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A process to synthesize salbutamol nitrosamine impurities under mild conditions, ensuring quality control standards.
To ensure strict quality control standards, improve yields, and meet regulatory requirements, the synthesis of N ‐nitroso impurities of salbutamol is essential. These studies help in understanding, monitoring, and mitigating the risks associated with the presence of potentially harmful nitrosamine impurities in pharmaceuticals. Therefore, the preparation of N ‐nitroso salbutamol impurity is necessary to verify and challenge previous analytical findings. This process outlines the synthesis of N ‐nitroso salbutamol impurities A, D, and F from the corresponding raw materials in a few simple steps, under mild reaction conditions, while achieving good yields.
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Prasad et al. (2025) studied this question.
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