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USP evaluates the Thermo Fisher Scientific TruScan
The US. Pharmacopeial Convention (USP) has given a tentative thumbs-up to Thermo Fisher Scientific’s handheld device for detecting counterfeit medications. USP’s Promoting the Quality of Medicines program (PQM) tested the device, called TruScan RM, for its ability to differentiate among antimalarial drug products with different active pharmaceutical ingredients (API), different brands of the same API, and drug products having the same active ingredient but of different strengths.
The study, published last month in the Journal of Pharmaceutical and Biomedical Analysis, found that the device may perform well in detecting counterfeits, but that it’s not suited to identifying substandard medicines.
Specifically, results showed that the TruScan successfully differentiated APIs, which USP says would be useful in testing counterfeit products containing the wrong API. However, in the comparison with different lots of the same product and the comparison with similar products from different manufacturers, the device could not sufficiently discriminate among the products.
Even so, these results are notable because, as lead study author Mustapha Hajjou, PhD, points out, handheld devices likeTruScan could be much simpler to use than other established counterfeit detecting methods, such as thin layer chromatography, which require specific training and the use of chemicals. TruScan, on the other hand, uses laser-based Raman spectroscopy to detect differences in vibrational frequencies of one API entity versus another.
Aaron Kellogg, a spokesperson for Thermo Fisher Scientific (Waltham, MA), says the main takeaway from the USP report is that TruScan is a powerful tool both in counterfeit and substandard detection, but that it was designed to supplement the lab testing process. “It’s clear that standard lab testing holds value in the substandard identification process.”
Kellogg says the company continues to see strong demand for the product both in the US and abroad among regulatory enforcement agencies and global pharmaceutical companies. The latter, he says, use it for counterfeit screening in field inspections, as well as central forensic laboratory testing.
FDA released its own handheld Raman scanner, dubbed Counterfeit Detection Device #3 (CD3), last year. Kellogg says since handheld Raman instruments are breaking down barriers in counterfeit detection, it’s only natural to see an outgrowth of this technology.