Table IV

Average ICP-MS Concentrations for Vials Autoclaved and Stored in Water for Injection (WFI) at 25°C for 8 Weeks

Values shown in italics indicate the detection limit of the ICP-MS method; in those cases, standard deviation values are not applicable. Sn is not included in the table because it was not detected in any of the samples at any temperature (detection limit for Sn is 0.01 ppm).

ug/gAluminosilicateBorosilicate A Vial ABorosilicate B Vial BBorosilicate B Vial EBorosilicate B Vial F
MeanPooled SDMeanPooled SDMeanPooled SDMeanPooled SDMeanPooled SD
Al0.070.020.710.130.120.010.030.010.070.01
B0.201.820.120.200.200.20
Ca0.160.060.200.030.120.060.080.020.190.05
K1.130.050.450.020.050.070.010.060.02
Mg0.100.010.100.000.010.010.080.00
Na0.700.043.180.123.790.062.480.051.200.04
Si1.210.118.610.431.750.150.370.010.950.16