La impureza Citalopram EP Impurity D, también denominada escitalopram EP Impurity D, Citalopram Related Compound D y clorhidrato de N-desmetilcitalopram, corresponde a una impureza de amina secundaria básica asociada con O-desmetilación o metilación N incompleta durante la síntesis, y también puede formarse por desmetilación metabólica o de proceso. CAS 1188264-72-3; fórmula C19H20BrFN2O; peso molecular 391,28 g/mol. Como sustancia relacionada estructuralmente y no como nitrosamina, su relevancia se centra en el perfil de impurezas, el contexto enantiomérico y el control del proceso conforme a especificaciones farmacopeicas. Su identificación suele requerir LC-MS/MS, HPLC con separación quiral o por par iónico y, para confirmación a nivel traza, HRMS o RMN.
Referencias
Kaleemullah Tarkatti, et al. “Reverse Phase Liquid Chromatographic Method for the Quantification of Di-p-Toluoyl-d-Tartaric Acid In…” ResearchGate, unknown, 15 Oct. 2011, www.researchgate.net/publication/225091124_Reverse_Phase_Liquid_Chromatographic_Method_for_the_Quantification_of_Di-p-Toluoyl-d-Tartaric_Acid_in_Escitalopram_Oxalate_Drug_Substance.
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