Stability-Indicating Method Development

Manufacturer Waters

Product Image

0 Scientists have reviewed this product

Write the First Review

No Reviews

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

Product Image

Stability-Indicating Method Development

Manufacturer Waters

Be the first to review this product