Zeitschrift für Bioäquivalenz und Bioverfügbarkeit

Abstrakt

Stability of a Dosage Form and Forced Degradation Studies

Safila Naveed, Sania Basheer and Fatima Qamar

The stability of the pharmaceutical formulation during its entire shelf life in its final packaging is an important matter. Stability study does not only cover the physiochemical aspects of the drug but also explains the safety and efficacy of the product during its entire shelf life. Force degradation studies are the studies in which stress conditions or accelerated conditions are provided to the drug in bulk or product. For the development of stability indicating methods especially when insufficient information is accessible about degradation products and to obtain information about the degradation pathways and degradations products that might affect during storage conditions forced degradation studies are performed. Forced degradation studies help to facilitate pharmaceutical development, manufacturing, production and packaging where knowledge of chemical behavior can be used to improve drug product. An FDA and ICH regulatory body portrays the layout of these stability limitations for the stability and degradation point of view.