Naphazoline EP Impurity B, CAS 86-87-3, corresponde a una impureza aromática oxigenada y neutra con fórmula C12H10O2 y peso molecular 186.21. Desde el punto de vista estructural, es compatible con un degradante de tipo bencílico o éter arílico, o con un subproducto de proceso, más que con una especie mutagénica reactiva. En el contexto farmacopeico se controla como parte del perfil de sustancias relacionadas de las preparaciones de nafazolina. Su determinación suele requerir separación cromatográfica ortogonal mediante HPLC en fase reversa, con confirmación por LC-MS o GC-MS y, cuando procede, comparación por RMN con un material de referencia para discriminar aromáticos oxigenados isoméricos.
Referencias
Rajan, S. S. “1-Naphthaleneacetic Acid.†Acta Crystallographica Section B Structural Crystallography and Crystal Chemistry, vol. 34, no. 3, Mar. 1978, pp. 998–1000, https://doi.org/10.1107/s0567740878004641 HURWITZ, P., and J. M. THOMPSON. “USES of NAPHAZOLINE (PRIVINE(R)) in OPHTHALMOLOGY.†Archives of Ophthalmology, vol. 43, no. 4, Apr. 1950, pp. 712–17, https://doi.org/10.1001/archopht.1950.00910010723008.
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