Not Perfect, but Workable

Calibration Each of the solutions is injected once and a linear regression is calculated for the five equidistant points, yielding, for example, Y = -0.00064 + 1.004 X, = 0.9999. Under the assumption that the software did not truncate the result, an r of this size implies a residual standard deviation of better than 0.0001 (-0.5% CV in the middle of the LO range use program SIMCAL to confirm this statement ) the calibration results are not shown in Fig. 4.39. 

Repeatability Fiveteen placebo tablets are dissolved in water and spiked with the appropriate amount of a stock solution LO and/or HI so as to obtain the same concentrations of A and B as for the calibration solutions. Aliquots of each of these solutions are injected three times, for a total of 45 results of A and 45 for B. 

Content Uniformity Ten tablets per formulation are worked up one by one and aliquots of the so obtained solutions are injected. 

In Fig. 4.39, results for spiked placebo and for the verum tablets are given for compound A (bold lines) and B all horizontal bars should be at 100%, and the vertical lines should be centered at the same height. The gray trendlines, particularly for the LO- and Hl-range A-values indicate a systematic difference in response between tbe calibration solutions and the spiked placebo tablets (extraction efficiency, interference, etc.). For same ranges, the verum-tablets assays either underestimate the content of A by 4—5%, or A is underdosed. For compound A the repeatability figures are as follows (%-of-nom-inal, see file Fig4 39.dat), see Table 4.36. 

Concentration Assay Mean (Std.Dev.) Within- Group Residuals 

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Any workable theory of adhesion must take into consideration all of the possible aspects of energy transfer across an adhesive joint, not only molecular forces or ideal adhesive strengths, but also the presence, number, and size of flaws, various energy dissipation processes, and irreversible fracture processes. It has already been demonstrated that in an ideal situation, forces of molecular interaction should be sufficient to produce a very strong adhesive joint, assuming perfect contact across the interface, but that reality lies far from the ideal. 

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