Abstract
The aim of this study was to learn to what extent the selected instrumental techniques, differential scanning calorimetry (DSC), as well as Fourier-transform infrared (FTIR) and Raman spectroscopies, can be used to detect both organic or inorganic magnesium compounds in the dietary supplements and medicinal products. Besides magnesium compounds as the active pharmaceutical ingredients (APIs), the preparations contain also other organic and inorganic APIs and several excipients. The study will be extended over the analysis of the products manufactured by various firms but containing the same API at different levels. In this way, it will be possible to assess the impact of excipients on the DSC scans and the FTIR and Raman spectra of a dominant constituent present in a studied preparation. The study on thirty commercially available dietary supplements and medicinal products has shown that in the majority of cases the DSC, FTIR and Raman techniques could be used for the detection of APIs in these commercial products. This was possible with the aid of the endothermic DSC peaks and the so-called matching factors of the FTIR and Raman spectra to those of substances used as standards. Both the complex composition and low levels of API in the studied preparations have been identified as the factors which have a strong impact on the usefulness of the three techniques for the detection of APIs in the dietary and medicinal products.
Highlights
Quality evaluation of dietary supplements and medicinal products is mandatory from the point of view of efficacy, safety and stability of these preparations used for prophylactic and therapeutic purposes
The aim of this study was to learn to what extent the selected instrumental techniques, differential scanning calorimetry (DSC), as well as Fourier-transform infrared (FTIR) and Raman spectroscopies, can be used to detect both organic or inorganic magnesium compounds in the dietary supplements and medicinal products
This was possible with the aid of the endothermic DSC peaks and the so-called matching factors of the FTIR and Raman spectra to those of substances used as standards
Summary
Quality evaluation of dietary supplements and medicinal products is mandatory from the point of view of efficacy, safety and stability of these preparations used for prophylactic and therapeutic purposes. Pharmaceutical law requires controlling compatibility of active pharmaceutical ingredients (APIs) and excipients with the appropriate standards [1, 2]. This obliges the producers to control the quality of all raw materials used in the manufacturing of medicinal products and to screen this process. In recent years there are legislation works conducted on the regulations, according to which the process of registration, manufacturing and quality control of dietary supplements should obey the same rules, as those referring to pharmaceuticals
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