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Ellutia releases fully automated total nitrosamine testing system

Ellutia is releasing its newest addition to its nitrosamine detection solutions, the Automated Total Nitrosamine Analyser (ATNA). The fully automated solution allows for rapid testing of apparent total nitrosamine content (ATNC) and has the right selectivity and sensitivity, so it can quickly identify whether or not nitrosamines are present down to 1ppb levels.

The ATNA provides fast, precise, and reliable results without requiring testing to be outsourced at different stages of the manufacturing process. It is comprised of Ellutia’s 800 series Thermal Energy Analyser (TEA), the industry standard for nitrosamine detection, interfaced to an autosampler configured to perform the chemical reactions and a bespoke inlet to introduce the sample to the TEA detector. With the European Medicines Agency (EMA) risk assessment now requiring pharmaceutical manufacturers to be able to classify nitrosamine content, nitrosamine detection has become a top priority for the entire industry producing human medicines. Nitrosamine impurities are becoming more and more of a health concern because they can cause cancer if people are exposed to them above safe levels and for an extended period of time.

Ellutia nitrosamine scaled

Current recognised methods for nitrosamine testing in pharmaceuticals, food and plastics include gas chromatography-mass spectrometry (GC-MS) or liquid chromatography (LC)-MS. These analytical techniques, however, can struggle with the required limits of detection and potentially produce false positive results. When new materials or solvents are added to a complex or multi-step reaction, there is a risk that harmful carcinogens could form at each stage of the process. Ellutia’s new ATNA is an alternative to GC and LC-MS instruments that can be used to easily screen samples for nitrosamine content before a more detailed speciated analysis is performed if required.

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