Quality control of cytotoxic drug preparations by means of Raman spectroscopy.
Institute for Clinical Chemistry and Laboratory Medicine, Jena University Hospital, Jena, Germany.Pharmazie (Impact Factor: 1.05). 01/2012; 67(1):95-6.
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- "Raman spectroscopy has many strengths, since it is a faster analytical method that can ensure operator safety and that doesn't require important technical skills (Bourget et al., 2014a, 2014b, 2013, 2012; Buckley and Matousek, 2011; Kiehntopf et al., 2012). "
ABSTRACT: In France, chemotherapy preparation units of hospital pharmacy compound cytotoxic infusion bags adapted to each patient. The narrow therapeutic index of these preparations led us to implement qualitative and quantitative control for patients' safety. To this aim, we calibrated an equipment combining UV-visible spectrometry and Raman spectroscopy (QC Prep + ®) and monitored 14 different molecule-solvent combinations over a 18 months period. This rapid and specific method allowed the qualitative and quantitative analysis of 1 mL sample tests in less than 2 minutes. On 5742 anticancer preparations, we obtained accepted results with more than 99.4% solvent identification, 99.6% drug identification and only 1.52% of preparations not matching quantitative specifications (+/− 15% of theoretical concentration). This quantitative control enabled us to pinpoint some critical points of production for two of the most common preparations. We thus updated the procedures of reconstitution and preparation, increasing the quality of final product. UV-Raman spectrometry is thus an effective tool to control chemotherapy infusions and to improve good practices of preparation.
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