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  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica

Analytical Research and Development

 

Accelerated and forced degradation studies

So called Forced Degradation Study (FDS) is an integral part of validation of most of HPLC methods. It is a tool to check and evaluate methods which have been developed to be stability-indicating. The principle of FDS lies in stressing a drug (and the corresponding placebo) under physical and chemical conditions, which may force the sample to degrade rapidly thereby producing yet unknown impurities. The idea is to simulate the profile of impurities which may develop during a long-term storage of the product.

By physical and chemical stress, we mean:

  • Elevated temperature
  • Light exposure (UV/VIS)
  • Acidic, basic and oxidative conditions
  • Increased humidity

Particularly, a good knowledge of chemistry of the investigated API in presence of placebo is advantageous when seeking optimal conditions for chemical stressing within FDS. Our experience has shown that this type of work is  most effective when provided by the R&D department. For this very reason, since some time ago, our team has carried out FDS not only within the development of new methods, we have also designed and performed FDSs within a GMP validation of methods in cooperation with the department of pharmaceutical analysis.