Developing Analytical Chromatographic Methods for Pharmaceutical Stability Investigations

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Thomas Swann
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Application Notes
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Application Notes
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Forced Degradation

This application describes a case study where a Quality by Design (QbD) approach was used to develop an analytical stability indicating method for monitoring degradation of amoxicillin powder for oral suspension.

A Quality by Design approach was illustrated, leveraging the software assistance of Fusion QbD to select factor value combinations, create acquisition methods, and evaluate modeled responses. The resulting Stability Indicating Method has sufficient resolving power to separate the worst case mixture of analytes afforded by a forced degradation sample. This gives confidence that this SIM will be able to separate whatever degradants arise during long term and accelerated pharmaceutical stability investigations.

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