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
At Lab Innovations 2022, Ellutia will present the 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 composed 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.
They can be present in active pharmaceutical ingredients (APIs), depending on the ingredients and solvents used in the manufacturing process; therefore, it is imperative for manufacturers to be able to test for nitrosamines at different points along the production line.
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.
The new automated system will be on show at stand A52 at this year’s Lab Innovations, alongside three other Ellutia instruments; the 800 Series TEA, 500 Series Ultra-Fast GC, and 200 Series compact GC. The four products showcase what Ellutia does best – solving analytical challenges and sample handling with innovative and unique chromatography instruments and detectors.
Andrew James, Marketing Director at Ellutia, said: “The ATNA is the next step in nitrosamine detection and brings many additional benefits to those in the food, pharmaceutical and material industries. Lab Innovations will be a great opportunity to witness the rapid nitrosamine detection capabilities offered by the ATNA. It will be the first time we’re showcasing our newest solution in the UK, and we are thrilled that it has been shortlisted for the event’s Lab Automation Award. Many of our customers already use our 800 Series TEA or the manual chemical stripping system, so they are keen to further extend their manufacturing capabilities. Users can easily upgrade their existing instruments to the new fully automated system.”