Appropriate storage conditions can only be assessed once a stability study has been conducted and it is never too early to start gathering stability data. Stability studies are a pharmacopoeial requirement and guidance is provided by regulatory authorities, including ICH.
This course provides a comprehensive review of the considerations relevant to developing a stability-indicating analytical method, principally focussing on analysis by HPLC. This three day course starts by anticipating likely degradation based on chemical structure. Consideration is then given to forced degradation (stress study) to produce likely degradants, followed by the selection of an HPLC method which is capable of resolving any degradants that have been formed. Finally, the course deals with optimisation and validation of the stability-indicating method.
Upon completion of this course, delegates will have learned what is necessary to develop and validate stability-indicating methods for drug substance and drug product to comply with international regulatory guidelines.
Who Should Attend?
Scientists working with HPLC who need to further their understanding of the technique in order to develop better methods faster. Scientists who have to validate HPLC methods in accordance with current internationally-accepted guidance. HPLC technicians working in R&D laboratories, quality control laboratories and stability testing laboratories. Managers with a responsibility for generating regulatory submissions
Course Programme
Overview of developing a stability-indicating method
- Regulatory framework
- What can go wrong on storage?
- Real-time, accelerated and forced degradation
- Chemical and photochemical decomposition
- Requirements for a stability-indicating analytical method
- Stress testing objectives
- Anticipation of likely degradation products
- Common degradation pathways
- Are degradation products likely to be isomers, enantiomers or diastereoisomers?
- Forced degradation (stress testing) of drug substance, as per ICH guidance
- How much degradation is enough? When do we stop?
- Note findings of stress-testing industry comparison
- Brief overview of HPLC theory
- Common modes of HPLC: Reversed and normal phase HPLC
- Different approaches to stability analysis using HPLC
- Determination of degradants and HPLC assay calculation
- Mass balance
- Is the method doing everything I need?
End of Day: Group discussion
