Qualification of dissolution instruments has always been challenging. The performance of the apparatus can be influenced by variability in several mechanical properties of the apparatus. Recently, there have been significant changes in regulatory and compendial guidances related to the qualification of these instruments. Despite the recent advances, there are still challenging outstanding issues. For these reasons, it is imperative that organizations that are generating dissolution data understand the challenges associated with qualification of dissolution apparatuses, become aware of the recent changes, and take steps to address the changes in their operational activities.
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