Quantification of impurities and excipients

We have elaborate experience in the quantification of drug substances in complex matrices. This experience is put into practice when developing and validating robust quantitative methods in the pharmaceutical context.

We have over 20 years of experience in developing and validating quantitative LC-MS/MS based methods for GLP-conform bioanalytical studies. Our mass spectrometry specialists use this experience for equivalent studies under GMP. We are able to develop quantitative methods for the most difficult of compounds. For some we have established validated methods, e.g. for the quantification of different polymers (PPG, PEG, poloxamines). Furthermore, we are also applying mass spectrometry based methods to sensitively quantify potentially genotoxic- and genotoxic impurities. Capitalise on our know-how and generic methods for your:

  • In-process controls
  • Samples from cleaning validation
  • Tests for poteintially genotoxic or genotoxic impurities
Quantifizierung von Verunreinigungen oder Hilfsstoffen