Valoración (Assay): 500 mg de claritromicina por vial, polvo para solución para infusión, con referencia a Klaricid (Abbott)
Perfil de impurezas: Controlado según ICH Q3A/Q3B; documentación CTD de la UE disponible
Clarity of Solution: La solución reconstituida cumple con los requisitos de claridad farmacopeicos para uso en infusión intravenosa

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Clarithromycin 500 mg per vial, powder for solution for infusion, referencing Klaricid (Abbott). Clarithromycin offers a longer serum half-life and better tissue penetration than erythromycin, allowing twice-daily dosing for most common infections. As a powder for solution for infusion, it is used whenever parenteral therapy is needed to treat susceptible-organism infections of the lower and upper respiratory tract, as well as skin and soft tissue infections. EU CTD dossier is available, with stability data covering Zone II and Zone IVb, a three-year shelf life, batch size of 20,000 vials, and packaging of one vial per box.