Distributions of results of cetirizine dihydrochloride assay in bulk material

The distribution of the cetirizine dihydrochloride assay results in correla tion with the pharmacopoeia limits is analyzed. The data for analysis M wer e obtained at Chemagis Ltd., Israel, for 13 batches during a year in two la boratories by five analysts using three different titroprocessors (total 11 4 results of the determination). The hypothesis on the normal distribution of the data was tested using omega (2)-criterion and accepted at the level of confidence 0.90. A control chart is designed for indication of warning a nd action limits of the determination results and for diagnoses of outliers in the further titrations. The distribution of the analyte content in diff erent batches and the distributions of the titration results: at the pharma copoeia limits were plotted. The probabilities of the erroneous decisions o f Type 1 and Type 2 on the batch quality were calculated from these distrib utions. (C) 2001 Elsevier Science B.V. All rights reserved.