La Impureza 38 de rivaroxabán, CAS 1082588-73-5, corresponde a una impureza heteroaromática de baja masa molecular con fórmula molecular C10H12N2O2 y peso molecular de 192.21 g/mol. Su composición indica un andamiaje pequeño y polar que puede generarse durante la secuencia sintética, por escisión de cadenas laterales o por transformación oxidativa de intermedios relacionados con rivaroxabán, más que como nitrosamina o derivado nitroso clásico. En la evaluación regulatoria se consideran alertas estructurales, posible potencial mutagénico y relevancia en el balance de masa. La caracterización a nivel de trazas suele requerir LC-MS/MS con confirmación por MS de alta resolución, y métodos ortogonales de LC-UV o GC-MS cuando la volatilidad y la derivatización lo permiten.
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