STABILITY INDICATING METHODS AND FORCED DEGRADATION STUDIES FOR PHARMACEUTICAL PRODUCTS SAFETY AND EFFICACY- AN OVERVIEW

Fatehalrahman F. Magbool*, Shayoub M. E.

ABSTRACT

Chemical stability of pharmaceutical molecules is a matter of great concern as it affects the safety and efficacy of the drug product. The FDA and ICH guidances state the requirement of stability testing data to understand how the quality of a drug substance and drug product changes with time under the influence of various environmental factors. Stability testing of drugs requires an accurate analytical method that quantifies active pharmaceutical ingredients (API) without interference from degradation products, process impurities and other potential impurities. Stability-indicating methods are traditionally performed using gradient elution, in order to ensure that degradants of various chemical compositions are all detected. Relevant stress conditions are light, heat, humidity, hydrolysis (acid / base influence) and oxidation or even a combination of described parameters. Stability-indicating HPLC methods are designed for drugs. Stability-indicating analytical method is validated, specific, and quantitative analytical method, which is capable of accurately testing API, degradation products, and other components of interest without interference. The stability-indicating method is used to detect the changes with time in the chemical, physical, or microbiological properties of the drug substance and drug product. The forced degradation studies are another very important part of the validation of the stability indicating method.

Keywords: Chemical stability, Stability testing, Degradation products, Forced degradation studies, Stability-indicating methods, Active pharmaceutical ingredients.