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Purpose of Forced Degradation Study

“Stress testing of the drug substance can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used.

The nature of the stress testing will depend on the individual drug substance and the type of drug product involved”.

From the regulatory perspective, forced degradations studies are performed:

  • To identify possible degradation products.
  • To establish degradation pathways and intrinsic stability of the drug molecule.
  • To validate stability-indicating analytical procedures.

When looking beyond ICH guidelines and looking into the literature and the current trends for forced degradation studies, the initial purpose of forced degradation studies is to understand drug molecule chemistry, to investigate stability-related properties:

  • “to identify impurities related to drug substances or excipients”
  • “to generate more stable formulations”.
  • “to distinguish degradation products in formulations that are related to drug API and to develop an understanding of the degradation products and pathways. Moreover , a selection of purposes for performing forced degradation studies "
  • “to elucidate the structure of the degradation products”.
  • “to develop and validate a stability-indicating analytical method” substances from those that are related to non-drug substances (e.g., excipients)”
  • “to solve stability-related problems (e.g., mass balance)”
  • “to generate a degradation profile that mimics what would be observed in a formal stability study under ICH conditions”.
  • “to facilitate improvements in the manufacturing process and formulations in parallel with accelerated pharmaceutical studies”.
  • “to choose the correct storage conditions, appropriate packaging and better understanding of the potential liabilities of the drug molecule chemistry”.

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