Nitrosamine Impurities


One of the many services that we offer is determining nitrosamine impurities.

As we strive to keep pace with the industry, we have also focused on nitrosamines, which became a factor for endangering human lives if they exceed the maximum allowed levels approved by the FDA.

We have developed an in-house method to determine extremely low levels of nitrosamines using the required LC MSMS and GC MSMS equipment to ensure that your drugs meet all the requirements and are safe for users.

As we know this is a big problem in the industry, we are also focused on research into where in the production line of drug development these impurities occur and are open for collaboration.

Our services include LC and GC, as well as physicochemical analytics, so we cover the entire specification analytics for most drug products and raw materials, from colour and pH to assay, related substances and residual solvents. We can also offer full support for non-EU companies to launch their products here in the EU.

Nitrosamine analytics are the latest addition to our portfolio. We are using UPLC paired with a triple quadrupole mass detector. Our method uses a HILIC chromatographic column for determining the small, polar nitrosamines listed below. Usually, we are able to detect them in the 0.1–1.0ppb concentration range, depending on the sample provided.

Nitrosodimethylamine (NDMA)
Nitrosodiethylamine (NDEA)
Nitrosodibutylamine (NDBA)
Nitrosodiisopropylamine (NDIPA)
Nitrosoethylisopropylamine (NEIPA)
N-Nitrosomethylaminobutyric Acid (NMBA)

As well as the nitrosamines listed above, we also offer fast method development/optimization for other known nitrosamines.

We are here to help you.

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