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Rockville, MD, United States

Hajjou M.,The United States Pharmacopeial Convention | Qin Y.,The United States Pharmacopeial Convention | Qin Y.,U.S. Food and Drug Administration | Bradby S.,The United States Pharmacopeial Convention | And 2 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2013

The TruScan® handheld Raman device is used for testing finished pharmaceutical products in the field to detect counterfeit and substandard medicines. Present work reports on the device's ability to discriminate between a specific product and similar products from different manufacturers, unrelated medicines, and medicines with different strengths. This investigation evaluated its ability to differentiate between similar drug products of similar or different strengths, focusing on the specificity and precision of the testing. First, several units of the same medicine's dosage form were compared; then comparisons were made between unrelated products, similar products, and products with different strengths. The six pharmaceutical products used in testing were from commonly used analgesic, antimalarial, and antidiarrheal medicines. The results showed that the performance of the TruScan® device depends on the nature and the strength of the dosage form tested; while the device could be suitable for authentication of some finished pharmaceutical products and, hence, could be used to detect some counterfeit medicines, it could not be used to detect substandard medicines. Careful consideration should be given when using the device as a screening tool for counterfeit medicines. © 2012 Elsevier B.V.

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