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Recent research on nitrosamines, particularly nitrosamine drug substance related impurities (NDSRIs), highlights the complexity and widespread nature of these contaminants in pharmaceuticals. A collaboration among USP, LHASA Limited, AstraZeneca, Sai Life Sciences, and Merck revealed that a significant percentage of active pharmaceutical ingredients (APIs) and their impurities could be potential nitrosamine precursors. Improved analytical methods are being developed to enhance detection and risk assessment,

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kawthar.raafat11

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EN