Trends and Challenges in Nitrosamine Testing: Part Five – Pharma’s Future
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May 1, 2026
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1
The discovery of nitrosamines in sartans led to a review of medicinal products, identifying many compounds at risk for nitrosamine formation.
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Future nitrosamine analysis will focus on prevention strategies, including the use of scavengers and inhibitors to control nitrosamine formation.
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Advancements in analytical techniques, such as high resolution mass spectrometry, are expected to enhance nitrosamine detection and analysis.
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Collaboration between regulatory agencies, industry, and researchers is crucial for understanding and controlling nitrosamine impurities.
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Heightened regulatory scrutiny has prompted the pharmaceutical industry to adopt sensitive analytical methods and robust risk assessments.