Week 7 — Oct 26: Mid-Term Exam
Mid-term examination covering Weeks 1–6: the opening arc, risk management, and the instrument techniques (NMR; UV-Vis, dissolution and atomic spectroscopy; molecular spectroscopy and solid-state; separations).
**Clear your calendar for this session.** The mid-term is held in the normal class slot.
(Not a lecture.) The mid-term marks the end of the first two movements of the course — the measurement and the rules and the instruments, taught as evidence.
Coverage
| Weeks | Material |
|---|---|
| 1 | The opening arc — analysis as science / STEAM, the molecule-to-market funnel, the ICH framework and compendial methods, clinical development as uncertainty reduction, quality control, automation, knowledge management, cost |
| 2 | Quality risk management — ICH Q9, the risk toolbox, FMEA and RPN, risk assessment → control strategy |
| 3 | NMR — the four observables, qNMR as a primary method, structure elucidation, the heparin case, interpretation as craft |
| 4 | UV-Vis & Beer’s law and its deviations; dissolution and the bioavailability question; atomic spectroscopy and elemental impurities under Q3D |
| 5 | Molecular spectroscopy — IR/Raman/NIR/fluorescence — and the solid-state toolbox (XRPD, DSC, TGA, DVS) |
| 6 | Separation methods — chromatographic theory, van Deemter, method development, the stability-indicating method, CE, the wet-chemistry workhorses, system suitability |
Format
(Instructor: fill in — number of questions, open/closed book, calculator policy, weighting toward interpretation vs recall, and whether the risk-assessment assignments from Weeks 4–5 are due at the exam.)
What is being tested
Consistent with how the course is taught: not just what each technique measures, but what decision the measurement supports and how you would defend the result — the recurring “For discussion” questions are the best guide to the style of reasoning expected.