Counterfeit tablet

FIGURE 31 FTMS parent ion mass spectrum of the API in the counterfeit tablet. 

Since the monoisotopic signal is the protonated ion, the elemental composition for the API in the counterfeit tablets was therefore determined as C8lTj502N7S3. A computerized search of The Merck Index using the elemental formula suggested the unknown compound to be Famotidine, an active pharmaceutical ingredient widely used in over-the-counter antiulcerative medicine. 

Confirmative data were obtained by acquiring FTMS and FTMS/MS spectra for a solution made from an authentic commercial product containing Famotidine. Both spectra were identical to those acquired for the counterfeit tablets. 

Recently Eliasson and Matousek [26, 62] demonstrated that SORS can provide a chemical signature of the internal content of opaque plastic containers. This is demonstrated in Fig. 3.11 for aspirin tablets held inside an opaque (white) plastic pharmaceutical bottle (1.3mm thick). The conventional Raman signal is overwhelmed by the Raman component originating from the container wall and is consequently ineffective in determining the contents of the bottle. In contrast, the SORS method using a scaled subtraction of two SORS spectra measured at different spatial offsets yields a clean Raman spectrum of the tablets inside the bottle. SORS has also been used in the detection of counterfeit anti-malarial tablets by Ricci et al. [63] the chemical specificity of Raman spectroscopy readily distinguished between genuine and fake tablets and identified the content of the counterfeit tablets. 

A considerable amount of (unpublished) work has been performed by Ciurczak on counterfeit tablets. Using the same algorithms that have been applied to discriminate between placebos and active products, counterfeit products may be easily identified. The spectral variability stems from different raw materials and manufacturing processes, even though the active may be present at the correct level. 

Figure 14.2b, and, in fact, even to reveal different groups of counterfeit tablets. Obviously, the use of LA is beneficial in this context, as it would allow the analysis of a larger number of samples per day. 

Santamaria-Femandez, R., Heam, R., and Wolff J.C. (2008) Detection of counterfeit tablets of an antiviral drug using measurements by MC-ICP-MS and confirmation by LA-MC-ICP-MS... 

FIGURE 32.4 (See color insert following page 622.) NIR spectra of counterfeit tablets from three different batches containing amphetamine as active ingredient. 

The problem with residual solvents is magnified with counterfeit tablets and eap-sules, which are manufactured under less stringent conditions. This subject is the foeus of attention in the next section of this chapter. 

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