Capecitabine Impurity 12 (CAS 76497-54-6) é um derivado triacetilado do açúcar | identificado como (2R | 3R | 4R | 5R)-5-metiltetrahidrofurano-2 | 3 | 4-triol triacetato e conhecido também como 5-deoxi-1 | 2 | 3-triacetil-5-deoxi-alfa-D-ribose. Como impureza de processo | apresenta propriedades físicas e cromatográficas distintas | maior lipofilicidade e susceptibilidade à hidrólise sob condições ácidas ou básicas. É caracterizável por HPLC com detectores UV e MS | e confirmável por RMN e espectrometria de massa mediante padrões de fragmentação específicos. A quantificação e o controle desta impureza são essenciais para o perfil de impurezas conforme ICH | orientando limites | estudos de estabilidade e estratégias de purificação durante o desenvolvimento do produto.
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