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Nitrosamine Drug Substance Related Impurities (NDSRIs) are potential carcinogens that can form in drug products under certain conditions. Regulatory agencies like the FDA and EMA have set strict limits and testing guidelines to ensure drug safety. Manufacturers must assess and control NDSRI risks during drug development and production. <br><br>Know more here- https://www.ipa-india.org/wp-content/uploads/2025/02/Best_Practice_guidelines_on_Nitrosamines_and_NDSRIs_in_Pharma_Products.pdf
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