CHM 3510 - Advanced Analytical Chemistry

• Explain the implications of reporting results to fixed decimal places compared to using significant figures
• Describe the fundamental concepts in chromatography, expanding on fundamentals of thermodynamic and intermolecular force concepts
• Explain the appropriate identification and demonstrate the proper use of internal standards in quantitative analysis, expanding on fundamentals of thermodynamic, quantum chemistry, and intermolecular force concepts
• Apply the proper use of Beer's Law to "real world" commercial product analysis
• Implement iterative design skills and techniques into sample preparations, including the proper use of internal standards in quantitative measurements
• Investigate and explain the chemical reasons limiting the identification, detection, and quantitation of compounds, related substances, and contaminants
• Demonstrate proficiency in technical communication, extending to the submission of documents to regulatory bodies and other competent authorities
• Explain and demonstrate the appropriate use and execution of method validation topics: linearity, accuracy, specificity, limits of detection and quantitation, as they apply to test methods used in regulated industries and submitted for approval by regulatory bodies and other competent authorities
• Demonstrate an understanding of the major steps in the experimental design for test methods, specifically sample preparations for assay and related substance quantitation, as related to developmental and commercial products and samples including
  • controlled drug delivery
  • wipes, swabs, aerosols, other dosage forms
  • natural products
  • environmental samples

• Acid/base chemistry and buffers
• Molecular structures and intermolecular forces
• Solubility, boiling points and physical characteristics of chemicals and compounds

• Titration review, acid/base equilibrium
• Chromatography
• Mass spectrometry for in-process testing and low-level component quantitation    
• Near Infrared (NIR) spectrometry for in-process testing quantitation
• Analytical chemistry needs for different types of test methods as dependent on the purpose of the method
• Experimental design for test methods, specifically sample preparations for assay and related substance quantitation
• Error analysis - more detail
  • Lab investigations (out-of-specification, out-of-trend results)
  • Manufacturing investigations
  • Design of experiments to confirm error hypothesis
• Data reporting - sig figs vs. decimal points
  • Data reporting in a cGMP (Current Good Manufacturing Practices) industrial environment, including product in-process testing, assay testing, related substance and/or contaminant testing
  • Data reporting for product research and development activities, process development and validation, or test method development and validation as submitted to regulatory bodies or other competent authorities
• Formal lab reports and other documents for submission to competent authorities
  • Ways to properly address unexpected data due to human error, uncontrolled variables, inappropriate assumptions, or bad product
  • How to handle investigations - expectations of regulatory bodies and competent authorities

• Gas chromatography
• Titration - pick an indicator and assess sample
• Titration - standardization, quantitation, error assessment
• Over the counter pharmaceutical (OTC) product assay - UV-Visible spectroscopy and Beer's Law
• Experimental design around the picking of an internal standard - liquid chromatography, gas chromatography or mass spectrometry related
• Any other specific pharmaceutical and/or environmental applications