OBTAINING QUANTITATIVE INFORMATION ON THE FLUCTUATION OF THE ACTIVE INGREDIENT CONTENT IN DRUGS – WHAT WOULD THE CUSTOMER FIND

Abstract

The active ingredient content of tablets is not uniform due to inhomogeneity and the fluctuation of the process circumstances. Moreover, the measured data are subject to measurement (analytical) error. Both the consumer and the producer should be aware of the possible range of active ingredient content of the tablets. The analysis of variance technique was used in the context of nested designs. Several variance components and their confidence ranges were calculated utilising the Satterthwaite-approximation. The customers may also control the product quality. Our purpose is to study the measurement process, as the customer would perform it, raising the question on the range in which the customer finds the amount of the key compound in a tablet purchased at a pharmacy. Various cases are compared concerning the measurement precision and way of chemical analysis performed by the customer, calculating the ranges in which the active ingredient content could be found with 95% probability. The width of these ranges may be affected by the bias of the Satterthwaite-approximation.