scenario #1

Scenario #1

Swine Flu ManufacturerYou 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.

Swine Flu SpecificationsColor ColorlessAppearance Free of visible

particulateAssay 5 mg/mL (HPLC)pH 7.4Heavy metals Less than 10 ppm

The product passes, except for color – the product has a slight yellow tinge

Disaster!QC sends it to you to figure it out

They require an answer within 24 hours

What would you do?Instrumentation available to you

Infrared spectrometer with ATRMass spectrometerNMR, 400 MHzXRFICP-OESFluorimeter

Considerations

What might be causing the color?What concentrations should you look for?Sample prep?

Scenario #2

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.

What would you do?Instrumentation available to you

UV-visible spectrometerInfrared spectrometerRaman spectrometerGC/MSAtomic absorption

ConsiderationsWhat types of materials do you need to identify?Do you need quantitation?Safety

Scenario #3

Patent InfringementYour 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.

What would you do?Instrumentation available to you

Fluorescence Mass specNMRInfraredICP-MSX-ray fluorescenceX-ray diffraction

ConsiderationsWhat aspects of the structure need to be proved?How close is close?Could sample prep affect structure?

Scenario #4

Product TamperingA 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.

Product TamperingThe 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 tabletsSize / shape / color?Markings?Composition?

What would you do?Instrumentation available to you

InfraredRamanICP-OESGC/MSNMR (60 MHz)X-ray diffraction

ConsiderationsSensitivity: How sensitive do you need to be to ensure that no adulteration has occurred?QuantitationComparison to a retain of good product

Scenario #5

Art AuthenticationIt 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????

What Would You Do?Instrumentation available to you

InfraredRamanICP-OESGC/MSXRF

Art AuthenticationWhat 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?