USP Course (I)
"Fundamentals of Dissolution: Guidance for the Verification and Qualification of a Dissolution Apparatus (with lab)"
This two-day theory and laboratory course will emphasize the fundamentals of dissolution testing of solid oral dosage forms with a focus on the qualification of USP dissolution apparatus 1 and apparatus 2. The first day will be dedicated to classroom learning on dissolution theory and the guidance presented in USP–NF General hapter <711>, the handling of dissolution data, and the qualification of an apparatus to prove its suitability for use. The second day will be a laboratory hands-on practice of the instrument qualification and conducting the Performance Verification Test (PVT).
Upon completion of this course, you will be able to
• Interpret the USP–NF and related dissolution chapters, its revision process, and USP’s perspective on dissolution
• Outline the history and theoretical basis of dissolution testing
• Explain key definitions of dissolution testing
• Interpret USP General Chapter <711>
• Set up, verify and qualify a dissolution apparatus (focus on apparatus 2)
• Use acceptance tables and handle sampling, calculation, and dissolution data
• Examine apparatus suitability
• Conduct Performance Verification Test