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
COVID-19 Policy:For Classroom registrations, onsite attendees must be
fully vaccinated, as defined by the CDC, adhere to CDC guidelines on social
distancing, and state, local and USP mask requirements. We will continue to
monitor the COVID-19 pandemic as the course date approaches, and there is a
possibility that the in-person Classroom offering will be cancelled. If
this occurs, we will offer the option for a full refund or we can transfer your
registration to the virtual option. 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.