Development of Stability-Indicating HPLC Methods

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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.

Who Should Attend?

Scientists who need to develop methods for stability testing with maximum efficiency. Scientists who have to produce validated stability-indicating HPLC methods in accordance with current internationally-accepted guidance. HPLC technicians working in R&D 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"

Workshop: Anticipation of likely degradation products

  • 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

HPLC Methods

  • 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

Essentials of the stability-indicating HPLC method

  • Is the method doing everything I need"

Workshop: Selecting the Separation Mode for a Stability Indicating HPLC Method and Consideration of Detection Issues

Group discussion

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