Pharmaceutical service provider from Adlershof Chromicent GmbH offers solution for valsartan problems: Simultaneous detection of nitrosamines and other sartan-related impurities in active pharmaceutical ingredients by supercritical fluid chromatography

20. June 2019

Pharmaceutical service provider from Adlershof Chromicent GmbH offers solution for valsartan problems

Simultaneous detection of nitrosamines and other sartan-related impurities in active pharmaceutical ingredients by supercritical fluid chromatography

Chromicent Chromatografiesystem, Bild: © WISTA

Chromatografiesystem, mit dem Arzneimittel auf Gehalt und Reinheit untersucht werden. Bild: © WISTA

Since July 2018, the pharmacological class of “sartans” has been the subject of considerable media and analytical interest, as it became known that they are contaminated with nitrosamines such as N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) and N-nitrosodiisopropylamine (NDiPA). Previous compendial methods are not able to detect these new contaminants. Using the latest and innovative Quality-by-Design (QbD) approach, it has now been possible to develop an analytical method that enables to investigate sartans, such as valsartan and losartan. Also a large class of different nitrosamines in the ppb range and sartan-related impurities can thus be determined simultaneously in a single analysis using supercritical fluid chromatography (SFC). By using SFC, a broad spectrum of nonpolar and very polar impurities can be separated and analyzed in under 20 min. The analytical method developed is validated for limit testing according to ICH Q2(R1) and fulfills default thresholds of EMA and FDA for testing of drug substances and genotoxic impurities. Additionally, it can also be adapted to other pharmaceuticals that may be contaminated with nitrosamines, since tetrazole synthesis as the underlying cause of nitrosamine contamination is important for a set of other non-sartan drug substances.

Abstract in Journal of Pharmaceutical and Biomedical Analysis

 

 

Contact:

Katharina Schuhen
Chromicent GmbH
Johann-Hittorf-Strasse 8
12489 Berlin Adlershof
Germany
+49 (0)30 2332 89300
katharina.schuhen@chromicent.de
www.chromicent.de

 

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