Detecting Counterfeit Pharmaceutical Using Handheld Neat-Infrared Spectroscopy

By S. Assi, R. Watt and A. Moffat, The School of Pharmacy, University of London

Pharmaceutical counterfeiting is a critical issue accounting for 10 % of the world market by revenue. The impact of pharmaceutical counterfeiting can be counted in monetary loss, delayed healing, and increased morbidity and mortality. The World Health Organization and national regulatory agencies worldwide attempt to identify and prevent the sale of potentially lethal counterfeits. The problem is complex because of the vast number of pharmaceutical formulations, global manufacturing and buying patterns and the wide variety of counterfeiting techniques.

Handheld NIR instrumentation makes the process of inspection rapid, efficient, and surprisingly, inexpensive. NIR spectrometers can directly analyze a pharmaceutical product without preparation and results can be obtained within five seconds or less. The portability of a handheld instrument allows for efficiency in the screening process.

There are a number of strategies poised to answer the challenge of screening for counterfeits. Authentication using color-changing inks, universal serialization, barcodes and radio-frequency identification tags can verify the supply chain while analytical methods including chromatography, isotopic characterization and optical spectroscopy can confirm the composition