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Summary

The physicochemical stability of doxorubicin formulations (Fauldoxo injection solution), kept in their primary package container, was evaluated after perforating the vials for solution appearance, pH, drug identification, assay, particulate matter and also for related compounds such as the presence of aglycone doxorubicin and individual impurity not related. Results showed no physicochemical significant alterations after perforation of vial when stored at room temperature for 7 days and when kept in the refrigerator for 15 days, both condition protected from light.
After perforating the vials (7 and 15 days), solution was diluted on sodium chloride 0.9% and the physicochemical stability was evaluated 48 hours after preparation kept at room temperature and protected from light. Solution appearance, pH, drug identification and assay for dilution solution were performed for evaluation of dilution solution. None significant physicochemical alteration was observed on the diluted solution of both formulations of Fauldoxo injection solution (10 mg/5 mL and 50 mg/25 mL), regardless the time the solutions were stored before dilution (7 or 15 days).



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