N-Nitroso 5,6-Dihydro Tofacitinib es una impureza relacionada con nitrosaminas, originada por N-nitrosación del nitrógeno piperidínico en el esqueleto de 5,6-dihidro tofacitinib. Con fórmula molecular C16H21N7O2 y peso molecular de 343.38 g/mol, su estructura es compatible con un contaminante de proceso o degradación presente a nivel traza y con posible potencial genotóxico. Las nitrosaminas se gestionan bajo ICH M7 y marcos regulatorios afines por su preocupación carcinogénica. Su detección suele requerir LC-MS/MS de alta selectividad, complementada con espectrometría de masas de alta resolución y confirmación cromatográfica ortogonal, ya que los métodos UV no son adecuados para cuantificación traza.
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To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.
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The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
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