Analysis of selected drug formulations for volatile nitrosamines

A number of selected drug formulations on the Canadian market were analyzed for N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) content by using a gas chromatograph interfaced to a thermal energy analyzer (GC/TEA). Of the 34 formulations analyzed, NDMA was found in 21 at levels up to 12 ppb and NDEA was found in 11 at levels up to 0.6 ppb. In many cases, the drug entity in the formulation did not contain the precursors for the observed nitrosamines.