Fundamentals of Dissolution: Guidance for the Verification and Qualification of a Dissolution Apparatus (Classroom and Laboratory)

Event

Course Description:

This 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).

 

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

Who should participate:

  • Dissolution chemists
  • Analytical chemists
  • Laboratory technicians who are new to dissolution or need a refresher course on the topic

 

Registration Cancellation/Refund Policy: 
A USP Education course may be cancelled due to lack of enrollment, inclement weather or other unavoidable factors. In the event of a course cancellation for such reason, USP will provide a full refund to all registered participants. We will do our best to provide at least a two (2) week notice for classroom course cancellations. Please know that the USP-US office follows the closing policy of the federal government in the Washington DC metro area which can be checked here.