E-DRUG: Using spectroscopic fingerprints to detect counterfeits
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dear E-druggers,
One of the major problems with addressing the counterfeit drug distribution is a lack of adequate sustainable technologies which can be used to assess whether the right product is present or not.
Fortunately there now are suitable technologies which can be used to obtain the molecular images of formulated products over the full range of molecular absorptions from the UV through the Near Infrared regions. The unprocessed images also carry physical property measures such as apparent particle size through scattering and apparent hardness through reflectivity. Each product from a given company should have a distinct molecular image “fingerprint” which could be used to identify it.
What is needed to implement such a program is for the spectroscopy system and pharmaceutical manufacturers to establish a standard spectroscopic reporting format so the industries can either acquire the data in that format or map their acquisition format into that standard.
Such an effort was undertaken many years ago by the “Joint Committee on Atomic and Molecular Physical” Data Exchange—JCAMP-DX which is now under the auspices of the “International Union of Pure and Applied Chemistry” (IUPAC). Once the standard format is established reputable manufacturers could publish the molecular image databases for their products so criminal investigators and regulatory bodies could readily identify counterfeit pharmaceutical products.
An example of such an undertaking has been published: “Screening for Counterfeit Drugs Using Near-Infrared Spectroscopy” Olsen BA, Borer MW, Perry FM, and Forbes RA, Pharm. Tech. June, 2002, pp 62-71, 95.
Regards,
Tom Layloff, Ph.D.
Senior Quality Assurance Advisor
Supply Chain Management System
USA
tlayloff@aol.com