STABILITY STUDY – FORCED DETERIORATION

Forced Degradation is the study used to obtain the “potential” degradation profile and to develop the indicative method of stability of a pharmaceutical product.

The study foresees the exposure of the Active Pharmaceutical Ingredient (API) and of the finished product to stress conditions (light intensities, temperature, humidity, acid and basic hydrolysis, oxidation) that can form substances from the API degradation reactions or API with excipients reactions from the finished product.

In Brazil, according to RDC NO 53/2015 – the most recent version of the Resolution—, the forced degradation testing became one of the necessary tests for the complete study of drug stability approved by the Brazilian Health Surveillance Agency (ANVISA).

“XIV–Forced degradation testing – Tests carried out to assess the intrinsic stability of the API as part of the development strategy, executed under more severe conditions than the ones used in the accelerated stability testing.” Source: ANVISA

SOLUTIONS OFFERED

  • Elaboration of forced degradation protocol;
  • Theoretical prediction of possible reactions of degradation of the drug and medication;
  • Identification of degradation products that are above the specified limits, under conditions of stability
  • Obtainment of the degradation product by isolation or synthetically, with further analysis to characterize it;
  • Elaboration of a validation protocol.

And other options upon request.