La impureza (R)-N-((R)-1-Amino-1-oxobutan-2-yl)-3-((((S)-1-amino-1-oxobutan-2-yl)amino)methyl)hexanamide se caracteriza por una estructura diamida quiral con múltiples centros estereogénicos que incrementan su polaridad y complejidad analítica; suele generarse por epimerización parcial | acoplamientos incompletos o transamidación durante la síntesis peptídica y puede afectar el perfil de pureza | la estabilidad y la seguridad del producto final. Su detección y cuantificación requiere métodos validados como HPLC y HPLC quiral complementados con LC-MS y RMN para confirmar la identidad y la relación enantiómica. El control se logra mediante optimización de condiciones de acoplamiento | control de temperatura | extracción selectiva y purificación por HPLC preparativa | con criterios de aceptación específicos en el control de calidad.
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