Determining the residual moisture content of a lyophilized pharmaceutical product is important for several reasons. First, the amount of residual moisture content is related to the stability of the formulation over the shelf life of the product. Second, moisture analysis of a statistically relevant sample set can give insight into the freeze-drying process itself.
Residual moisture determination can be used as a tool in process studies to confirm the efficiency, consistency, and robustness of a specific freeze-drying cycle that has been designed for a particular drug formulation. Unfortunately, the destructive nature of the traditional moisture determination methods (Karl Fischer titration and thermogravimetric methods) is a limitation that can lead to increased costs and limited insight into the stability and quality of freeze-dried product and drying cycles. Non-destructive moisture analysis can enable:
- Efficient analysis of statistical sample sets
- Ability to design and qualify drying processes in a less costly and more efficient manner based on robust statistical data
- Ability to directly correlate moisture to other critical product quality parameters
Download this webinar to gain insight into how nondestructive moisture determination can be used in lyo process development and product quality testing.