impurity testing / trace analyses

We are specialised in several topics related to impurity testing and trace analysis.

related substances
  • Stability-indicating purity testing of APIs and drug products
  • Forced-degradation studies for evaluation of degradation pathways and mechanisms
  • Documentation of stability-indicating method properties using peak purity evaluation
  • Differentiation between degradation products and synthesis by-products
extractables / leachables

Testing of plastic primary packaging materials of drug substances and drug products is increasingly requested by the regulatory authorities. We set up these studies and generate the necessary results for your marketing authorisation application, variations procedure or certification. We offer you

  • Exploratory testing for profiling of potential extractables of various primary packaging materials, including complete identification and toxicological qualification of extractables, if required
  • Confirmatory migration studies within the scope of ICH stability studies and in-use stability studies
  • Regulatory support including setting of specifications as well as filing of justification of specifications, expert reports and counseling
  • Matrix specific method development and validation
genotoxic impurities

We have extensive experience in determination of genotoxic impurities. We develop individual methods for these determinations with the required working range in the ppm- and ppb-range, mainly using GC-MS or LC-MS.

testing for residual solvents

We conduct testing for residual solvents according to the pharmacopoeia and according to the respective guidelines. For substances and products which are only available in very small quantities, we optionally offer the residual solvent testing using an in-house validated micro-determination.

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