La impureza (2R | 4S)-4-amino-2-methyl-5-(4-phenylphenyl)pentanoic acid (CAS 1039307-95-3) es un subproducto estereoquímico caracterizado por centros quirales que pueden generar enantiómeros y diastereómeros; su presencia compromete la pureza óptica y puede interferir en etapas sintéticas posteriores | por lo que requiere perfilado de impurezas mediante HPLC quiral | LC-MS y RMN 1H/13C para cuantificación y elucidación estructural. Esta impureza suele formarse por inversión estereoquímica o reacciones secundarias y se controla mediante especificaciones analíticas | límites de aceptación basados en evaluación de riesgo y estrategias de purificación como cristalización o cromatografía; la documentación trazable y métodos validados son esenciales para su mitigación.
Referencias
Fala, L. (2015). Entresto (Sacubitril/Valsartan): First-in-Class Angiotensin Receptor Neprilysin Inhibitor FDA Approved for Patients with Heart Failure. American Health & Drug Benefits, 8(6), 330–334. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4636283/
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