Forced Degradation Testing

Forced Degradation Studies

Forced degradation studies allow us to produce stability indicating methods for our clients. Per ICH Q1A (R2) guidelines, the following stressor conditions should be evaluated depending on the type of drug substance or drug product:

  • Photolytic Degradation
  • Acid/Base
  • Oxidation
  • Thermal
  • Thermal/Humidity

Let Galbraith Laboratories discuss the scope of your project, techniques available, and the timeframe needed. Our expert chemists will design a custom study plan to address the unique characteristics of your API and project. Upon completion of the study a custom report will be provided targeted at your research and/or regulatory needs.


Example Instrumentation


High Performance Liquid Chromatography is one of the most common tools for purity analysis by allowing the user to separate and examine the API from excipients or contaminants. When coupled with Diode-Array Detection, all degradants with UV spectra can be viewed in a single run, and the full peak spectra can be used to confirm that the method is correctly separating the main APIs from degradants, ensuring that no co-elution is occurring from unknown compounds.



Gas Chromatography is a common tool for targeting volatile and semi-volatile degradation products or APIs. Mass spectrometry using electron ionization creates fragmentation pattern “fingerprints” which can often be compared against a compound database, such as NIST, for identification or to provide insight into novel unknown compounds.


Photostability Chamber

Photostability and photodegradation studies provide critical knowledge of the sensitivity of the material to light exposure over time. Depending on the material, a forced degradation study may require a non-standard amount of irradiation to reach sufficient degradation. Our Weiss PharmaEvent photostability chamber can be programmed to meet a wide range of custom light conditions to meet the needs of your forced degradation study plan.


Benefits for Method Development and Validation

Forced degradation studies enhance any method validation effort to achieve a stability indicating method. Stability indicating methods are often required for full compliance when performing a long-term or accelerated stability study.

Conditions that stress a material are often done during method development to gain a better understanding of the material breakdown pathways. When stress conditions are applied, the samples and controls can be tested by a series of techniques to see if different degradants are produced under differing stress conditions. These degraded solutions are then used to test that an analytical method is truly selective to only the original API. Once separation is achieved and a stability indicating method is available, method validation can go forward and produce more accurate and precise results for improved performance and insights.

Reach out to us for more information on our forced degradation services.