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Understanding Nitroso Impurity Standards in Pharmaceuticals

In the pharmaceutical industry, impurity profiling plays a crucial role in ensuring drug safety and efficacy. One particular category of concern is nitroso impurities, which have gained significant attention due to their potential carcinogenic properties. Regulatory bodies such as the U.S. FDA, EMA, and ICH have issued stringent guidelines for controlling these impurities in active pharmaceutical ingredients (APIs) and finished drug products.<br><br>This blog provides an in-depth look into nitroso impurities, their formation, regulatory concerns, detection methods, and their importance in pharmaceut

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Understanding Nitroso Impurity Standards in Pharmaceuticals

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