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Assessment of the performance of a handheld Raman device for potential use as a screening tool in evaluating medicines quality.
J Pharm Biomed Anal. 2013 Feb 23; 74:47-55.JP

Abstract

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.

Authors+Show Affiliations

Promoting the Quality of Medicines Program, The United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852, United States. mh@usp.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

23245232

Citation

Hajjou, Mustapha, et al. "Assessment of the Performance of a Handheld Raman Device for Potential Use as a Screening Tool in Evaluating Medicines Quality." Journal of Pharmaceutical and Biomedical Analysis, vol. 74, 2013, pp. 47-55.
Hajjou M, Qin Y, Bradby S, et al. Assessment of the performance of a handheld Raman device for potential use as a screening tool in evaluating medicines quality. J Pharm Biomed Anal. 2013;74:47-55.
Hajjou, M., Qin, Y., Bradby, S., Bempong, D., & Lukulay, P. (2013). Assessment of the performance of a handheld Raman device for potential use as a screening tool in evaluating medicines quality. Journal of Pharmaceutical and Biomedical Analysis, 74, 47-55. https://doi.org/10.1016/j.jpba.2012.09.016
Hajjou M, et al. Assessment of the Performance of a Handheld Raman Device for Potential Use as a Screening Tool in Evaluating Medicines Quality. J Pharm Biomed Anal. 2013 Feb 23;74:47-55. PubMed PMID: 23245232.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Assessment of the performance of a handheld Raman device for potential use as a screening tool in evaluating medicines quality. AU - Hajjou,Mustapha, AU - Qin,Yanyan, AU - Bradby,Sanford, AU - Bempong,Daniel, AU - Lukulay,Patrick, Y1 - 2012/10/23/ PY - 2012/07/17/received PY - 2012/09/10/revised PY - 2012/09/22/accepted PY - 2012/12/19/entrez PY - 2012/12/19/pubmed PY - 2013/9/28/medline SP - 47 EP - 55 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 74 N2 - 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. SN - 1873-264X UR - https://www.unboundmedicine.com/medline/citation/23245232/Assessment_of_the_performance_of_a_handheld_Raman_device_for_potential_use_as_a_screening_tool_in_evaluating_medicines_quality_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(12)00526-2 DB - PRIME DP - Unbound Medicine ER -