Naphazoline EP Impurity B, CAS 86-87-3, corresponde a uma impureza aromática oxigenada neutra com fórmula C12H10O2 e massa molecular 186.21. Estruturalmente, é compatível com um degradante de caráter benzílico ou de éter arílico, ou com um subproduto de processo, em vez de uma espécie mutagênica reativa. No contexto farmacopeico, é controlada como parte do perfil de substâncias relacionadas de preparações de nafazolina. A determinação geralmente exige separação cromatográfica ortogonal por HPLC em fase reversa, com confirmação por LC-MS ou GC-MS e, quando necessário, comparação por RMN com material de referência para distinguir aromáticos oxigenados isoméricos.
Referências
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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