Pharmaceutical Analysis

An evaluation of the ability of XRF spectrometry to perform elemental impurity analysis of 12 elements in various pharmaceutical materials

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).

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.

This article covers the changes so far to United States Pharmacopeia (USP) chapters <232> and <233>, the International Conference on Harmonisation (ICH), the European Medicines Agency (EMA), and the European Pharmacopoeia (EP), impending changes, and options for preparing for those changes.

Bernhard Lendl and Cosima Koch of the Vienna University of Technology have developed a new method for on-line monitoring of fermentations using mid-infrared spectroscopy.

The authors discuss the use of vibrational spectroscopy to differentiate an authentic article from a counterfeit one throughout a product's lifecycle, from component receipt at the site of manufacture, to product receipt by the end user.

The authors discuss the use of FT-NIR to identify several different types of drug formulations.

In this article, the authors take a look at the identification, synthesis, and characterization of impurities in Ramipril tablets.

This article describes the ability to increase the sensitivity for a target compound in the presence of high-level background impurities by removing the dosing vehicle using a high-field asymmetric waveform ion mobility spectrometry gas-phase separation before mass spectrometry analysis.

The element selenium plays three distinct roles in biological processes, functioning in turn as a toxicant, a chemopreventive agent, and a heavy metal antagonist. This article discusses current research associated with each role, and how ICP-MS can be employed to better understand and utilize selenium's properties.