#8593. Analytical Lifecycle Management (ALM) and Analytical Quality by Design (AQbD) for analytical procedure development of related substances in tenofovir alafenamide fumarate tablets

January 2027publication date
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Journal’s subject area:
Medicine (all);
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Abstract:
The aim of this paper was to develop a robust, regulatory-flexible, application-specific Ultra Performance Liquid Chromatography (UPLC) analytical procedure using the Analytical Lifecycle Management (ALM) and the Analytical Quality by Design (AQbD) for the estimation of the Tenofovir Alafenamide Fumarate (TAF) tablets.
Keywords:
Analytical Lifecycle Management (ALM); Analytical Quality by Design (AQbD); Design of Experiment (DoE); Prediction interval; Tenofovir alafenamide fumarate; Ultra Performance Liquid Chromatography (UPLC)

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