Pharmaceutical manufacturers must establish the stability of their drug products towards light. But what makes a drug molecule or formulation unstable to light, and how can appropriate protection be given? Find out in this guest post from Dr. Mark Powell on photostability testing.
How do you set a retest period for a drug substance or shelf life for a drug product? How can extrapolation be applied to propose a retest period or shelf life for a drug product that extends beyond the period covered by real-time stability data? In this article, we outline how we can assist you with … Continued
Development phase Accelerated stability tests provide a means of comparing alternative formula-dons, packaging materials, and/or manufacturing processes in short-term experiments. As soon as the final formulation and manufacturing process have been established, the manufacturer carries out a series of accelerated stability tests which will enable the stability of the drug product or medical device to … Continued