Skip to content

Publication: ICH Q14-inspired novel approach

Chromicent’s latest publication is a case study inspired by the ICH Q14 guideline on method development under analytical quality by design (AqbD) principles using the example of carbamazepine.

The ICH-Q14 guideline has recently become internationally valid and implements the requirements and specifications of ICH-Q8 for laboratory operations.

Following systematic development and validation, the SFC method for carbamazepine presented in the publication proves to be an alternative to the official HPLC method published in the European Pharmacopoeia. Noteworthy are the improved peak resolution, the improved peak symmetry and the faster analysis times (3 min compared to 80 min with the official method).

We are pleased to present our publication “ICH Q14-inspired novel approach to establish an SFC-based purity method for carbamazepine”, published in Drug Testing and Analysis, ahead of our established event: ICH Q14 –Development of analytical methods