How to carry out a force degradation study?
In general, to carry out a force degradation study it is necessary to establish the drug product purity, identify the concentration range in which degradation occurs and select an appropriate time frame within which degradation will occur. The purity of the drug product can be determined by techniques such as High Performance Liquid Chromatography (HPLC), Gas Chromatography/Mass Spectrometry (GC/MS) or Nuclear Magnetic Resonance Spectroscopy (NMR). Once the purity has been established, the concentration range over which degradation will occur can be chosen based on information gathered during screening trials or previous pharmacokinetic studies. Finally, the time frame within which degradation will occur must be selected so that data collected during the study will provide meaningful results.