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Ion Chromatography Easily Determines Methylamine in Drug Products

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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 aneluent 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. 

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $12 billion, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity™ Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity.


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