Compound Degradation

Compound Degradation

Stated in the FDA and ICH guidance state

The study of the compound degradation is mandatory for drug products and drug substances as it is stated in the FDA and ICH guidance state. These studies are done to understand their behavior over time under multiple environmental conditions. These properties are key to decide about the formulation, packaging, storage conditions and expiration date of the potential new drugs.

There are two main levels to study compound degradation: long term stability studies (12 months) and accelerated stability analysis (6 month). Forced degradation can be used to get the degradation products in few weeks that later can be used later as standards in the long and accelerated studies. Therefore, forced degradation studies goals are study the degradation pathway of the product distinguishing between the degradation products coming from the drug itself and from the combination of the drug and formulation components, elucidate the structure of the compounds formed and compute the stability in the formulation.

The information from these studies can then be used to understand the drug properties, to obtain a better formulation of the final product and to obtain information that can be used in the long term and acceleration degradation studies that have to be introduce in the regulatory dossiers.


Chemist putting vial with a sample into autosampler of HPLC system. High performance liquid chromatography at chemical laboratory. Developing of pharmaceuticals or vaccine. Biochemistry analysis

Due to the nature of the expected outcomes from the degradation studies the Liquid Chromatography linked to a Mass Spectrometer detector might the technique of choice to first isolate the compounds formed and also to perform an initial structure elucidation based on the compound fragmentation that later can be fine-tuned using Nuclear magnetic Resonance.


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