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This two-day course augments the classroom lecture in USP’s Dissolution Basics course with one day of hands-on laboratory training. It covers the fundamentals of dissolution testing with the objective to support the dissolution scientist in understanding the importance and fundamentals of dissolution. The focus is on dissolution tests conducted on either Apparatus 1 or Apparatus 2 per USP General Chapter <711>. The added opportunity of hands-on training allows participants to conduct a dissolution test under the guidance of USP staff.
Who Should Attend?
- Dissolution chemists
- Analytical chemists
- Laboratory technicians who are new to dissolution or need a refresher course on the topic
A revision of the former “Dissolution: Theory and Best Practices” course, 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 Chapter <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).
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
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