FORCED DEGRADATION TRAINING COURSE
This training provides an overview of the forced degradation process. It explains 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.
This course is suitable for anyone requiring an overview of the forced degradation process and practical aspects of the analytical support of samples.
FORCED DEGRADTION COURSE DETAILS
- 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
We offer flexible delivery options for this instructor-led course:
- On-site: one half day at lab or any location of your choice.
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Online: one half day.
View our online training calendar for upcoming dates.
Delegates should have some experience of HPLC, but background in forced degradation is not essential.
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Stability Indication and Impurities. Forced degradation study and limitations
- Regulatory guidelines
- Shelf life considerations
- Limitations
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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)
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Forced degradation experiments
- pH
- Photolytic
- Oxidative
- Thermolytic
- Limitations
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Peak Purity Evaluation
- Peak purity approaches
- Peak purity limitations
- DAD data illustration
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Mass Balance
- Relative response factors
- Mass balance calculations and limitations
