Trace-level aliphatic amines in cationic pharmaceutical ingredients

Application Note AN-S-401 Nitrite in duloxetine hydrochloride API Ion chromatography method with automated sample preconcentration, matrix elimination, and UV/VIS detection Recently, the FDA released a guidance document for Dimethylamine is used during the synthesis of many pharmaceutical manufacturers regarding the…

Thunyarat Phesatcha,1 Suparerk Tukkeeree,1 and Jeff Rohrer2 Thermo Fisher Scientific, Bangkok, Thailand; 2Thermo Fisher Scientific, Sunnyvale, CA, USA 1 Key Words Pharmaceutical, Dionex IonPac CS19 Column, Reagent-Free Ion Chromatography Introduction Methylamine or monomethylamine (MMA) is widely used in different stages…

Application Note AN-S-402 Nitrite in hydroxypropyl methylcellulose Ion chromatography method with automated sample preconcentration, matrix elimination, and UV/VIS detection The FDA has recently issued some guidance for medications. Under acidic conditions, it reacts with managing nitrosamine impurities in pharmaceutical nitrite,…

Metrohm White paper IC: The all-rounder in pharmaceutical analysis Stephanie Kappes, Alfred Steinbach, and Katinka Ruth Ion chromatography is a flexible technique with a wide variety of practical uses in the pharma sector – here we take a look at…