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Establishing column batch repeatability according to Quality by Design (QbD) principles using modeling software.

Norbert Rácz1, Róbert Kormány2, Jenő Fekete1

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Intelligent modeling software assessed batch-to-batch repeatability for BEH columns, finding >98% robustness for separations. This ensures consistent results regardless of column batch or packing.

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Area of Science:

  • Analytical Chemistry
  • Chromatography
  • Chemical Engineering

Background:

  • Column technology requires ongoing advancements for consistent analytical performance.
  • Evaluating batch-to-batch repeatability is crucial for reliable chromatographic separations.
  • Intelligent modeling offers new approaches to assess column performance.

Purpose of the Study:

  • To evaluate the batch-to-batch repeatability of BEH (Ethylene Bridged Hybrid) columns.
  • To assess the robustness of chromatographic separations using retention modeling.
  • To determine if consistent separation conditions can be achieved across different column batches.

Main Methods:

  • Twelve BEH columns from different batches were analyzed.
  • Retention parameters including gradient time, temperature, and pH were measured.
  • Intelligent modeling software and a robustness module were employed for analysis.

Main Results:

  • Batch-to-batch repeatability of BEH columns was successfully evaluated.
  • Robustness analysis showed a >98% success rate across predicted experiments for all columns.
  • Packing quality was assessed through parallel measurements on columns from the same batch.

Conclusions:

  • High batch-to-batch repeatability was confirmed for the evaluated BEH columns.
  • Retention modeling enables robust separations independent of column batch or packing.
  • The developed methods ensure consistent analytical outcomes and reliable experimental conditions.