El estándar de trabajo de Levetiracetam (CAS 102767-28-2) incorpora una impureza relacionada estructuralmente que requiere caracterización precisa. Esta impureza presenta propiedades fisicoquímicas similares al compuesto principal | se detecta y cuantifica por HPLC con detectores UV y confirmación por LC-MS | y muestra señales características en RMN que permiten su identificación. Su perfil de retención y espectrometría facilitan la definición de límites de aceptación y evaluación de estabilidad frente a degradación y racemización. La documentación analítica describe pureza | espectros y comportamiento cromatográfico | proporcionando trazabilidad y soporte técnico para evaluación de perfil de impurezas.
Referencias
Sonawane, Sandeep S., et al. “Development and Validation of Stability-Indicating HPLC Method for the Quantification of Levetiracetam in Bulk and Oral Solution: Application to Chemical Kinetics.†Pharmaceutical Chemistry Journal, vol. 54, no. 8, Nov. 2020, pp. 870–76, https://doi.org/10.1007/s11094-020-02290-z. ?
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