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New technique improves purity of medicines

Dutch researcher Roelof Mol has investigated possibilities for more accurately determining the composition of medicines. He came up with a combination of two techniques that were previously considered to be incompatible: the separation technique electrokinetic chromatography (EKC) and the detection technique mass spectroscopy (MS). He has used this approach to develop an extra quality control mechanism for the active ingredient and excipients in medicines. With this, the chance of a toxic substance ending up in a medicine will be reduced considerably.

Mol applied the combined technique he has developed to so-called impurity profiling, during which contaminants in pharmaceutical samples are analysed. It proved possible to measure contaminants in medicines to within the 0.1% (m/m) level, which means the method satisfies all of the official sensitivity requirements.

No more harmful side effects

The combined technique can also help to limit the harmful side effects of medicines. Many medicines consist of several forms that are, as it were, mirror images of each other. One of the mirror images is the active ingredient where as the other can cause side effects. The medicine Softenon is a well-known example of this. The active substance is thought to be harmless but the mirror image of this was possibly the cause of serious birth defects.

The standard technique for determining harmful contaminants in medicines is high pressure liquid chromatography (HPLC). Mol believes that his linking of the separation technique EKC to the detection technique MS is a very good alternative analysis technique for checking the composition of medicines. The sensitivity of the systems is good and it can be used for a wide range of medicines. Mol is not alone in his thinking. Two companies participating in the research, Solvay and Organon, have also expressed particular interest in the systems.

Besides decreasing harm to human lives this will also save costs. In 2006, for example, a side effect of a medicine was reported on more than 6000 occasions - estimated costs for hospital admission: 85 million euros.


Contact: Roelof Mol
Netherlands Organization for Scientific Research

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