Abstract

Correlations between some basic quality parameters of a drug product, which are very important for the pharmaceutical manufacture of solid dosage forms are studied, on the base of experimental data from 135 batches. Factor analysis, control charts and histograms are implemented for the quality parameters – strength of tablet, assay of the active substance, acid resistance, disintegration), water content, drug dissolution after 150 minutes and drug dissolution after 165 minutes.. The parameter drug dissolution after 120 minutes is dropped from the analysis, because it was observed to have a zero value for all measurements. The main aim of this article is to search for a possible underlying structure in the variables with exploratory factor analysis, to monitor whether the quality parameters’ variation is consistent and the empirical distributions of the most important quality parameters using control charts and histograms.