Boring Bliss

The content uniformity values are even further reduced relative to the assays, which is probably due to the sample work-up with very small amounts of drug. 

If only one drug had been formulated, then this B vs. A plot would not have been possible part of the information would have been accessible by plotting A V5. weight, though, see file ASSAY AB.xls 

Example 64 There are long lists of numbers. (See Table 4.42 and 4.43.) There is a discussion that sets the important results in perspective (state of the art, previous methods or revisions, expectations, specification limits). 

The HPLC method for which data are given had previously been shown to be linear over a wide range of concentrations what was of interest here was whether acceptable linearity and accuracy would be obtained over a relatively narrow concentration range around the nominal concentration in the product the specification limits were 90-110% of nominal. Three concentrations were chosen and three repeat determinations were carried out at each. Two different samples were prepared at each concentration, namely an aqueous calibration solution and a spiked placebo. All samples were worked up according to the method and appropriate aliquots were injected. The area counts are given in the second, respectively the fifth column of Table 4.42. 

Calibration Samples Spiked Samples f-Tests 

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