Gas chromatography
Most nitrosamine testing starts with a list. You define the compounds you are looking for, build your method around them, and confirm what your samples contain. It’s a good approach. Until a nitrosamine appears that was not on the list.
This is not a hypothetical risk. After NDMA was found in valsartan in 2018, regulators asked manufacturers across the sartan class to look more broadly at their products. What followed were recalls of losartan, irbesartan, and others. Nitrosamines appearing in products from different manufacturers, different processes, that had all passed standard quality checks. Nobody had screened for them because nobody had thought to include them on the target list.
The question these incidents raised, and that regulators and QC teams are still working through, is if targeted detection alone is sufficient. The answer, increasingly, is no.
The Thermal Energy Analyser, which interfaces with most major GC’s, works differently from mass spectrometry. Rather than identifying compounds by molecular mass, it responds to the nitrogen-oxide bond present in every nitrosamine compound without exception. It does not need a target list. For total screening, a single generic nitrosamine standard is enough. For targeted work, the TEA still requires calibration for known compounds. Any unexpected nitrosamine will still produce a distinct peak, even without a reference standard to match it. This means the TEA will flag a nitrosamine it has never been calibrated for. In complex matrices like pharmaceutical APIs, cosmetic formulations, and food ingredients, the results are clean and reliable, with no interference from the surrounding matrix.
The TEA gives a fast, low-cost screen. If nitrosamine activity falls within acceptable limits, the sample moves on. If the TEA flags something of concern, that is when targeted MS analysis takes over. That workflow is faster and cheaper than running everything through MS. It also gives you something a target list alone cannot: a defensible record that you looked beyond what you already knew to find. And any nitrosamine that was not on that list will still show up.
Nitrosamine testing requirements now span pharmaceuticals, cosmetics and personal care, food production, rubber and packaging, and environmental monitoring. In every case, the challenge is the same. Detect nitrosamines reliably, at low concentrations, in complex matrices, with methods regulators will accept.
Nitrosamine testing is no longer a question of which compounds to screen for. It is a question of what you might be missing. Ellutia's nitrosamine analysis systems are built around the 800 Series Thermal Energy Analyser: the detector that responds to every nitrosamine, not just the ones on your list.
Watch: Why a Nitrosamine-Specific Detector Changes Everything
Product directory
