Impureza 2 | 3-Dihydroxy-4-oxo-4-(6 | 7 | 9 | 10-tetrahydro-8H-6 | 10-methanoazepino[4 | 5-g]quinoxalin-8-yl)butanoic acid (CAS 2306217-15-0) | conocida también como Varenicline Tartrate Tetramide Impurity | Varenicline Tartaramide Formic Acid Salt y Varenicline Impurity 18 | es un degradado estructural que impacta el perfil de impurezas del API; su monitorización es crítica para control de calidad. Presenta grupos dihidroxilo y cetona que alteran polaridad y solubilidad | afectando estabilidad y comportamiento en síntesis. Requiere identificación y cuantificación por HPLC | LC-MS y RMN conforme a guías ICH | con estudios de degradación y límites específicos para garantizar seguridad | trazabilidad y cumplimiento regulatorio.
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