Dissolution Testing

Lesson Code: PPL-1213. This e-Lesson is aimed at personnel who require an overview of how dissolution testing is performed in practice. It includes setting of operational parameters, preparation and addition of dosage forms, sampling, generation and treatment of data, and checking of results against specifications. Criteria for retesting are also explained.

  • Category: Analytical Laboratory - Practices

Description

After taking this e-Lesson, you will be able to:

  • List the operating parameters that are set on a dissolution apparatus
  • Describe the final preparation checks done before adding dosage forms to dissolution media
  • Describe how dissolution start time is handled for a Type 1 and Type 2 dissolution apparatus
  • Explain the difference between staggering and simultaneous dosage form addition
  • Describe the procedures involved in manual and automatic sampling
  • Perform calculations for concentration of active in the vessel, weight of active dissolved, and percent label claim
  • Compare results against USP acceptance criteria
  • List examples of when retesting can be performed