Abstract - Pharmaceutical products often contain volatile organic compounds (VOCs), which are made up of residual solvents from the manufacturing process and of flavoring additives. These substances may form a "signature" that perhaps could be used to reveal the product source. To study this possibility, a new method for detecting and quantitating VOCs in pharmaceutical preparations is described. It is based on extraction of the dry powder by the full evaporation technique, separation of the VOCs by gas chromatography in a capillary with an apolar stationary phase, and exposure of the compounds by ion-trap detection with the apparatus run in the full-scan mode. The search of some drug substances or pharmaceutical products for VOCs revealed ethanol, acetone, 2-propanol, methyl acetate, toluene, eucalyptol, and menthol, whose concentrations were in the range 0.008-26 mmol/kg of sample. The within-day or between-day precision studies showed, except for methyl acetate, a relative standard deviation less than 13%. The concentrations for the different compounds were at the limit of detection or of quantification in the range 0.4-4, respectively, 1-10 µmol/kg of sample. Based on the quantitative data, distinct signatures were obtained from synonymous medicines made by four diverse producers. These data indicated that the method provides a means for disclosing the origin of a drug product.
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