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Stability testing in drug development

The purpose of stability testing in drug development is to provide evidence on how the quality of an active substance or pharmaceutical product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light.

The first stability studies performed are usually forced degradation studies. These are carried out to understand the primary degradation products of the molecule and to aid analytical method development. The next stage is to perform accelerated stability testing for excipient compatibility studies during formulation development and to support assignment of initial shelf lives/storage conditions for early toxicological and clinical studies. Long-term stability studies will also be initiated on both the active pharmaceutical ingredient (API) and the drug product, generally following many of the principles contained in the ICH stability guidelines, with storage at accelerated and long-term conditions.

Forced degradation is routinely used in drug development to predict the stability of drug products that affects purity, effectiveness, and safety. In stress testing (forced degradation) the drug product is exposed to heat, light or chemical agents with the goals being:

  • understanding degradation pathways
  • determining the intrinsic stability and shelf-life
  • developing stable formulations
  • evaluating antioxidant efficiency

Electron Paramagnetic Resonance (EPR) spectroscopy can successfully detect and monitor short-lived free radicals produced during stress testing via chemical, thermal, or photochemical reactions. EPR can determine radical scavenging effectiveness and efficiency of antioxidants.

Within biopharma, mass spectrometry solutions can aid biotherapeutic decision-making and speed up the overall development timeline. Stability testing for post-translational modifications (PTM) via intact analysis in biopharmaceutical drug development results in rapid screening of biotherapeutic degradation products during storage, reduced risk of artifact introduction compared to peptide maps and true isotopic patterns that provide accurate quantitation.


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