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.

Identification of lactic acid bacteria and rhizobacteria by ultraviolet-visible-near infrared spectroscopy and multivariate classification

“…These bands are attributed to the first overtone of O-H stretch and could be related to the dextrose present in Bennett agar. 36 However, several absorption bands appear specifically for LAB and for single strains of Arthrobacter, Microbacterium, and Pseudomonas.…”

The feasibility of Raman spectroscopy for accurate assessment of essential criteria in pharmaceutical industry by investigation of Metformin hydrochloride tableting process

“…12 Over the past decade, the use of Raman spectroscopy has emerged in pharmaceutical manufacturing industry for characterization of different phases of raw materials, investigation of the chemical composition of a sample, homogeneity of the constituent in the formulations, and the interaction of active substances and excipients. 2,4,5,[10][11][12][13]20,[24][25][26][27][28][29] Raman spectroscopy based on light-mater interactions measures the inelastic light scattering of constantly vibrational, rotational, and other low-frequency intramolecular bonds. 14 In this process, incident photons may lose or gain energy, and the loss of incident photon energy is a much stronger probability and is termed Stokes scattering-the reverse state, in which the incident photons gain energy, is known as anti-Stokes scattering.…”

“…Meanwhile, the sensitivity and performance of portable Raman spectrometers have progressed to the point that they can be directly used in pharmaceutical industry in the field of real-time testing of samples. 1,[27][28][29]34,35 Regarding to overall goal of rapid analysis, in this study, attempts were made to investigate the feasibility of using portable Raman spectrometer for on-line and off-line applications. For this aim, the precision and accuracy of constructed data from a portable Raman system were inspected.…”

“…Therefore, there is generally no technical difficulty in the case of Raman spectroscopy and the collected light is easily dispersed onto a detector 12 . Over the past decade, the use of Raman spectroscopy has emerged in pharmaceutical manufacturing industry for characterization of different phases of raw materials, investigation of the chemical composition of a sample, homogeneity of the constituent in the formulations, and the interaction of active substances and excipients 2,4,5,10–13,20,24–29 …”

Discrimination of Substandard and Falsified Formulations from Genuine Pharmaceuticals Using NIR Spectra and Machine Learning

“…The complexity often associated with pharmaceutical products has been a major challenge toward building a robust model for point of use technology in global assessment of SFPs. NIR is attractive for applications in pharmaceutical and medical fields because it is nondestructive, requires little to no sample preparation, and is very fast to operate . Pasquini and Roggo et al recognized the unique ability of NIR to give useful information about complex samples including petroleum oil, wood, polymers, and pharmaceuticals. − This information ranges from classification, authentication, or identification to quantification of target analytes in complex matrices …”