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Lecture 4: Dissolution Instrument Qualification - Performance Verification vs. Physical Calibration

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Learning Objectives:
  • Provide an overview of analytical instrument qualification.
  • Describe the qualification needed of the dissolution apparatus.
  • Outline the USP Performance Verification Test (PVT)1 and the alternative FDA Enhanced Mechanical Calibration test2.
  • Summarize how to investigate dissolution apparatus qualification failures and analyze which measurements should be made before each dissolution test.