06. October 2017

Spectrochemical elemental analysis of pharmaceuticals and raw materials used for their production will be in the nearest future an obligatory part of quality and safety control for compliance with new standards announced by the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Q3D). The present paper surveys R&D articles and scientific papers devoted to determination of the elemental impurities by inductively coupled...

26. January 2017

Abstract The interest of consumers and government organizations on improving the quality of food and its impact on human health is growing in recent years. Consuming low-calorie foodstuffs are increasingly demanded, and the presence of artificial sweeteners plays an important role not only in food but also in waste reaching the environment. Analysis of these compounds is important in assessing food safety and quality. This chapter reviews the analytical approaches for the extraction and...

22. March 2016

A number of intravenous immunoglobulin preparations are stabilized with sugar additives that may lead over time to undesirable glycation reactions especially in liquid formulation. This study aimed to evaluate the reactivity of sugar excipients on such preparations in condition of temperature, formulation and concentration commonly used for pharmaceutical products. Through an innovative LC-MS method reported to characterize post-translational modifications of IgGs Fc/2 fragments, a stability...

29. November 2015

Counterfeit drugs are a major threat to public health. Current efforts focus on serialization of the secondary packaging which do not allow to trace the individual unit. As a proof of concept, we intended to mark each tablet for its unambiguous recognition. More

24. September 2015