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Technology Palynology
 
Protection strategy Product authentication
Type Analytical technique
System Laboratory based
Medium Medicine
Authentication/Identificaton Authentication
Traceability No*
Cost Price on request
Required equipment Microscope,
reactants for the sample preparation
Vertification level Laboratories
N.B. Palynological analysis is undertaken and identification of palynomorphs made by comparison with reference slides and published pollen databases. Most palynomorphs recovered are anemophilous allowing comparison with published annual and seasonal air-borne pollen data from countries or areas of interest. There is pollen evidence that the production environment is becoming more sanitized as production of counterfeit pharmaceuticals becomes more sophisticated. However, combined with XRD and stable isotope analyses, palynology can provide strong evidence, but not proof, of the source or sources of manufacture of counterfeit pharmaceuticals . These analyses are carried out independently of all other laboratory in the network to avoid unintentional bias in the interpretation of the results obtained.
Description Pollen, spores, fungal hyphae, insects, fibers, charcoal, leaf cuticles, other plant and animal cells and other contaminants are incorporated into genuine and counterfeit pharmaceuticals during production, and can be used as a tool for obtaining forensic clues about their geographical origin. Such contamination can be obtained from the site of manufacture, the source of individual ingredients or both, and only the most highly processed foods or pharmaceuticals lack contaminants.
Tablet samples are processed (a specific sample preparation is needed, example of protocol: http://www.plosmedicine.org/article/fetchSingleRepresentation.action?uri=info:doi/10.1371/journal.pmed.0050032.sd004). The slides are examined with a microscope, pollens are identified by comparison with reference material. These results should be interpreted with caution as the spore and pollen content could be indicative of either the place of manufacture, the source of the individual ingredients, or both, and be influenced by their wide wind dispersal and seasonality. Invertebrate remains and other organic materials embedded in the tablets can also be identified.
 
Strengths * Profiling (provide strong evidence of determination of the source of manufacture);
 
Limitations Destructive;
Large numbers of tablets are required to recover a diverse range of palynomorphs;
Interaction between some excipients and chemicals used for pollen extraction;
Sample preparation complex (needs specific solvents and several steps);
 
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