COURSE OVERVIEW
Who is this course for?
Suitable for anyone requiring an overview of the forced degradation process and practical aspects of the analytical support of samples.
Previous Knowledge
Delegates should have some experience of HPLC, but background in forced degradation is not essential.
What you will learn
- 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
COURSE OUTLINE
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
- pH
- Photolytic
- Oxidative
- Thermolytic
- Limitations
Mass Balance
- Relative response Factors
- Mass balance calculations and limitations