title: Expanding the analytical toolbox for identity testing of pharmaceutical ingredients: Spectroscopic screening of dextrose using portable Raman and near infrared spectrometers.
abstract: In the pharmaceutical industry, dextrose is used as an active ingredient in parenteral solutions and as an inactive ingredient (excipient) in tablets and capsules. In order to address the need for more sophisticated analytical techniques, we report our efforts to develop enhanced identification methods to screen pharmaceutical ingredients at risk for adulteration or substitution using field-deployable spectroscopic screening. In this paper, we report our results for a study designed to evaluate the performance of field-deployable Raman and near infrared (NIR) methods to identify dextrose samples. We report a comparison of the sensitivity of the spectroscopic screening methods against current compendial identification tests that rely largely on a colorimetric assay. Our findings indicate that NIR and Raman spectroscopy are both able to distinguish dextrose by hydration state and from other sugar substitutes with 100% accuracy for all methods tested including spectral correlation based library methods, principal component analysis and classification methods.
authors.affiliation: Division of Pharmaceutical Analysis, Center for Drug Evaluation and Research, US Food and Drug Administration, 645 S. Newstead Ave, Saint Louis, MO 63110, USA.
authors.forename: Hirsch K
authors.initials: HK
authors.lastname: Srivastava
authors.affiliation: Division of Pharmaceutical Analysis, Center for Drug Evaluation and Research, US Food and Drug Administration, 645 S. Newstead Ave, Saint Louis, MO 63110, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Wolfgang
authors.affiliation: Division of Pharmaceutical Analysis, Center for Drug Evaluation and Research, US Food and Drug Administration, 645 S. Newstead Ave, Saint Louis, MO 63110, USA. Electronic address: Jason.Rodriguez@fda.hhs.gov.
authors.forename: Jason D
authors.initials: JD
authors.lastname: Rodriguez
mesh_terms: D000465:Algorithms; D004364:Pharmaceutical Preparations / Q000032:analysis*; D019265:Spectroscopy, Near-Infrared / Q000295:instrumentation*; D013059:Spectrum Analysis, Raman / Q000295:instrumentation*
chemical_list: D004364:Pharmaceutical Preparations
keywords: Adulteration; Excipient screening; Identification tests; Near infrared spectroscopy; Raman spectroscopy