Impureza Alanyl Glutamine Impurity 21 (CAS 159141-33-0) | N2-[(2R)-2-cloro-1-oxopropil]-L-glutamina | es un subproducto clorado derivado de la acilación del residuo alanyl. Presenta una masa y polaridad alteradas respecto al principio activo | lo que facilita su identificación por LC-MS y confirmación estructural por RMN. Su presencia suele originarse por uso de cloranhidrinas o por reacciones secundarias durante la síntesis y puede afectar especificaciones de pureza. Requiere establecimiento de límites y métodos cuantitativos robustos HPLC-UV y LC-MS con validación según ICH Q3A para control de lote | estabilidad y estudios de degradación forzada.
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