Custom Synthesis and Radiolabeling
As part of the Eurofins Scientific Network, Eurofins Regulatory Science Services offers a full range of 14C custom radiolabeling services, the synthesis of unlabeled reference compounds, and other analytical chemistry services. With many years of experience, our team of expert synthetic radiochemists can prepare 14C labeled small molecules of almost any complexity for use in metabolism, dermal penetration, environmental fate, and other studies.
OECD and OCSPP-Compliant Radiolabelling Services: Radiolabeled compounds are routinely used to generate data required for registration of pesticides and other chemicals under guidelines published by the OECD and the OCSPP (EPA).
Our radiochemists combine detailed knowledge of the special aspects of radiochemistry with excellent synthetic strategy, robust design, and efficient execution to achieve timely and cost-effective results for our clients.
All of our products are delivered with a comprehensive analytical data package including full spectroscopic analysis and experimental documentation. A Certificate of Analysis specifying chemical as well as radiochemical purity by NMR, MS, radio-HPLC, and radio-TLC (where appropriate) accompanies each compound. Analyses can be GLP-certified, making them suitable for regulatory submission.
Our OECD and OCSPP-Compliant Radiolabeling services include:
- 14C Radiosynthesis including de novo development of synthetic routes
- Chiral separation and salt formation
- Rapid re-purification service
- Storage and management of radiolabeled compounds for clients
- Safe and fast shipment worldwide to multiple destinations if required
- Full Certificate of Analysis and analytical profile
- GLP certification, if required
GLP Analytical Chemistry Services and Metabolite Synthesis: Our analytical team has many years of experience supporting all kinds of regulatory studies, and exceptional instrumentation and infrastructure. Our analysts work closely with our synthetic chemists to solve the chemical structures of process impurities, metabolites, and/or degradation products and provide the solutions you are looking for. Our analytical department is accredited by the MHRA and certified by the UK’s Good Laboratory Practice (GLP) program. We specialize in GLP NMR to support regulatory submissions.
Our specialized analytical services are tailored to individual needs to support regulatory studies and submissions, and include the following capabilities:
- GLP NMR for structural confirmation and comparison with standards and full interpretation and structural elucidation
- GLP analysis including mass spectrometry and infrared spectroscopy
- Custom synthesis of metabolites, impurities and reference standards
- Custom synthesis of compounds labelled with stable isotopes such as Carbon-13, Nitrogen-15, and Deuterium*
- Non-routine analytical studies including structural elucidation and impurity profiling at microgram levels using capillary NMR
* All custom-prepared products are available with a GLP Certificate of Analysis
Contact erssinfo@eurofins.com for more information!
