PROMPT STERILITY TESTING OF RADIOPHARMACEUTICALS

WE ANALYZE YOUR RADIOACTIVE PHARMACEUTICALS

RADIOSTER is a CUP Laboratorien subsidiary which is tailored to the need of the radiopharmaceutical industry with highly experienced scientists. Our laboratories are FDA-inspected and cGMP-certified and have the permission to handle high doses of radioactivity.

 

Our services

  • Radioactive sterility testing according to USP <71> and EP 2.6.1
  • We can handle radionuclides such as Lu-177, I-131, Zr-89, Y-90, I-123, F-18, Ga-68
  • Save and fast transport
  • Fast development and validation of analytical methods according to ICH-Guide lines

We offer in addition

  • Analysis of chemical precursors
  • Assay and impurities and rapid method devolpment and validation
  • Determination of residual solvents
  • Analysis of elemental and heavy metal impurities

The construction project is co-financed by tax revenue on the basis of the budget decided by the Saxon state parliament.