Services

HPLC / Mass Spectrometry

We have three qualified HPLC units ready to engage for your GLP, GCP and GMP projects, as well as in your research projects (non-regulated area).

  • Two LC-MS-MS devices are each equipped with a tandem mass spectrometer (triple quadrupole system). These are used to determine pharmacokinetic and toxicokinetic parameters and can also identify any impurity.
    Our equipments allow us a throughput of around 50,000 specimens a year.
  • We use our HPLC-UV unit for content and impurity analyses as well.

We develop and validate HPLC and LC-MS-MS methods for your substances in accordance with current guidelines (FDA, EMA, ICHQ2R) while taking your individual requirements into account. Our years of experience in handling different biofluids (plasma, serum, urine, etc.) and non-biological matrices are of direct benefit to your project.

Methods

  • HPLC-UV
  • LC-MS-MS

Applications

  • Small molecule quantification
  • Large molecule quantification
  • GLP and GCP analysis for:
  • Pharmacokinetics
  • Toxicokinetics
  • Preclinical trials in conventional animal models (monkey, rat, mouse, dog)
  • Phase I-III clinical trials
  • ECOTOX studies
  • Supporting analyses for drug approval under GMP:
  • Content determination of raw materials and finished products
  • Impurity measurements

Contact

If you would like to start talking about how we can help you, or if you’re still not sure if we can address your needs and you have questions, don’t hesitate to get in touch with us.