Detection of unknown impurities in medicinal products

The discovery and identification of unexpected impurities in pharmaceuticals has become the focus of public interest in recent years, especially since the „valsartan case“ became known. Various working groups have set themselves the task of developing intelligent analysis strategies which can be used to uncover unknown and, above all, unexpected impurities. The research activities in this field have already become a certain priority topic of FFQM, the Frankfurt Foundation Quality of Medicine.

The research project „SFC-based purity method development for the enantioselective separation of mepromazine and dapoxetine and their impurities“ funded by FFQM has been initiated by Professor Dr. Ulrike Garscha, Institute of Pharmacy at the University of Greifswald, and should be realised as part of two diploma theses.

SFC (Supercritical Fluid Chromatography) offers certain advantages over HPLC, especially for the analysis of lipophilic and chiral compounds. Improved resolution can be achieved with faster analysis times and the range of applications is wide. Added to this are environmental friendliness and easier compatibility with mass spectrometry. Within the scope of preliminary work already carried out, an improved resolution of the enantiomers as well as a simultaneous detection of related known and unknown substances could be confirmed in comparison to published HPLC or capillary electrophoresis procedures. By coupling the SFC to a mass detector, an attempt will also be made to identify the unknown contaminants.