We offer the possibility to analyze the profile of impurities in active substances (API), impurities in pharmaceutical products/ biopharmaceuticals and those resulting from the processes of degradation.
We also carry out tests within the scope of detection, identification and quantification of impurities in accordance with the requirements of the pharmacopoeial monographs (USP, Ph. Eur., FP), recommendations of the International Conference on Harmonization (ICH), the requirements of the European Medicines Agency (EMA) as well as the American Food and Drug Administration (FDA).
Our research is carried out on the basis of procedures recommended by the customer. We also offer the development and validation of methods enabling assessment of the profile of impurities for innovative pharmaceuticals and biopharmaceuticals as well as assistance in preparing registration documentation in accordance with the ICH, EMA and the FDA guidelines.
Our tests are carried out with the use of highly advanced equipment based on the wide spectrum of separation techniques, isolation and identification of impurities: HPLC (on analytical, preparative and semi-preparative columns), UPLC, SEC, IEC, LC-MS, LC-MS/MS, MALDI-TOF, MALDI-TOF/TOF, GC, GC/MS, CE, IR, NIR, FTIR, UV-VIS, polarimetry.