Olmesartan Related Compound A; Olmesartan EP Impurity B; Olmesartan Gama-Lactone; Olmesartan Lactone; Olmesartan Lactone Impurity; 3, 6-Dihydro-6, 6-dimethyl-2-propyl-3-[[2′-(2H-tetrazol-5-yl)[1, 1′-biphenyl]-4-yl]methyl]-4H-Furo[3, 4-d]imidazol-4-one; Olmesartan EP Impurity B;
Descripción
Olmesartan EP Impurity B (CAS 849206-43-5) | conocida también como Olmesartan lactona u Olmesartan Related Compound A | es una impureza de lactona formada por ciclización intramolecular del principio activo. Su estructura | 3 | 6-dihidro-6 | 6-dimetil-2-propil-3-[[2′-(2H-tetrazol-5-yl)[1 | 1′-bifenil]-4-il]metil]-4H-furo[3 | 4-d]imidazol-4-ona | requiere monitorización estricta debido a su efecto sobre el perfil de pureza y estabilidad. La detección y cuantificación se realizan mediante HPLC con detección UV | confirmación por LC-MS y caracterización estructural por RMN e IR. Controles analíticos y de proceso robustos son esenciales para gestionar su presencia y garantizar cumplimiento regulatorio.
Referencias
Srinivasu, Kondra, et al. “Novel Analytical Method Using Acquity QDa Mass Detector Coupled with LC-PDA for Impurity Profiling of Amlodipine Besylate and Olmesartan Medoxomil in Fixed Dose Tablets Formulation.†Saudi Journal of Medical and Pharmaceutical Sciences, vol. 05, no. 10, Oct. 2019, pp. 871–84, https://doi.org/10.36348/sjmps.2019.v05i10.008.?
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