The rationale for selection of carbon-14 in the radiolabeling of drug substances lies in the ability to substitute particular carbon-12 atoms in a molecule by carbon-14 to produce chemically identical analogues.
Prior to synthesis, we identify an appropriate position of the radioactive label that is expected to be chemically and metabolically stable. Incorporation of carbon-14 into the target molecule requires the total synthesis from basic precursors such as 14C-cyanide.
Our synthetic expertise and application of the latest methods and techniques including enantioselective synthesis and chiral separation allows us to synthesize almost any achiral and chiral chemical compound. Typical batch sizes are in the range of 400 MBq, considered sufficient to execute entire preclinical DMPK programs. As needed we can provide higher amounts, often required for environmental safety studies.
All radiolabeled compounds are released with a comprehensive certificate of analysis (CoA) comprising chemical and radiochemical purity by HPLC, LC-MS, NMR, and radio-thin layer chromatography (TLC) analyses as well as enantiomeric purity (if applicable).