Enalapril Impurity 4 (CAS 147-85-3) | conocida también como (2S)-pyrrolidine-2-carboxylic acid | 2-pyrrolidinecarboxylic acid o L-prolina | es una impureza polar y zwitteriónica que puede formarse durante la síntesis o degradación del API. Su detección y cuantificación impactan el perfil de impurezas y requieren técnicas analíticas robustas como HPLC con detección adecuada | LC-MS y confirmación por RMN para asegurar trazabilidad y especificaciones. Con propiedades fisicoquímicas propias de un aminoácido | muestra alta solubilidad en agua y comportamiento estable en rangos de pH moderados | por lo que su control es esencial para el cumplimiento regulatorio y la garantía de calidad del lote.
Referencias
‘Davies, Richard O., et al. “Enalapril Worldwide Experience.†The American Journal of Medicine, vol. 77, no. 2, Aug. 1984, pp. 23–35, https://doi.org/10.1016/s0002-9343(84)80055-8. ?Todd, Peter A., and Karen L. Goa. “Enalapril.†Drugs, vol. 43, no. 3, Mar. 1992, pp. 346–81, https://doi.org/10.2165/00003495-199243030-00005. ?’
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![(2S)-1-[(2S)-2-[[(1S)-1-(butoxycarbonyl)-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid](https://veeprho.com/wp-content/uploads/2022/07/Enalapril-EP-Impurity-F-free-base-.png "(2S)-1-[(2S)-2-[[(1S)-1-(butoxycarbonyl)-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid")