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.
Video Overview
Video Walk-through
- 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