Header Artwork

Find a test

Forced Degradation

Forced degradation studies are used to identify reactions which may occur to degrade a processed product. Usually conducted before final formulation, forced degradation uses external stresses to rapidly screen material stabilities.

Forced degradation studies are performed by means of various stressing agents such as pH, temperature, light, chemical agents (e.g., oxidizing), and mechanical stress to speed up the chemical degradation, physical degradation, or instability of a molecule. Forced degradation studies show the chemical behavior of the molecule which in turn helps the development of formulation and package.

Nelson Laboratories uses force degradation studies to qualify method as stability indicating method. Stability indicating methods are specifically designed to separate drug degradants from non-degraded drug. The forced degradation studies are performed usually at the development stage of the stability indicating method. After the development is completed, validation is performed.

Applicable Standards

  • USP <1049>
  • ICH Q1A

Study Outline

In the force degradation study, the samples are exposed to stress conditions: Hydrolysis by acid and base, oxidation, thermal using heat and photolytic using photo stability chamber.

After the samples are exposed to each of the stress condition for the specified amount of time, the samples are tested for assay and purity and the impurities are calculated.

Testing Locations

  • Itasca, IL, USA

Learn more about our locations and their certifications.

If you have additional questions about Excipient Testing, or would like to consult with the experts at Nelson Labs, just send us a request or call our Fairfield, NJ facility  at +1 (973) 227-6882.