Teaching Analytical Method Transfer through Developing and Validating Then Transferring Dissolution Testing Methods for Pharmaceuticals

Document Type

Article

Publication Date

6-28-2017

Abstract

Analytical method transfer (AMT) and dissolution testing are important topics required in industry that should be taught in analytical chemistry courses. Undergraduate students in senior level analytical chemistry laboratory courses at Kennesaw State University (KSU) and St. John Fisher College (SJFC) participated in development, validation, and transfer of two dissolution testing methods for pharmaceuticals. These experiments were transferred between the two schools and underwent method equivalency testing by a different set of undergraduate students to validate the AMT. Student learning outcomes addressed at both SJFC and KSU include (1) significant learning gains across all 3 years of the study; (2) confidence in method development, writing standard operating procedures, and laboratory transfer of validated methods; (3) increased understanding of AMT and dissolution testing; (4) ability to operate dissolution testers, UV–vis, and flame atomic absorption spectrophotometers; and (5) improved knowledge and understanding of figures of merit and statistical analysis.

DOI

https://doi.org/10.1021/acs.jchemed.6b00878

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