Gerd Vanhoenacker | Authors


Determination of Genotoxic Impurities in Pharmaceuticals

The determination of genotoxic impurities (GIs) in drug substances and pharmaceutical products is an emerging topic in pharmaceutical quality control. GIs are intermediates or reactants in the synthetic pathway of a drug substance and should be monitored at ppm (?g/g drug substance) or even ppb (ng/g) levels. This is several orders of magnitude lower than in classical impurity analysis (0.05% or 500 ppm level) or in residual solvent analysis. Analytical methods for the determination of GIs include gas chromatography (GC) and liquid chromatography (LC), both often combined with mass spectrometry (MS) detection. Some typical examples of GIs trace analysis using GC and LC are presented. The potential of on-line reaction monitoring is also discussed.

Ultralow Quantification of Pesticides in Baby Food

The safety of the food that our children eat is a global concern. Regulations are in place that limit the maximum level of pesticides that can be present in food meant for children, and methods to detect levels well below those limits are needed to ensure the safety of the food supply. Combining the speed and separation efficiency of ultrahigh-pressure liquid hromatography (UHPLC) with the sensitivity and selectivity of triple-quadrupole mass spectrometry (MS)-MS results in a method that can deliver ultralow quantification of pesticides in baby food, with limits of detection more than an order of magnitude below the allowed maximum levels.

Reversed-Phase HPLC Column at Extreme High Temperature (150°C or Higher)

In general, polymer-based columns have a broad pH range (pH 2 to 13), and some have high temperature tolerance (up to 150°C or higher). Considerably large selectivity changes can be obtained by varying analysis temperature and mobile phase pH. Having control on these two parameters over wide ranges can be especially useful in method development.