Pharmaceutical Testing laboratory participated in interlaboratory comparisons over the last three years for the analysis additive B in amoxicillin tablets with bias results of 2.4; 2.7;1.9;1.4;1.8 and 2.9. During that mentioned comparisons, the total number of participated laboratories were 34 with the mean standard deviation of 8.8. During the routine sample analysis, the laboratory has been conducting quality control with the control limit that was set to +/- 3.34% at 95% confidence interval. You are required to estimate the expanded uncertainty associated to the analysis of additive B (K=2).

Considering that the customer demand on expanded uncertainty is +/- 10%. What would be your conclusion on the estimated expanded uncertainty?

Answer