Promoting the Quality of Medicines Program, The United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852, United States.
J Pharm Biomed Anal. 2013 Feb 23;74:47-55. doi: 10.1016/j.jpba.2012.09.016. Epub 2012 Oct 23.
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.
TruScan(®)手持式拉曼设备用于在现场测试成品药物，以检测假药和劣药。目前的工作报告了该设备区分特定产品和来自不同制造商、无关药物以及不同强度药物的能力。本研究评估了它区分类似或不同强度的类似药物产品的能力，重点是测试的特异性和精度。首先，比较了同一药物剂型的几个单位；然后对无关产品、类似产品和不同强度的产品进行了比较。用于测试的六种药物产品来自常用的镇痛药、抗疟药和止泻药。结果表明，TruScan(®)设备的性能取决于所测试剂型的性质和强度；虽然该设备可适用于某些成品药物的认证，因此可用于检测一些假药，但不能用于检测劣药。在将该设备用作假药筛查工具时，应谨慎考虑。
