The application note demonstrates automated water content determination in pharmaceutical tablets by volumetric Karl Fischer titration. A homogenizer (high frequency mixer) is used to pulverize the pharmaceutical tablets. This avoids tablet crushing and accelerates the release of water.
Background
The water (moisture) present in tablets plays an important role in determining their stability at various stages of formulation. The presence of water in active pharmaceutical ingredients (APIs) and/or finished drug products can alter properties such as shelf life and performance.
In the final products, water may be present in various forms such as surface-bound, hydrated or absorbed.
A METTLER TOLEDO Excellence titrator, along with an InMotion Flex autosampler and KF InMotion Kit, is used for the analysis of total water content determination in the reported application.
This application note includes:
- Sample Preparation and Procedures
- Solutions and Chemicals
- Chemistry
- Instruments and Accessories
- Method in Detail
- Results and Remarks
It also includes method files in .lmt and .xml for direct import and implementation on the instrument.
