• Advancing pharmaceutical quality: ATNC control with Ellutia's ATNA

Chromatography

Advancing pharmaceutical quality: ATNC control with Ellutia's ATNA

Jan 05 2024

In the pharmaceutical world, the control of Apparent Total Nitrosamine Content (ATNC) is crucial. The consequences of not managing these compounds extend beyond costs, involving damage to reputation and potential health risks, including the spectre of cancer in consumers.

Effectively tackling this challenge involves a proactive approach, emphasising ATNC control at its source. Swift and effective methods for confirming samples are free of nitrosamine content down to low ppb levels, have proven elusive with existing technology and methods.

Ellutia’s Automated Total Nitrosamine Analyser (ATNA) is a beacon for pharmaceutical manufacturers navigating the complex landscape of ATNC control. The ATNA, primarily acknowledged for its prowess in nitrosamine screening, extends its capabilities to encompass rapid screening for ATNC levels down to low ppb. This system accommodates a range of sample types with minimal preparation, streamlining the analysis process.

Operational simplicity meets efficiency in the ATNA's functionality. Samples undergo a seamless process - placed in vials with a reagent mixture, subjected to a chemical reaction by the Robotic Autosampler, and then injected into the Ellutia TEA Detector. This detector, highly sensitive and selective, detects at low ppb levels, enabling the analysis of up to 10 samples per hour.

The absence of compound separation yields a single result for total ATNC content, providing a definitive understanding for further investigation. The ATNA ensures a targeted approach, allowing pharmaceutical manufacturers to focus resources where they genuinely matter, steering clear of unnecessary investment in blank samples.

If you're dedicated to improving pharmaceutical quality with accurate ATNC control, the ATNA provides a valuable advantage. Discover its capabilities.


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