Discovery of mutagenic N-nitrosamine impurities in pharmaceutical products in 2018 resulted in widescale product recalls and prompted global action by regulators. Nitrosamine contamination and formation pathways are diverse – especially for the more common volatile nitrosamine impurities, such as N­-nitrosodimethylamine (NDMA).

Methods utilizing gas and liquid chromatography (GC and LC) methods are conventionally used for analysis of volatile nitrosamines, but these require significant sample preparation and have a run-time of approximately 15 minutes. When including calibration sets, this can mean significant delays in getting critical early data. Furthermore, they are impractical for wider scale product screening.

In contrast, adoption of selected ion flow tube mass spectrometry (SIFT-MS) greatly simplifies sample preparation (drug product is simply weighed into the vial) and eliminates the slow chromatography step. SIFT-MS both speeds up sample analysis and significantly reduces sample prep because no derivatization of the highly polar nitrosamines is required.

Assuming the best-case scenario for the traditional methods (that is, automated sample prep), SIFT-MS is twice as fast to the first result all other things being equal. If manual sample prep is used, then SIFT-MS is four times faster. Even better, SIFT-MS does not require recalibration every day – so you can have results in just 35 minutes, or up to 8x faster!

Download the new Syft application notes on NDMA analysis to learn more.

Simple, Rapid Analysis Of N-Nitrosodimethylamine (NDMA) Impurity In Ranitidine Products Using SIFT-MS

Simple Rapid Analysis of NDMA in a Recalled Valsartan Product Using SIFT-MS