Chromatography


The truth about Nitrosamine testing: Separating real risks from false alarms


Nitrosamines have become a critical concern across industries, from pharmaceuticals to cosmetics, due to their potential carcinogenic risks. Regulatory agencies, including the FDA and EMA, have introduced strict limits on nitrosamine contamination, requiring manufacturers to adopt advanced detection methods. However, many laboratories struggle with inflated nitrosamine results, often caused by nitrites, which interfere with accurate readings and create compliance challenges.


Nitrites, commonly found as residuals in raw materials and excipients, can react with amines under acidic conditions or high temperatures, forming new nitrosamines over time. This means that even if nitrosamine levels appear low initially, they could increase under certain storage conditions. Traditional detection methods often fail to distinguish between nitrites and nitrosamines, leading to overestimated contamination levels, unnecessary compliance concerns, and time-consuming retesting that delays production. To meet evolving regulatory expectations and minimise unnecessary disruptions, manufacturers need a more precise approach—one that separates nitrites from nitrosamines for true contamination insights.


The Automated Total Nitrosamine Analyser (ATNA) has been a trusted tool for labs conducting Total Nitrosamine Content (ATNC) analysis. Now, thanks to a significant advancement in vial chemistry, the ATNA can separate nitrites from nitrosamines, providing a clearer, more reliable contamination assessment. This breakthrough allows laboratories to eliminate nitrite interference, ensuring accurate nitrosamine detection, improving compliance, and reducing unnecessary re-testing. The ATNA’s ability to process up to 120 samples per run makes it ideal for high-throughput environments.


The system’s proprietary vial chemistry isolates and removes nitrites before measuring nitrosamine content separately. By comparing the total and nitrite-free results, labs can quantify the exact nitrite content. This process not only ensures compliance but also helps predict nitrosamine risks under storage and packaging conditions, allowing manufacturers to take proactive measures to prevent contamination.


Accurate nitrite detection isn’t just about meeting regulations - it helps prevent contamination at its source. By identifying excipients with high nitrite levels, manufacturers can choose safer raw materials, prevent costly recalls and reformulations, and improve overall product safety. With this enhanced level of accuracy, the ATNA empowers industries to manage nitrosamine risks confidently and efficiently.


To explore the critical role of nitrite separation and how the ATNA transforms nitrosamine analysis, watch our on-demand webinar at your convenience. Learn how this innovation can improve compliance, reduce unnecessary testing, and deliver more precise nitrosamine detection.


More information online: ilmt.co/PL/BNpK 64036pr@reply-direct.com


Missed our webinar? Watch the recording: Detecting unexpected nitrosamine contamination


Nitrosamines remain a critical concern across multiple industries, from pharmaceuticals to cosmetics, due to their potential carcinogenic risks. Regulatory bodies such as the FDA and EMA have established stringent thresholds, compelling manufacturers to implement advanced monitoring and detection strategies to ensure compliance.


One of the greatest challenges in nitrosamine analysis is detecting a nitrosamine that


was not anticipated in a sample. While targeted testing via GC or LC can identify known nitrosamines - provided reference standards are available - unexpected nitrosamine contamination may go undetected.


Ellutia’s recent webinar explored innovative analytical approaches that enable the identification of potential nitrosamine contaminants without requiring specific reference standards.


Key topics covered in the webinar include:


• How a non-targeted screening approach to nitrosamine analysis can help flag potential contamination


• The operation of the Automated Total Nitrosamine Analyser (ATNA) and its ability to rapidly perform Apparent Total Nitrosamine Content (ATNC) analysis down to low ppb levels


• Strategies to avoid false positives during ATNC analysis caused by compounds such as nitrites


• How GC-TEA can be used to further analyse potential unexpected nitrosamine contamination


• Real-world case studies where this technology successfully identified unexpected nitrosamines


The webinar also featured a live Q&A session with Ellutia’s Senior Application Chemist, Mr Jonathan Angove, addressing audience questions in real time.


Watch the webinar recording now. If you missed the live session, you can watch the full recording here: ilmt.co/PL/KmBe


For further details about the ATNA and how it can enhance your nitrosamine analysis, visit Ellutia’s website. More information online: ilmt.co/PL/n39m


64037pr@reply-direct.com


Supporting UK and Ireland labs with certifi ed ECD solutions


At Ellutia, we understand that managing Electron Capture Detectors (ECDs) is a complex and critical responsibility for laboratories. These detectors play a crucial role in industries like environmental monitoring, pharmaceuticals, and food safety due to their ability to detect trace amounts of specific compounds. However, their radioactive nature means that maintaining and


disposing of them correctly is essential. As one of the few UK government-certified sites authorised to perform ECD services, we’re uniquely equipped to help labs across the UK and Ireland navigate these challenges with confidence and compliance.


It is illegal to remove an ECD from an instrument and store it without the proper license. Simply placing an ECD in a cupboard or drawer without the necessary authorisation puts your lab at risk of non-compliance, regulatory fines, and potential safety hazards. If your lab has an unused or End-of-Life ECD, it must be disposed of properly through a government- certified provider.


Disposing of ECDs can be a daunting process, given the strict regulations surrounding radioactive materials. Our comprehensive disposal service ensures that your ECDs are handled safely and legally, from initial verification to final documentation. By partnering with Ellutia, you can be confident that your lab is not only compliant but also contributing to responsible environmental practices. For more information about our hassle-free ECD disposal process, visit our disposal page.


Regular maintenance, including wipe testing, is equally important to keep your ECDs operating safely and effectively. Over time, detectors can accumulate contamination from samples, which may affect their performance and pose safety risks. In the UK, it is a legal requirement for ECDs to be tested every 18 months. If your detector hasn’t been tested within this period, you risk being non-compliant. Our easy-to-use wipe test kits allow you to check for contamination in-house, without needing external consultants. Simply collect the samples and send them to us for analysis. We’ll provide a detailed report, ensuring your lab meets all safety and compliance standards. To learn more about our ECD wipe testing service, visit our wipe test page.


If you’re looking for a trusted partner to manage your ECDs, we’re here to help. Whether you need disposal, maintenance, or compliance support, Ellutia offers reliable and professional solutions tailored to your lab’s needs. Reach out to us today to learn more about how we can support your laboratory and keep your operations running smoothly and safely.


More information online: ilmt.co/PL/2ypy and ilmt.co/PL/3yp1 64038pr@reply-direct.com


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