Stability testing is an essential part of drug development which ensures the quality, safety and efficacy of the drug for the lifetime of the drug product.
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 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.
Upon completion of this course, delegates will have learned what is necessary to develop a stability-indicating method for drug substance and drug product to comply with international regulatory guidelines.
Course Programme
Overview of developing a stability-indicating method
BOOK this course with 'HPLC Analytical Method Development and Validation' for a reduced fee:
Early-bird fee: 3 day course 拢1440.00 (+ VAT if applicable, see notes on VAT)
For registering and paying by 26 April 2017
Full Fee: 3 day course 拢1620.00 (+ VAT if applicable, see notes on VAT)
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 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.
Upon completion of this course, delegates will have learned what is necessary to develop a stability-indicating method for drug substance and drug product to comply with international regulatory guidelines.
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?
BOOK this course with 'HPLC Analytical Method Development and Validation' for a reduced fee:
Early-bird fee: 3 day course 拢1440.00 (+ VAT if applicable, see notes on VAT)
For registering and paying by 26 April 2017
Full Fee: 3 day course 拢1620.00 (+ VAT if applicable, see notes on VAT)
