Abstract：
:A System Suitability Test (SST) is a test to verify the adequate working of the equipment used for analytical measurements. In pharmaceutical analysis, SSTs are performed at least at the beginning of a series of routine analyses. The most generally applied SST considers the precision of the analysis, i.e. the repeatability standard deviation must not exceed a predefined value. Additionally, a SST can also consider responses indicative for the quality of the technique used, e.g. resolutions between peaks or peak asymmetry in high performance liquid chromatography. The system is then only declared suitable if the response is within given limits. However, it is not always evident how to define the SST limits to be fulfilled for a newly developed method. Robustness tests have been proposed as a starting point in a strategy to deduce these limits. Here, it is examined how such a strategy can be applied for complex samples of microbial origin.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Hund E,Vander Heyden Y,Massart DL,Smeyers-Verbeke Jdoi
10.1016/s0731-7085(02)00470-3subject
Has Abstractpub_date
2002-11-07 00:00:00pages
1197-206issue
4eissn
0731-7085issn
1873-264Xpii
S0731708502004703journal_volume
30pub_type
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journal_title：Journal of pharmaceutical and biomedical analysis
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