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SERVICES » Pharma Svcs » Syn

Non-CGMP Radiolabeling

Radiolabeling demands extensive training, experience, and an understanding of where on a molecule a label should be introduced to optimize stability and cost-efficiency. ABC Laboratories maintains a staff of talented, Ph.D.-level radiosynthetic chemists who are known for their ability to introduce radioactive and stable isotope labels at positions optimal for supporting in-vitro and in-vivo DMPK studies.

Our synthesis group supports our DMPK/Bioanalytical and CGMP analytical groups with research-grade and GLP materials—including APIs, internal and reference standards, intermediates and other materials used for impurity and metabolite identification.

Preclinical Support

  • Radiolabled (14C) API for in-vivo and in-vitro studies
  • API (tox lot) suitable for preclinical GLP studies
  • Reference standard synthesis and qualification
  • Stable-labeled API/metabolites (13C or 2H) for use as internal standard
  • Impurity identification, isolation, synthesis and characterization
  • Analytical support dedicated to synthesis activities
Radiolabeling Synthesis

ABC Laboratories' experience with more rigorous CGMP requirements enables us to quickly and economically deliver radiolabeled compounds for non-regulated studies.