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Nitrosamine in sitagliptin medicines

Contamination of medicines by nitrosamines is an issue that is constantly gaining in importance.

Currently, the pharmaceutical giant Merck is confronted with nitrosamine impurities in three of its blockbuster diabetes drugs with the active ingredient sitagliptin. The cause is considered to have been found, and Merck is implementing new quality assurance standards.

Sebastian Schmidtsdorff, deputy head of the Quality Unit at Chromicent and specialist in method development, including nitrosamine detection, gave an in-depth interview to the Chemistry World platform. In addition to questions on risk assessment and the frequency of nitrosamine contamination, the focus is primarily on approaches to solutions. Schmidtsdorff emphasises that this is precisely where Chromicent makes a decisive contribution:

With SFC-MS/MS, Chromicent has developed and made freely available a method that can be used universally for the detection of nitrosamines. Chromicent hopes that the authorities will increasingly take on a leading and coordinating role and make freely available and already validated methods accessible, which would then only have to be transferred or revalidated.

The target is clear: drug safety is patient safety.

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