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Scenario #1

Scenario #1. Swine Flu Manufacturer. You are an analytical chemist working in R&D for a large pharmaceutical company which is manufacturing a swine flu vaccine. The pressure to bring this product to market is intense. The first production batches have been made.

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Scenario #1

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  1. Scenario #1

  2. Swine Flu Manufacturer • You are an analytical chemist working in R&D for a large pharmaceutical company which is manufacturing a swine flu vaccine. The pressure to bring this product to market is intense. • The first production batches have been made. • But first you have to meet the product specifications.

  3. Swine Flu Specifications • Color Colorless • Appearance Free of visible particulate • Assay 5 mg/mL (HPLC) • pH 7.4 • Heavy metals Less than 10 ppm The product passes, except for color – the product has a slight yellow tinge

  4. Disaster! • QC sends it to you to figure it out • They require an answer within 24 hours

  5. What would you do? Instrumentation available to you • Infrared spectrometer with ATR • Mass spectrometer • NMR, 400 MHz • XRF • ICP-OES • Fluorimeter

  6. Considerations • What might be causing the color? • What concentrations should you look for? • Sample prep?

  7. Scenario #2

  8. Industrial Espionage! • You have been hired to perform some clandestine analytical work. • Your task: to determine the components of fireworks made in China so the product can be copied. • You have several products to analyze; you need to determine the explosives, colorants and oxidizers.

  9. What would you do? Instrumentation available to you • UV-visible spectrometer • Infrared spectrometer • Raman spectrometer • GC/MS • Atomic absorption

  10. Considerations • What types of materials do you need to identify? • Do you need quantitation? • Safety

  11. Scenario #3

  12. Patent Infringement • Your patent for a new drug to treat psittacosis has been challenged for infringement. • The challenger believes the actual structure of your drug (an antibiotic) is not what the patent claims it is. • You need to respond within 30 days.

  13. What would you do? Instrumentation available to you • Fluorescence • Mass spec • NMR • Infrared • ICP-MS • X-ray fluorescence • X-ray diffraction

  14. Considerations • What aspects of the structure need to be proved? • How close is close? • Could sample prep affect structure?

  15. Scenario #4

  16. Product Tampering • A consumer has returned a bottle of tablets that were purchased recently that are suspected of having been tampered with. • Your job is to determine whether product tampering is likely.

  17. Product Tampering • The product container • Outer box • Lot number, expiration date? • Any tears, signs of re-glue? • Bottle holding tablets • Has it been opened previously? • Number of tablets present? • The tablets • Size / shape / color? • Markings? • Composition?

  18. What would you do? Instrumentation available to you • Infrared • Raman • ICP-OES • GC/MS • NMR (60 MHz) • X-ray diffraction

  19. Considerations • Sensitivity: How sensitive do you need to be to ensure that no adulteration has occurred? • Quantitation • Comparison to a retain of good product

  20. Scenario #5

  21. Art Authentication • It was only a small garage sale, but you found a heavily damaged painting in a handsome frame. You buy it for the frame. • Once you get it home and inspect it, the painting reminds you of a Van Gogh. • Is it possible????

  22. What Would You Do? • Instrumentation available to you • Infrared • Raman • ICP-OES • GC/MS • XRF

  23. Art Authentication • What can a chemist do to “authenticate” artwork? • What components could you analyze? • How do you get samples for analysis? • Can you perform in situ analysis? Non-destructive analysis? • How deeply into the painting should you go? • Once you get the analysis, what do you do with it?

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