Analytics

F1 Pharma offers:

  • development of analytical procedures using chromatographic methods, spectrophotometric  methods and other techniques based on classical analysis for active substances and final drug products.
  • validation of analytical methods in accordance with ICH, FDA and EMA guidelines
  • analytical method transfer to target/client laboratory
  • rate of dissolution (dissolution profiles) of active substances from various drug forms
  • analysis of physicochemical properties for active substances (DSC, TGA, XRPD, SEM imaging, particle size distribution)
  • reological studies, texture analysis
  • compatibility studies for formulation components
  • determination of impurity profiles, characterization of impurities, identification of unknown impurities and degradation products
  • evaluation of analytical documentation in accordance with GMP and regulatory affairs requirements
  • consultancy in scope of analytical method development and preparation of documentation for registration purposes