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Net analyte signal based statistical quality control

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Author: Skibsted, E.T.S. · Boelens, H.F.M. · Westerhuis, J.A. · Smilde, A.K. · Broad, N.W. · Rees, D.R. · Witte, D.T.
Type:article
Date:2005
Institution: TNO Kwaliteit van Leven
Source:Analytical Chemistry, 22, 77, 7103-7114
Identifier: 238814
doi: doi:10.1021/ac048138d
Keywords: Research · Analytical research · Drug products plants · Infrared spectroscopy · Matrix algebra · Quality control · Statistical methods · Active pharmaceutical ingredients (API) · Net analyte signal based statistical quality control (NAS-SQC) · Quality parameters · Water content · Signal processing · excipient · gelatin · mannitol · piroxicam · analytic method · article · calculation · drug formulation · infrared spectroscopy · quality control · regression analysis · statistical analysis · statistical model · tablet formulation · Chemistry, Analytical · Computers · Models, Chemical · Quality Control · Spectrum Analysis

Abstract

Net analyte signal statistical quality control (NAS-SQC) is a new methodology to perform multivariate product quality monitoring based on the net analyte signal approach. The main advantage of NAS-SQC is that the systematic variation in the product due to the analyte (or property) of interest is separated from the remaining systematic variation due to all other compounds in the matrix. This enhances the ability to flag products out of statistical control. Using control charts, the analyte content, variation of other compounds, and residual variation can be monitored. As an example, NAS-SQC is used to appreciate the control content uniformity of a commercially available pharmaceutical tablet product measured with near-infrared spectroscopy. Using the NAS chart, the active pharmaceutical ingredient (API) content is easily monitored for new tablets. However, since quality is a multivariate property, other quality parameters of the tablets are also monitored simultaneously. It will be demonstrated that, besides the API content, the water content of the tablets as well as the homogeneity of the other compounds is monitored. © 2005 American Chemical Society.