Clarithromycin Impurity I (CAS 118058-74-5) | também referida como Des(cladinosyl) Clarithromycin ou 3-O-Decladinosyl-6-O-methylerythronolide A | é uma impureza relacionada observada no perfil de degradação da claritromicina; apresenta perda do resíduo cladinosil com consequente alteração de massa molecular e polaridade | exigindo métodos analíticos específicos para identificação. A caracterização e quantificação normalmente são realizadas por HPLC com detecção UV ou espectrometria de massas | com validação de sensibilidade | linearidade e robustez conforme monografias farmacopéicas. O monitoramento desta impureza é essencial para controle de qualidade | definição de limites de especificação e estudos de estabilidade de lotes.
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