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45 - PHR - Pharmaceutical Sciences

PHR 113 - Dissolution: Theory and Best Practices

Code Start Date Duration Venue
PHR 113 10 October 2022 5 Days Istanbul Registration Form Link
PHR 113 05 December 2022 5 Days Istanbul Registration Form Link
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Course Description

This course provides focused, relevant instruction on the fundamentals of pharmaceutical dissolution testing as described in The U.S. Pharmacopeial Convention (USP). Participants in this course will gain an overview of the theory, practice, and history of dissolution. They will learn the practical aspects of conducting dissolution tests, best practices, and performance verification testing.

Course Objectives

  • Understanding the Compendial dissolution testing
  • Understanding USP’s perspective on dissolution through historical highlights
  • Understanding how PVT acceptance criteria are established
  • Understanding the Performance Verification Testing
  • Understanding the Best Practices

Who Should Attend?

  • Pharmacists
  • Chemists and laboratory technicians
  • Anyone who performs dissolution testing in the laboratory
  • QC and product development professionals who review dissolution data.

Course Details/Schedule

Day 1

  • Introduction to Dissolution
  • Historical aspects
  • Overview of Performance Verification Testing
  • Dissolution and the USP
  • Dissolution Theory

Day 2

  • Performance Verification Testing
  • ISO/cGMP considerations
  • Instrument Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
  • IQ/OQ/PQ for Apparatus 1, Apparatus 2, and associated equipment/vessls

Day 3

  • Practical considerations of PVT
  • Best Practices
  • Performance Verification Testing
  • Testing of USP Reference Standards

Day 4

  • General Dissolution Testing
  • Variables
  • Analyst training
  • Sample Preparation

Day 5

  • Importance of filtration
  • Device configuration
  • Pore size and distribution
  • Chemical compatibility, drug binding and extractables