This course provides focused, relevant instruction on the fundamentals of pharmaceutical dissolution testing as described in USP. Gain an overview of the theory, practice, and history of dissolution. Learn the practical aspects of conducting dissolution tests, best practices, and performance verification testing.
• Understand the Compendial dissolution testing • Understand USP’s perspective on dissolution through historical highlights • Understand how PVT acceptance criteria are established • Understand the Performance Verification Testing • Understand 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.
• Introduction to Dissolution • Historical aspects • Overview of Performance Verification Testing • Dissolution and the USP • Dissolution Theory • 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/vessels. • Practical considerations of PVT • Best Practices • Performance Verification Testing • Testing of USP Reference Standards • General Dissolution Testing • Variables • Analyst training • Sample Preparation • Importance of filtration • Device configuration • Pore size and distribution • Chemical compatibility, drug binding, and extractable
NOT INTERESTED IN THIS COURSE?
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