Thermo Fisher Scientific has developed an accurate and reproducible method that uses an innovative ion chromatography system for the determination of methylamine (or monomethylamine, MMA) in drug products. Application Note (AN) 1057: Determination of Methylamine in Drug Products demonstrates simple off-line sample preparation followed by an on-line step to complete the sample preparation before analysis. This approach requires only 32 min per analysis. The method uses a cation-exchange column and the eluent is produced by an eluent generator to preclude the labor and potential error associated with eluent preparation.
As MMA is widely used in different stages of drug substance preparation, it can be retained in those substances and hence it is important to have an easy and accurate MMA assay method. For any drug substance, the manufacturer must monitor the level of anticipated process-related and degradation impurities before commercial release to ensure product safety and consistency of the manufacturing process. Any MMA in the drug substance will be retained in the drug product and AN 1057 demonstrates that MMA can be determined in two drug products.