Mitigating Risks of N-Nitroso Impurities in Drug Manufacturing
N-Nitroso impurities, a class of potent mutagenic and carcinogenic compounds, have emerged as a significant concern in the pharmaceutical industry. These impurities can form during the manufacturing process of active pharmaceutical ingredients (APIs) and drug products, posing severe health risks to patients. As regulatory bodies tighten their guidelines and enforcement measures, pharmaceutical companies are under
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