Course Description
Major techniques applicable for the characterization and determination of pharmaceutical agents.
Athena Title
Pharmaceutical Analysis
Prerequisite
CHEM 2212 or permission of department
Semester Course Offered
Offered spring
Grading System
A - F (Traditional)
Course Objectives
Upon completion, students will understand and be able to explain the major techniques involved in the characterization of pharmaceutical agents. Students will also understand the techniques used to support drug development and clinical trials. Additionally, there will be an introduction to the role of regulatory affairs in the drug development process.
Topical Outline
Week 1: Quality Control - Accuracy and Precision; Linearity; Method Validation; SOPs; Basic Calculations Week 2: Physical & Chemical Properties – pKa; H-H; %Ionization; Dissolution; Partition Coefficients; Sterochemistry; Optical Rotation; Stability Week 3: Physical & Chemical Properties – Gravimetric; Surface Area; Polymorphs; Calorimitry Week 4: Titrations – Acid/Base; Non-aqueous; Redox; Potentiometric; Karl-Fischer Week 5: UV/Vis Spectroscopy – Instrumentation; Beer’s Law; Diode Array; Interpretation; Difference Spectrophotometry; Derivative Spectra Week 6: IR Spectroscopy – Instrumentation; Interpretation; Polymorphs; Near-infrared Spectroscopy Week 7: Molecular Spectroscopy – Instrumentation; Molecules that Fluoresce; Quenching; Raman Spectroscopy; Interpretation Week 8: NMR – Instrumentation; Proton; Carbon; 2-D; Interpretation Week 9: Mass Spectrometry – Instrumentation; Ionization; Interpretation; MS-MS Week 10: Chromatography – Capacity Factor; Efficiency; Partitioning; Band Broadening; Peak Shape Week 11: Gas Chromatography – Instrumentation; Column Chemistry; Derivatization; Detectors; Residual Solvent Analysis Week 12: HPLC – Instrumentation; Column Chemistry; Secondary Equilibrium; Detectors; Method Development Week 13: HPLC – Ion-Pair; Ion-exchange; Size-exclusion; Affinity; Normal Phase; HILIC Week 14: Other Separations – Thin Layer Chromatography; Electrophoresis; Capillary Electrophoresis; Week 15: Hyphenated Techniques: GC-MS; LC-MS; LC-NMR
Syllabus