Pharmaceutical Analysis

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The accuracy of prediction models based on spectroscopic measurements can be influenced by a variety of factors, including aging equipment. Continuous monitoring is key to managing the PAT model lifecycle and ensuring that changes over time do not negatively affect prediction model performance.

In this review, we show a wide range of examples of the expanding use of multivariate analysis (MVA) in pharmaceutical manufacturing and control. MVA is being used to resolve numerous analytical challenges, such as overcoming matrix effects, extracting reliable data from dynamic matrices, and more.

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These tables are supplementary to the “Atomic Perspectives” column installment “Using XRF as an Alternative Technique to Plasma Spectrochemistry for the New USP and ICH Directives on Elemental Impurities in Pharmaceutical Materials,” which was published in the July 2017 issue of Spectroscopy (1).

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Because of the wide variety of ways counter drugs have been entering the pharmaceutical supply chain, there is an imminent need for quick and inexpensive methods to identify drug components and quantify active ingredients. Here, we report results illustrating the screening properties of solvent assisted ionization mass spectrometry (SAI-MS) and the quantitative properties of liquid chromatography (LC)-SAI-MS. These methods offer high sensitivity, versatility, and in combination, rapid turnaround time. Suspect samples of fexofenadine hydrochloride and hydroxychloroquine were rapidly screened and compared to their legal counterparts using SAI-MS.