This course will emphasize the fundamentals of dissolution testing of solid oral dosage forms and address specifics related to the qualification of USP dissolution apparatus 1 and apparatus 2. Specifically, this course is dedicated to 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.

Subject area:
Drug Products & APIs

Objectives (If applicable):
– Understand the theory of dissolution testing presented in USP–NF General Chapter <711> to apply in practical application
– Explain key definitions of dissolution testing
– Set up, verify and qualify a dissolution apparatus (focus on apparatus 2)
– Use acceptance tables
– Explain the operational parameters of a dissolution apparatus that could affect dissolution results

Target Audience (If applicable):
•Dissolution chemists
•Analytical chemists
•Laboratory technicians who are new to dissolution or need a refresher course on the topic
•Regulatory professionals