Raman Spectral Library for Counterfeit Detection

18th March 2015 | 9PM ET / 1AM GMT / 2AM CET / 9AM SGT | Dr. Jason Rodriguez, FDA Division of Pharmaceutical Analysis (DPA) and Dr. Katherine A. Bakeev, Director of Analytical Services and Support for B&W Tek |WATCH FOR FREE

The global supply chain of medicines is vulnerable to adulteration and introduction of counterfeit products. According to the World Health Organization, counterfeit drug products may contain less active pharmaceutical ingredient (API) than the amount listed on the packaging (sub-standard), no API, or be altered in some other way. The US. FDA’s Division of Pharmaceutical Analysis (DPA) is developing field-deployable, rapid spectroscopic screening methods for a wide range of APIs, excipients, and finished drug products. This is a major shift from traditional laboratory-based methods, which rely primarily on chromatographic testing to determine drug content and assay. Chromatography usually requires transport of the sample to a dedicated laboratory, increasing cost and time for analysis and greatly limiting the number of samples that can be analysed. The rapid screening Raman methods presented typically require less than a minute per sample, are non-destructive towards the sample, and may be performed in the field using portable/handheld Raman instruments. The Raman methods use a spectral library-based approach to make a qualitative assessment that is based on spectral correlation (SC) values. The Raman spectral correlation methods are useful for initial screening to identify samples that require further screening in the laboratory, thereby allowing a dramatic increase in the number of samples analysed without a dramatic increase in personnel. These methods compare Raman spectra of samples to known reference spectra from the library. The reference library spectra are acquired on a laboratory-grade Raman instrument, and the entire library is distributed to field-deployable, handheld Raman spectrometers. The DPA spectral library contains over 550 entries, spanning APIs, excipients, and finished products. The method presented can be used to screen drugs in mail facilities, at manufacturing sites, at point of use or in stockpiles during crisis situations. Here we evaluate the Raman spectral library of finished products, with an emphasis on method specificity and counterfeit identification, and demonstrate use on a handheld instrument.


2_RodriguezDr. Jason Rodriguez, from the FDA, received his Ph.D. from the University of Illinois at Urbana-Champaign in 2009 and his B.S. in chemistry from the University of Texas Pan American in 2004. He joined the FDA/DPA in 2009 and has worked on developing field-deployable Raman and near infrared spectral library methods.





Sponsored by B&W Tek








B&W Tek is an advanced instrumentation company producing optical spectroscopy, laser instrumentation and laboratory, portable and handheld Raman systems. B&W Tek has a long history of providing spectroscopy and laser solutions for the pharmaceutical, nutraceutical, biomedical, physical, chemical and materials science communities


katherineb2Dr. Katherine A. Bakeev is the Director of Analytical Services and Support for B&W Tek in Delaware. Prior to joining B&W Tek she was the Chief Scientist for CAMO Software Inc. and has many years of industrial experience in the electronics, chemical and pharmacyutical industries. From 2005-2009, she worked in the Process Analytical Technology and Chemometrics group of GlaxoSmithKline. Her work experience has included supporting customers in pharmaceutical and chemical industries as a product specialist for Foss NIRSystems and work in process analytical chemistry to enhance process understanding with specialty chemical manufacturer, International Specialty Products (ISP), and as a development engineer in the Materials Science and Engineering department of AMP Incorporated. Katherine earned her PhD in Polymer Science and Engineering from the University of Massachusetts in Amherst, and has a Masters in Technology Management from Stevens Institute of Technology, in addition to her BS from Case Western Reserve University. She is the editor of the book Process Analytical Technology: Spectroscopic Tools and Implementation Strateg
ies for the Chemical and Pharmaceutical Industries, now in its second edition. She has been a member of the Society of Applied Spectroscopy (SAS) since 1993, serving as the national secretary of the organization in 2010-2011. She has served on the publication and nominating committees, and serves on the Editorial Board of the journal Applied Spectroscopy.

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