Counterfeit drugs identification

Technology—involve pharmaceutical companies and distributors to develop innovative solutions, such as radiofrequency identification (RFID) to track movements of drugs, tamper-proof packaging to deter tampering, and printing technologies aimed at end user compliance Risk communication—IMPACT to develop and coordinate effective mechanisms to alert and respond to counterfeit drug activities inform and educate users and healthcare professionals to be alert and report suspicious cases... 

A case study of the identification of a counterfeit drug molecule is discussed in Section IX. C. This is a step-by-step discussion of the experimental procedure using FTMS to address this important issue. After the exact mass of the unknown componnd has been determined, the next step is to derive its elemental composition. The minimnm and maximum number of expected atoms present in the componnd mnst be specified in the search criteria to allow the compnter program to calculate possible elemental compositions. A nniqne fit of only one elemental composition is rarely obtained. The nnmber of possible compositions increases with the increasing nnmber of elements present and with increasing mass. However, other information, snch as the number of double bond eqnivalency and the isotopic distribution of the parent ion mass spectrnm, can be used to reduce the possible elemental compositions to a reasonable nnmber. Fnrther discussion can be fonnd in Section IX. C. 

Scafi, S.H. and Pasquini, C. (2001) Identification of counterfeit drugs using near-infrared spectroscopy Analyst 126, 2218-2224. 

Many drug products look similar hence color in combination with shape and/or an embossed or printed logo can help with identification. Also, this combination can assist in the prevention of counterfeiting. 

The main use of TLC in analysis of amoxicillin and its formulated products is as an identity test. A major study [105] using silica gel and silanised silica gel plates with thirty five different mobile phases and iodine vapour detection produced a system, on silanised plates with ammonium acetate/acetone mobile phase, in which amoxicillin was separated from all the other penicillins studied. A slightly modified version of this system was subsequently introduced into the European and British Pharmacopoeia monographs for amoxicillin trihydrate and sodium salt [2]. The British [57,58] and US [9] Pharmacopoeias specify other TLC systems for identification of amoxicillin in formulated products. Simple TLC methods have been developed for identification of several compounds on the WHO essential drugs list, to help combat counterfeiting [106]. For amoxicillin, systems using ethyl acetate/acetic acid/water or acetone/toluene/acetic acid/water with silica gel plates were recommended. 

Jasper et al. [44] address the potential for the use of EA-IRMS to characterize conunerdally available analgesic drugs as they leave the manufacturer for distribution. These data could be used to assist in the differentiation of production batches and assist in the identification of counterfeit materials on the market. Jasper et al. [45] reported on the analysis of the isotopic compositions of four different active pharmaceutical ingredients (APIs) from different manufacturers and different batches. Samples from different sources (manufacturers and/or batches) could be readily differentiated using EA-IRMS. Phillips et al. [23] also reported on research conducted by Jasper on differentiating pharmaceutical products from different batches using EA-IRMS. 

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