Colleagues Jeremy Peters, Brittany Handzo, Shan Xiao, PhD and Ravi Kalyanaraman, PhD from the Forensics and Innovative Technologies (FIT) group within Global Quality Analytical Science and Technology (GQAS&T) at Bristol-Myers Squibb, present two methods of counterfeit drug determination.
PROTECTING pharmaceutical products from counterfeiting is not only vital for any pharmaceutical company to ensure brand protection but, more importantly, to ensure the health and safety of patients.1 Several laboratories across the globe use benchtop and portable spectroscopy instruments to screen pharmaceutical counterfeits2 and one effective way to authenticate and verify the identity of pharmaceutical products is by Raman spectroscopy. Typically, a high-quality Raman spectral ‘fingerprint’ is collected for an authentic drug product. This fingerprint can then be added to a spectral library and used to screen potential suspect product. By comparing the measured Raman spectra of suspect products against the spectra of the authentic samples, counterfeit determinations can be made.3 This process is considered a simple identity testing technique. The United States Pharmacopeia (USP) compendial guideline for submitting monographs for pharmaceutical products requires more than one orthogonal method for identification testing.4,5 Therefore, in this article, we present the results from both Raman spectroscopy and hyperspectral imaging (HSI) in the visible near-infrared (VNIR, 400-1,000nm) region to correctly identify and classify four different types of counterfeits of a given branded drug product. The VNIR technique provides complementary results to Raman spectral results and confirms the classification of the counterfeits.
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