How formulation science connects with process, stability and performance

tools for process and lab

For a client in the pharmaceutical industry, we have worked with the very common problem of API precipitation. We have been able to help our client to take an important decision regarding manufacturing as well as given them further insight into how different process steps can affect end product stability as well as behavior.

We have used a combination of surface characterization and light scattering methods on samples from different stages in the manufacturing process; model samples as well as true samples from the industrial process. The surface characterization method in this case was QCM and the light scattering method was indeed an innovative way of analyzing data from a commercial DLS instrument..

The results pointed our client in a clear direction; the API could best be processed from a specific stock solution concentration. With other starting concentrations agglomeration is a problem.

Techniques used:

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