Document Detail

Net analyte signal based statistical quality control.
MedLine Citation:
PMID:  16285655     Owner:  NLM     Status:  MEDLINE    
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.
E T S Skibsted; H F M Boelens; J A Westerhuis; A K Smilde; N W Broad; D R Rees; D T Witte
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Analytical chemistry     Volume:  77     ISSN:  0003-2700     ISO Abbreviation:  Anal. Chem.     Publication Date:  2005 Nov 
Date Detail:
Created Date:  2005-11-15     Completed Date:  2007-04-02     Revised Date:  2009-11-19    
Medline Journal Info:
Nlm Unique ID:  0370536     Medline TA:  Anal Chem     Country:  United States    
Other Details:
Languages:  eng     Pagination:  7103-14     Citation Subset:  IM    
Biosystems Data Analysis, Swammerdam Institute for Life Sciences, University of Amsterdam, The Netherlands.
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MeSH Terms
Chemistry Techniques, Analytical / methods*,  standards*
Models, Chemical
Quality Control
Spectrum Analysis

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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