Total Nitrosamine Testing for Pharmaceuticals Introduced

As the European Medicines Agency (EMA) risk assessment deadline takes hold, Ellutia’s total nitrosamines pre-screening solution offers the pharmaceutical industry a simple, accurate and reliable test. This delivers a clear pass/fail result for apparent total nitrosamine content (ATNC) in minutes, allowing samples to be immediately cleared for processing or sent for further testing.

From April 2020, all marketing authorisation holders of medicines containing chemically synthesised active pharmaceutical ingredients (APIs) must conduct a risk assessment to evaluate the possibility of nitrosamines being present.

Any sample showing an ATNC below the World Health Organisation (WHO)’s specified interim limit cannot possibly contain any one nitrosamine above the total level, and so can be deemed safe.

The Ellutia ATNC test is based on the 800 Series Thermal Energy Analyser (TEA) interfaced to a unique chemical stripping system. It allows pharmaceutical manufacturers to meet the requirements of the EMA risk assessment without needing to outsource testing of raw materials or of product at different stages of manufacturing.

Andrew James, Marketing Director at Ellutia, said: “Measuring apparent total nitrosamine content (ATNC) provides a benchmark of the nitrosamine volume in a product. Rather than embark on a lengthy analytical process to deliver detailed and speciated results in the first instance, the ATNC method screens only for the total nitrosamine content, both volatile and non-volatile compounds, and returns an analysis with a single clear peak. If this peak falls under the interim allowable daily intakes set by the World Health Organisation (WHO) for specific species of nitrosamines, the total nitrosamine content is permitted and the product is safe.

“In contrast, any sample found to contain an ATNC outside the safe level can be red flagged and sent for further analysis by a TEA interfaced to a GC or HPLC to individually identify the species and quantify the presence of nitrosamines such as NDMA.

“The risk assessment requirement from the European medicines agency means that pharmaceutical manufacturers need to take a serious look at potential nitrosamine contamination in their product lines. In America, too, the US Food and Drug Administration (FDA) has also already acted to call in various drugs known as ARBs for testing.”

The TEA has become the industry go-to for nitrosamine testing in GMP manufacturing environments such as food safety and materials testing. Coupled with Ellutia’s chemical stripping system, the instrument is seeing take up in pharmaceuticals testing.

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