Homogeneity of Biochemical Analysis

Graphic representation of vitamin and amino acid levels supported consistency of the fluid bed manufacturing process at the various scales. The data shown in Figure 2 represent average values from the sampling protocol (Methods and Materials). The analytes represent constituents present in minute quantities (vitamins) and nutrients critical to medium performance (amino acids). The data are presented as percent of the direct weigh control, so that 100% represents the total amount of the vitamin or amino acid that was originally added to the formulation. Every test analyte from the 9kg, 90kg or 500kg lots exhibited its full complement of the theoretical and control vitamin and amino acid levels. Statistical analysis (ANOVA) of folic acid concentrations was performed on the 500kg lots 82 and 83 from top, middle and bottom sampling locations. At a 95% confidence level, no statistical difference existed for mean % of control values between drums (beginning, middle, end) or within drums (top, middle, bottom: data on Website).