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Summary

The physicochemical stability of paclitaxel and vincristine formulations (Ontax and Fauldvincri injection solutions, respectively), kept in their primary package container, was evaluated after perforating the vials for solution appearance, pH, drug identification, assay and particulate matter and also for degradation products for paclitaxel and related compounds for vincristine. Results showed no physicochemical significant alterations after perforation of vial when solutions of paclitaxel were stored at room temperature for 28 days and when solution of vincristine was kept in the refrigerator for 24 hours, both condition protected from light.

The solution of vincristine was diluted on sodium chloride 0.9% and the physicochemical stability was evaluated 24 hours after preparation kept at room temperature and 14 days after preparation kept in the refrigerator, protected from light. Solution appearance, pH, drug identification, assay and related compounds were performed for evaluation of dilution solution. No significant physicochemical alteration was observed on the diluted solution of Fauldvincri (1 mg/ mL) regardless the time the solution was stored after preparation (24 hours at room temperature or 14 days in the refrigerator).



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