IC system controlled by data management software.
The analyst simply adds water and samples to separate and accurately determine MCAA using a hydroxide-selective anion-exchange column (Thermo Scientific™ Dionex™ IonPac™ AS11-HC column).
Carbocisteine is a mucolytic drug frequently prescribed to improve the breathing of patients with chronic bronchitis and bronchial asthma. During the carbocisteine production process, the substrate MCAA-which is cardio- and hematotoxic-is used and is inevitably present in the carbocisteine drug substance and hence products.
Therefore, the determination of MCAA is important for the quality control of carbocisteine production. This new approach is sensitive and easier to use than other commonly used methods available to date.