Dimethylamine Determination in Metformin HCI Drug Products

Thermo Fisher Scientific Inc. has developed a more sensitive method for detection of process-related impurity dimethylamine, a suspected human carcinogen, in metformin hydrochloride (HCI).

The method in Application Note 298: Determination of Dimethylamine in Metformin HCl Drug Product Using IC with Suppressed Conductivity Detection uses a Thermo Scientific Dionex IonPac CS19 cation-exchange analytical column with methanesulfonic acid eluent produced by the Dionex ICS ion chromatography (IC) system’s eluent generator.

Metformin HCI is the most widely prescribed orally administered drug for the treatment of type 2 diabetes and is also used for treatment of polycystic ovary syndrome.

To confirm the consistency of the manufacturing process, drug product manufacturers must monitor the level of impurities before commercial release of a drug product.