Development and validation of analytical methods

The development and validation of analytical methods is laborious and expensive. Using sophisticated analytical equipment, we are able to develop reliable analytical methods which, after development, can be validated. We will work in close consultation with you to determine the necessary and sufficient extent of validation. The European guideline ICH Q2(R1) (CPMP/ICH/381/95 and CPMP/ICH/281/95: Terms and Methodology) and the demands of our customers are used as the basis of our services.

Depending on the analytical task and the scope of the method, the following validation parameters are examined:

  • Linearity
  • Precision, Reproducibility (intermediate precision)
  • Accuracy
  • Specificity and selectivity
  • Robustness
  • Limit of detection and quantification

Our validation report contains comprehensive statistical data. For data evaluation and calculation of the statistical characteristics, we use the most recent version of the validated software VALIDAT (iCD. GmbH).
We will gladly consider any detailed requests concerning the content and structure of a validation plan and  report.