1 and 20 mg/mL in PVC bags [11], known to be stable up to 48 h at 37 °C, up to 96 h at 25 °C and up to 7 days between 2 and 8 °C in solution could be used. However, no stability data are available concerning this active substance in these devices. As changes in the concentration did not reveal any degradation products similar to those observed during stress testing, whereas precipitation was observed, we investigated the precipitation phenomenon. 3.3 Precipitation Phenomenon 3.3.1 Reliability INCB024360 price of the Precipitate Recovery Method Normalised etoposide data after quantification of the wash solution (L1 and L2) yielded the following results.

For solutions in NaCl 0.9 % (samples 1–3), the average etoposide concentration found in L1 was 7.3 % of the initial concentration and 3.3 % for L2. For solutions in D5W (samples 4–6), the average etoposide concentration found was 19.5 % of the initial concentration for L1 and 3.2 % for L2. Using this method, overall recovery was

102.1 and 97.9 % of initial content of etoposide in D5W and NaCl 0.9 %, respectively. Moreover, less than 4.0 % of the initial content BYL719 research buy of etoposide was found in the second wash elution, indicating a 96.0 % extraction yield for our method. Thus, the recovery method was considered reliable for our purpose. 3.3.2 Results of the Precipitation Phenomenon The quantitative results of the study are presented in Table 6, taking into account a confidence interval of ±5 % (i.e. [95, 105 %] of the nominal value) for the concentrations. For the sake of simplicity, by definition, the value of 100 % represented the concentration values observed at H0. The same retention time (6.97 min) found for each

assayed solution indicated that the substance forming the precipitate and that in the solution were the same compound (i.e. etoposide). This showed that the precipitate found in the devices was etoposide, as previous studies suggested. We observed a precipitate Branched chain aminotransferase at H24 for the six devices prepared. Table 6 Distribution of etoposide in solution and in its precipitate form (600 mg/L) Time Etoposide amount in % Time Etoposide amount in % NaCl 0.9 % H0 Solution H24 Precipitate H24 Sum of etoposide amounts H24 D5W H0 Solution H24 Precipitate H24 Sum of etoposide amounts H24 Sample 1 100 36.6 63.7 100.3 Sample 4 100 43.8 54.5 98.2 Sample 2 100 37.4 64.9 102.3 Sample 5 100 41.1 56.5 97.6 Sample 3 100 36.9 67.0 103.9 Sample 6 100 42.3 55.6 97.8 For solutions in NaCl 0.9 % after 24 h, the amount of etoposide (L1 + L2) in solution (SNaCl) represented an average of 37.0 % of the initial etoposide concentration, while the concentration from the precipitate (PNaCl) represented an average of 65.2 % of the initial etoposide concentration. For solutions in D5W after 24 h, the amount of etoposide (L1 + L2) in the solution (SD5) represented an average of 42.