Stability-Indicating Method Development by Waters

Manufacturer Waters
A Systematic Approach using pH and Column Selectivity Waters has designed a method development approach and accompanying four-column kit to establish stability-indicating methods that provide: step-by-step protocol comprehensive applications book reproducibility chromatographic selectivity column lifetime and sensitivity The need to save method development time and improve accuracy is forcing today’s analytical chemists to look for better, faster ways to develop stability-indicating m...


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Stability-Indicating Method Development


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A Systematic Approach using pH and Column Selectivity Waters has designed a method development approach and accompanying four-column kit to establish stability-indicating methods that provide:

  • step-by-step protocol
  • comprehensive applications book
  • reproducibility
  • chromatographic selectivity
  • column lifetime and sensitivity


The need to save method development time and improve accuracy is forcing today’s analytical chemists to look for better, faster ways to develop stability-indicating methods. Costly delays can be prevented by quickly establishing robust analytical methods that remain useful throughout the life of a drug product.

Benefits of the Waters approachSystematic steps

  • Reduce development time
  • Less than 1 week to complete work per compound
  • Common retention factors (k)*

Unique Selectivity

  • Maximize chances for best separation
  • Methods on “new generation” HPLC columns
  • Best peak shape
  • Excellent reproducibility
  • Run at low and high pH
  • Maximize selectivity differences
  • Work in pH zones that maximize robustness by
    running two pH units above or below the pka

Perform degradation studies

  • Challenge the method to ensure resolution of all potential impurities

Product Overview

Stability-Indicating Method Development by Waters product image

Stability-Indicating Method Development

Manufacturer Waters

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