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NDMA contamination in metformin: Detection, risks, and best practices


Ellutia, a global leader in nitrosamine analysis, has published a detailed blog post covering a range of topics around N-nitrosodimethylamine (NDMA) impurities in metformin. The article provides invaluable insights for pharmaceutical professionals navigating the challenges of detecting this harmful carcinogen in a medication relied upon by millions for managing type 2 diabetes.


The presence of NDMA in metformin has raised significant safety concerns within the pharmaceutical industry. Regulatory agencies worldwide have implemented stringent guidelines for its detection, emphasising the critical need for reliable testing methods. Ellutia’s latest blog examines the challenges of NDMA contamination, the regulations governing its detection, and the advanced techniques that help ensure compliance and safeguard patient health.


Key highlights of the blog post: • Understanding NDMA formation: An overview of how NDMA impurities arise in metformin


• Best Practises for controlling Formation: A discussion on the health implications of NDMA exposure and the importance of stringent quality control


• Detection Techniques: An Overview of the different techniques that can be used to test for NDMA in Metformin


“Ensuring the safety of pharmaceutical products is our highest priority,” said Andrew James, Managing Director at Ellutia. “This blog reflects the insights we’ve gained by working closely with customers to address NDMA contamination in metformin, and we’re proud to share this valuable resource with the industry.”


Ellutia’s work in nitrosamine analysis demonstrates its commitment to advancing pharmaceutical safety through innovative technologies and practical expertise. By following the best practices outlined in this blog, companies can take proactive steps to protect their products and strengthen trust with their customers.


Read the full blog post: ilmt.co/PL/plvw


Ellutia invites industry professionals, researchers, and regulators to explore this insightful resource and join the conversation on enhancing pharmaceutical safety. To learn about about Ellutia’s range of solutions for nitrosamine analysis in the pharmaceutical industry, visit the website.


More information online: ilmt.co/PL/x5G5 63845pr@reply-direct.com


Free webinar: Detecting unexpected nitrosamine contamination


Nitrosamines are a major concern across industries, from pharmaceuticals to cosmetics, due to their potential carcinogenic risks. Regulatory agencies, such as the FDA and EMA, have introduced stringent thresholds for nitrosamines, requiring manufacturers to adopt robust monitoring and detection methods to maintain compliance.


One of the most significant challenges of Nitrosamine analysis is how you detect a nitrosamine that you are not expecting to be present. While speciated, testing by GC or LC can offer a route to analyse expected nitrosamines (provided a reference standard is available), any unexpected nitrosamine content can potentially be missed.


On the 27th of February at 14:00 GMT Ellutia will be hosting a live webinar that will cover different analytical approaches that allow you to identify the presence of potential nitrosamine contaminants without needing specific standards.


In the webinar you will learn about; • How a non-targeted screening approach to nitrosamine analysis can help flag issues


• How the Automated Total Nitrosamine Analyser (ATNA) operates and can rapidly perform Apparent Total Nitrosamine Content (ATNC) analysis on samples to detect potential nitrosamine content down to low ppb levels


• How to avoid potential 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 examples where this technology had been used to flag an unexpected nitrosamine


Following the webinar there will be a live Q&A session where you will be able to put your questions directly to Ellutia’s Senior application chemist Mr Jonathan Angove. To sign up for this free webinar please visit ilmt.co/PL/O3d5 Learn more about the ATNA.


More information online: ilmt.co/PL/LxqA 63846pr@reply-direct.com


LABMATE UK & IRELAND - FEBRUARY 2025 - ADVERTORIAL


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