(S)-2-Aminobutanamide Monohydrochloride; USP Levetiracetam Related Compound B; Levetiracetam USP Related Compound B
Descripción
Levetiracetam Related Compound B (CAS 7682-4-20) | conocido como (S)-2-aminobutanamida monohidrocloruro | es una impureza relacionada que puede formarse durante la síntesis de levetiracetam; su presencia impacta la calidad y seguridad del fármaco. Su control analítico es crítico para garantizar la pureza del principio activo. Se caracteriza mediante HPLC y LC-MS para cuantificación y confirmación estructural | y por RMN para verificar configuración estereoquímica. Se recomienda establecer límites de especificación basados en criterios regulatorios y estudios toxicológicos | aplicar métodos de muestreo y validación robustos | e integrar optimización de procesos y monitoreo continuo en control de calidad.
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