Dapagliflozin Inhouse Impurity B / Dapagliflozin Impurity 57, CAS 1662702-90-0, é o éter arílico 1-[(2-clorofenil)metil]-4-etoxibenzeno, com fórmula C15H15ClO e massa molecular de 246,73 g/mol. Estruturalmente, enquadra-se como impureza de प्रक्रिया clorada e lipofílica, não como espécie genotóxica reativa. Essas substâncias surgem tipicamente de benzilação incompleta, reações secundárias de eterificação ou arraste de matérias-primas clorobenzílicas durante a síntese de intermediários da dapagliflozina. A identificação e a quantificação geralmente exigem LC-MS, GC-MS e RMN, sendo GC-MS particularmente útil pela volatilidade e pelo caráter aromático hidrofóbico. No contexto regulatório, sua relevância está no perfil de impurezas e no controle de resíduos organoclorados de síntese.
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