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Aspen API. Analytical Development

Our Analytical Development laboratories, filled with state-of-the-art equipment, enables us to rapidly solve complex analytical challenges.

Our analytical laboratories are equipped with world class equipment, including a HRMS, several LC-MS(MS) systems, a variety of LC and GC systems and a 500 MHz NMR. Our highly skilled and enthusiastic team, who thrive on analytical challenges, has extensive years of relevant experience which can be used to benefit your needs.

Responsible for a variety of key activities

  • Analytical method development and subsequent validation/ verification and method transfer activities
  • Analytical activities in support of Regulatory and Quality compliance
  • Implementation of the Stability program and reference standard program
  • Implementation of the cleaning validation and continuous monitoring program
  • Laboratory equipment procurement, maintenance and compliance.

Structure elucidation and impurity characterization

One of the main applications of the available equipment is rapid structure elucidation, which is regularly applied during trouble shooting events. For example, the identification of unknown impurities can be extremely valuable for root cause finding and solving the problem for future batches.
The (LC-)HRMS is specifically valuable for these cases since it can determine the elemental composition of an impurity directly from small peak in the HPLC chromatogram (~0.1 a/a%). If this approach is unfeasible, or when more extensive knowledge on the impurity is required, we can isolate the unknown peak to enable structure determination with (2D)-NMR.

Low level quantification

The LC-MS equipment is also frequently used for low level quantification of small molecules. We routinely use tandem-MS analyses to enable detection limits at the low ppb range. In addition, we have applications for larger molecules such as proteins in qualitative or quantitative analyses

NMR release testing of API and intermediates

Besides offering support in trouble shooting, we also use our NMR system for release testing of API and intermediates. We specifically use this system for 1H-NMR, 13C-NMR and solid state NMR release testing.

Other equipment includes state of the art gas and liquid chromatography systems, Ion mobility Scan systems, Laser Particle Size Analysers and Thermogravimetric instruments.

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