Naphazoline EP Impurity C (CAS 132-75-2) es una impureza conocida en el perfil analítico del naphazoline que requiere vigilancia durante la síntesis y formulación. Presenta propiedades físico-químicas y espectrales que permiten su identificación mediante HPLC acoplada a espectrometría de masas y RMN para confirmación estructural. Su presencia puede influir en el ensayo y la estabilidad del principio activo | por lo que debe incluirse en las especificaciones de control de calidad con límites definidos y métodos validados. Se recomiendan estrategias de mitigación en procesos y estudios de degradación forzados para asegurar cumplimiento con requisitos regulatorios y trazabilidad en la documentación.
Referencias
LAHIRI, V. N. “Report on the Structure of Carbazole, C12H9N.†Zeitschrift Für Kristallographie – Crystalline Materials, vol. 127, no. 1-6, Dec. 1968, pp. 456–59, https://doi.org/10.1524/zkri.1968.127.16.456.?“Simultaneous Determination of Naphazoline Nitrate and Tetramethylthionine Base in Eye Drops by First-Derivative UV Spectrophotometry.†Taylor & Francis, 2021, www.tandfonline.com/doi/abs/10.1080/00032719908542826.?
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