RAMAN SUPPLEMENT Formulation SVM, correlation Genuine


Suspect product


SV


Product family


Correlation test


API peak detection Counterfeit FIGURE 3 Proposed method based on Raman spectroscopy and SVM for the quick detection of medicine counterfeits


spectrum and its comparison with API and excipients databases. An example of visual analysis is provided in Figure 4. The main components of two counterfeits coming from the same seizure have been determined by spectral comparison with the excipients’


detected, its chemical composition has to be determined in order to evaluate the hazard the patients are exposed to”


“Once a counterfeit has been


database. No API was observed. The result of the analysis implies that the first counterfeit is mostly made of lactose while the profile of the second shows corn starch. Other minor components were also


FIGURE 4Raman spectra of two counterfeit capsules coming from the same seizure. The first one is mostly composed of lactose while the second capsule mainly contains starch


acceptance tests are applied to determine if it is a genuine medicine or a counterfeit. The first test consists of a correlation with the database references. If the correlation is below a given threshold, the suspect product is declared counterfeit. If it is above it, an API peak test is performed. All the peaks of the API have to be detected in the suspect product so that it is declared genuine. If only one misses, the product is considered as counterfeit.


Determination of the chemical composition of counterfeits Once a counterfeit has been detected, its chemical composition has to be determined in order to evaluate the hazard the patients are exposed to. This represents the second step of analysis of counterfeits by Raman as suggested in Figure 1 on page 4. Due to its chemical selectivity, Raman


spectroscopy enables the analysis of the content of a specimen by single interpretation of its


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European Pharmaceutical Review Volume 16 | Issue 5 | 2011


observed by Raman spectroscopy in the previous counterfeits, such as sibutramine for both and taurine for the second (Figure 5). In the


FIGURE 5 Raman spectra of the previous counterfeits (Figure 4) compared with sibutramine and taurine references. Sibutramine is detected in the first profile while only in traces in the second. The second counterfeit also presents peaks of taurine


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