(2RS)-2-methyl-2, 3-dihydro-1H-indol-1-amine mesylate salt
Sinónimos
N/A
Descripción
Indapamida EP Impurity C (Mesylate Salt) | CAS 85392-00-3 | es una impureza relevante en el control de calidad de materias primas y formulaciones de indapamida. Esta impureza mesilato requiere identificación y cuantificación precisas mediante técnicas cromatográficas y espectrométricas como HPLC | LC-MS y NMR para evaluar su perfil químico y masa molecular. Puede originarse durante etapas sintéticas o en estudios de degradación y afectar la pureza y estabilidad del lote si no se controla. Su caracterización detallada y los límites analíticos deben establecerse conforme a la Farmacopea Europea e ICH Q3A/Q3B | integrando métodos validados para asegurar cumplimiento regulatorio.
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