Historically, FDA surveillance of pharmaceutical products and ingredients has involved sampling, sending to a laboratory, and waiting for results from extensive testing such as that in the United States Pharmacopeia. An ever increasing percentage of products and ingredients are now coming from overseas, potentially increasing consumer exposure to poor quality, counterfeit and adulterated pharmaceutical products. In response to this situation, the FDA has developed rapid and portable screening methods to assess the quality and safety of pharmaceutical products at ports of entry.   This presentation will briefly describe the current spectroscopic methods being utilized by the FDA for field surveillance of pharmaceutical products including Raman, near infrared (NIR), x-ray fluorescence (XRF) and ion mobility (IMS) spectrometries,.  Experiences with method development, chemometric data analysis, and field deployment will be discussed.

Rapid screening methods for pharmaceutical surveillance

244th National Meeting (2012)

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