EMA – Statement Nitrosamine

The EMA has published a final statement on nitrosamine impurities in medicinal products. The full report can be found *here*.

The publication of Chromicent is also mentioned:

“A rather new approach has been published in May 2019 describing the simultaneous determination of related substances and N-nitrosamines in valsartan and losartan [Schmidtsdorff, Schmidt (2019)] in one chromatographic run only using supercritical fluid chromatography (SFC) with modifier (methanol and formic acid), combined with UV and electrospray ionisation (ESI) MS detection. This may have some advantages for routine control of N-nitrosamine.”

We are pleased to announce that we have further developed the method and are currently testing for 14 nitrosamines in all kinds of drug products, excipients, API’s and formulations independent from the sartans. A follow-up publication is in preparation, we are keeping you up to date.