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Event Overview:
Globalization of the pharmaceutical supply chain appears to be increasing the risk that pharmaceutical consumers will be exposed to drug products that have been adulterated. Traditional surveillance testing by collecting samples and sending them to labs for analysis is inefficient and time consuming. Higher efficiencies can be achieved by screening pharmaceuticals at site in order to selectively sample and further test suspect materials. Portable spectroscopic instruments are now readily available to support field testing of pharmaceutical materials. Methods developed on these instruments must be rapid and have the sensitivity required to identify contaminants in pharmaceutical materials. They must also have user friendly interfaces, because field analysis is often performed by personnel who are not instrument specialists. Finally, efficient procedures for method distribution must be developed so that calibration models need not be recreated on each individual instrument. This presentation will describe our development of portable Raman spectrometric methods for field analysis of diethylene glycol in glycerin. The measurements are rapid, requiring less than 1 minute per sample, and chemometric methods of analysis provide the sensitivity required to detect diethylene glycol at levels anticipated when adulteration is economically motivated. The calibration transfer procedures utilized to distribute these methods to multiple instruments will also be described, and the sensitivity of the transferred methods will be compared to the sensitivity of methods developed on individual instruments.
Key Learning Objectives:
- Describe the challenges associated with pharmaceutical surveillance using portable, geographically distributed spectrometric instruments.
- Describe why quantitative chemometric models are often necessary for identifying adulterated pharmaceutical materials.
- Describe the advantages of transferring calibration models using standardization procedures rather than developing global calibration models or instrument-specific calibration models.
For questions, contact Jamie Carpenter at jcarpenter@advanstar.com |
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Who Should Attend: |
Spectroscopists developing practical Raman quantitative methods on multiple instruments. Spectroscopists interested in transferring methods between instruments. |
Speakers: |
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John Kauffman
Research Chemist, FDA Division
Pharmaceutical Analysis |
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Connie Ruzicka
Research Chemist, Division of Pharmaceutical Analysis
Food and Drug Administration |
Moderator: |
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Laura Bush
Editorial Director Spectroscopy |
Sponsors: |
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Sponsored by:
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