Stability studies are used to assess the shelf life of a product by storing samples under differing conditions, typically as defined by regulatory authorities, and then testing samples taken from ...

Pharmaceuticals need to be assessed for stability to support the assigned shelf life. Therefore, when analysing stability samples obtained from these studies, analytical methods are required which are ...

What are stability indicating methods? Why do we use stability indicating methods? How could it help solve problems and what answers could it give? When do we use stability indicating methods? What ...

The authors discuss three methods for identification of out-of-trend (OOT) results and further compare the z-score method and the tolerance interval in OOT analysis for stability studies. It is ...

Stability indicating methods are indispensable in drug development. These are adopted primarily to give substantiate the variances in drug quality with environment. A drug is sensitive to humidity, ...

This article looks at the use of bracketing and matrixing to lower the number of stability samples required and, consequently, reduce the cost of sample production, testing and management. There is a ...