Customized radiosynthesis of a chemical allows the assessment of its metabolism, degradation and final fate in animals, humans and the environment. This information is vital for many safety assessment endpoints for chemicals.
Radiosynthesis involves producing an analogue of a test substance by replacing one or more atoms with a radioisotope. In most cases, 14C is the radioisotope incorporated into the test substance, although other isotopes may be needed for some chemicals not containing carbon. The exact positioning of the 14C atom is critical to allow you to follow the fate of the entire molecule and all metabolites and degradation products. In some instances, multiple radiolabeled substances are produced, with labels at different positions, to ensure that the entire biotransformation of the substance is tracked.
- A dedicated team of chemists with extensive expertise in bespoke synthesis design, leading to high purity radiolabeled substances via chemical synthetic routes
- Proven track record for successful synthesis and purification of radiolabeled compounds
- Flexible facilities allow us to leverage capacity to meet your needs
You need a high-purity, well-characterized radiolabeled test substance designed to meet your endpoints
Many safety assessment studies need a radiolabeled test substance, but how do you ensure you have the right test substance that will meet the target endpoints? You need to consider a range of things: How best to label your substance – will 14C be appropriate? What’s the best positions for labeling that will guarantee you can track all metabolites and degradation products? What's the approach if the substance is a mixture? How pure is your radiolabeled test substance and can you properly identify it? What quantity of substance do you need and how can you minimize expense? Have you got appropriate reference materials for the studies?
High-quality radiosynthesis that delivers safety assessment success
Our dedicated in-house team of radiochemists have extensive expertise in the radiosynthesis and purification of test substances for chemical safety assessment. By working collaboratively with metabolism scientists, we ensure that the radiosynthesis strategy reflects the needs driven by safety assessments endpoints. It also means we can optimize production to ensure efficiency and cost effectiveness.
As well as in-house radiosynthesis of test substances, we have strong links with other commercial suppliers. This allows us to offer managed procurement of radiochemicals (where we cannot produce these in-house) and assist in the sourcing of non-radiolabeled reference compounds or stable labeled analogues.
Detailed analytical data dossier to support your verified radiolabeled test substance
All synthesized products undergo analytical characterization for radiochemical purity and identify. The following checks are standard, resulting in a final certification of analysis:
- Radiochemical purity ≥95% (or as specified) confirmed using HPLC and/or TLC
- Chemical identity by co-chromatography with authentic reference compound
- Chemical identity by mass spectrometry
- Specific activity by mass spectrometry, HPLC-UV or gravimetric analysis
- Certificate of Analysis (QC and peer reviewed)
Comprehensive radiosynthesis facilities
We have four dedicated laboratories for radiosynthesis and purification equipped with a comprehensive range of analytical tools, including access to Reaxys database search system for synthesis literature.