• Transforming Nitrite Screening in Pharma

Chromatography

Transforming Nitrite Screening in Pharma

Aug 13 2023

Pharmaceutical manufacturers face the demanding and complex task of controlling nitrosamine levels within their product lines. One of the most effective ways of managing this is to control the levels of nitrites within the product. However, a quick and effective method for establishing the level of nitrite content present down to very low ppb levels has proved challenging with existing technology and methods.

The Automated Total Nitrosamine Analyser (ATNA) from Ellutia, can help pharmaceutical companies tackle this challenge. Whilst most commonly used for nitrosamine screening, The ATNA can also rapidly screen for total nitrite content down to low ppb levels.

The System can handle a wide range of sample types with minimal sample preparation. Samples are placed into headspace vials along with a reagent mixture. The Robotic Autosampler then performs the chemical reaction, and the headspace is sampled and directly injected into the Ellutia TEA Detector. This means there is no separation of compounds, and a single result for total content is produced. Specifically developed SPE cartridges can be used to differentiate between signals from nitrosamine and nitrite compounds.

The ATNA allows users to rapidly screen samples for both nitrosamine and nitrite content, giving greater confidence and visibility of where potential issues may be. Allowing them to focus resources where it really matters.

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