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Chromatographic system suitability tests--what should we be using?

J C Wahlich1, G P Carr

  • 1Glaxo Group Research, Ware, UK.

Journal of Pharmaceutical and Biomedical Analysis
|January 1, 1990
PubMed
Summary
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System suitability tests ensure chromatographic methods remain reliable after validation. This paper reviews traditional checks, questions their effectiveness, and suggests improved methods for ongoing analytical performance.

Area of Science:

  • Analytical Chemistry
  • Chromatography

Background:

  • System suitability tests (SSTs) are crucial for validating chromatographic methods.
  • Ensuring analytical method reliability over time is essential in regulated environments.

Purpose of the Study:

  • To critically evaluate traditional system suitability tests in chromatography.
  • To propose enhanced SSTs for improved analytical method monitoring.

Main Methods:

  • Review of existing literature and common practices for chromatographic SSTs.
  • Analysis of the limitations and appropriateness of traditional SST parameters.

Main Results:

  • Traditional SSTs may not adequately guarantee method performance.
  • Certain commonly used checks might be insufficient for detecting method drift.

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Conclusions:

  • Recommendations for alternative or supplementary SSTs are provided.
  • Implementing improved SSTs can enhance the robustness and reliability of chromatographic analyses.