Información adicional sobre el N-methyl-N-nitrosopropane-1 | 3-diamine
Fármaco de origen
Nitroso inhouse impurity
Nombre IUPAC
N-methyl-N-nitrosopropane-1,3-diamine
Sinónimos
N/A
SMILES
NCCCN(C)N=O
InChI
InChI=1S/C4H11N3O/c1-7(6-8)4-2-3-5/h2-5H2,1H3
Descripción
N-methyl-N-nitrosopropane-1,3-diamina es una impureza de tipo nitrosamina con fórmula molecular C4H11N3O y peso molecular de 117,09 g/mol. Estructuralmente incorpora un grupo N-nitroso sobre un andamiaje amino, motivo asociado con activación metabólica a especies electrofílicas y, por ello, con preocupación genotóxica conforme a ICH M7. Estos compuestos pueden formarse en condiciones nitrosantes durante la síntesis, el procesamiento o el almacenamiento cuando precursores amínicos entran en contacto con nitrito. Su cuantificación a nivel traza suele requerir GC-MS o LC-MS/MS, con monitoreo selectivo de iones e internos isotópicamente marcados.
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