Naphazoline EP Impurity B, CAS 86-87-3, bezeichnet eine neutrale aromatische sauerstoffhaltige Verunreinigung mit der Summenformel C12H10O2 und einer Molekülmasse von 186,21. Strukturell ist sie mit einem benzylichen beziehungsweise aryl-etherartigen Abbauprodukt oder prozessbedingten Nebenprodukt vereinbar und nicht mit einer reaktiven mutagenen Spezies. Im pharmakopöischen Kontext wird sie als Bestandteil des Profils verwandter Substanzen von Naphazolin-Präparaten überwacht. Für die Bestimmung sind in der Regel orthogonale chromatographische Trennungen mittels RP-HPLC erforderlich, ergänzt durch LC-MS oder GC-MS und, falls nötig, NMR-Vergleich mit einer Referenzsubstanz zur Differenzierung isomerer oxygenierter Aromaten.
References
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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