El clorhidrato del éster metílico de D-alanina (CAS 14316-06-4) es una impureza crítica en procesos de síntesis peptídica y farmacéutica | originada por esterificación incompleta o transesterificación y posible racemización. Su presencia influye en el perfil de impurezas | pureza enantiomérica y rendimiento del producto final. Su detección y cuantificación se realiza mediante HPLC | GC-MS | NMR y análisis de quiralidad | permitiendo establecer límites de aceptación y criterios de liberación. El control se basa en métodos analíticos validados | purificación por cromatografía y optimización de condiciones de reacción. Su estabilidad y comportamiento higroscópico deben evaluarse para garantizar cumplimiento regulatorio y reproducibilidad del proceso.
Referencias
“Synthesis of D-Alanine Oligopeptides Catalyzed by D-Aminopeptidase in Non-Aqueous Media.â€Â Biocatalysis, 2021,  www.tandfonline.com/doi/abs/10.3109/10242429008992063.
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