large image
Loading...

Forced Degradation

1 Day

This training gives a comprehensive overview of the forced degradation process

This course will look at why forced degradation is so important to stability indicating methods and where it fits into the method development and validation cycle.

We will examine the associated regulatory guidelines and how these translate into a practical experimental design. In particular we explore the limitations of forced degradation and how we minimise these in a practical setting. Detector choice, challenges with mass balance and peak purity are also considered.

 
  • The background of why forced degradation is done
  • The limitation of UV/DAD detection
  • Typical forced degradation experiments
  • How to determine peak purity and mass balance

Stability Indication and Impurities

Forced degradation study and limitations

  • Regulatory guidelines
  • Shelf life considerations
  • Limitations

Overview of common degradation mechanisms

Specificity, Detection and impurity visualisation

  • UV and PDA Detection
  • Selectivity
  • Other detectors
  • Fluorescence
  • Refractive Index (RI)
  • Electrochemical
  • Evaporative Light Scattering (ELSD)
  • Charged Aerosol Detection (CAD)
  • Mass Spectrometer (MS)

 Forced degradation experiments

  • pH
  • Photolytic
  • Oxidative
  • Thermolytic
  • Limitations

Peak Purity Evaluation

  • Peak purity approaches
  • Peak purity limitations
  • DAD data illustration

Mass Balance

  • Relative response Factors
  • Mass balance calculations and limitations

Suitable for anyone requiring an overview of the forced degradation process and practical aspects of the analytical support of samples. Delegates should have some experience of HPLC, but background in forced degradation is not essential.

Understanding HPLC

Analytical method validation

Copyright © 2022 Crawford Scientific