Application of QbD principles for the evaluation of empty hard capsules as an input parameter in formulation development and manufacturing.

AAPS PharmSciTech · 2014 · PMC4037476 · PMID 24526655

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showed a trendno p-value reported

The LOD level of the different batches showed a trend to be at the upper end of the specification defined as 13–16% water, which can be explained by the hysteresis properties of the gelatin polymer.

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