The European Pharmacopoeia (Pharm. Eur.) gives some hints in chapter 1.2 (Other provisions applying to general chapters and monographs) with referring to analytical procedures: There are also some definitions in the WHO Guidance: Ambient temperature: Store at the surrounding temperature. This term is not widely used due to significant variation in ambient temperatures. …
Forced degradation is not that simple as it seems where you just degrade with Acid, base, oxidation, light, light and present the data in a table form. It is elaborate study where we evaluate each or every impurity and discuss the potential risk. It is also a risk assessment tool. It goes beyond stressing the…
In ANDA submissions, the FDA typically requires stability data for at least 180 days. This data is a part of the chemistry, manufacturing, and controls (CMC) section of the application. The purpose of stability studies is to demonstrate the drug product’s stability over time, ensuring its quality and efficacy throughout its shelf life. This…
1. Accelerated stability studies These studies involve subjecting the pharmaceutical product to higher temperatures and humidity levels than normal storage conditions to determine its stability over a shorter period of time. 2. Long-term stability studies These studies involve storing the pharmaceutical product under normal storage conditions for an extended period of time, typically up…
