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Isotopic Labelling

ARCINOVA prepare Carbon-14 labelled materials for both non-clinical and clinical studies. For clinical trial support, we have the capability to prepare GMP compliant radiolabelled material in a dedicated laboratory. 

Additional Experience and Services:

  • Ability to safely handle high potency / high hazard compounds (cytotoxics)
  • Synthesis of metabolites & reference materials aiding Bioanalytical and Metabolism studies
  • Degradants and process impurities to support API development,
  • GTI assessment of confirmed impurity / degradant structures found during the scientific evaluation of investigational drug substances and products, to comply with ICH M7 guidance.
  • Route development and precursor synthesis for labelling with 3H and short lived isotopes 11C and 18F
  • Access toExperienced in classical and non-classical synthetic techniques, microwaves, H/D-cubes, automated peptide synthesis, microbiological and bio-catalysis.

 

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