Selcia has extensive expertise in radiolabelling small molecule drugs for drug metabolism, pre-clinical and pharmacokinetic studies. Our chemists have many years of experience working in big pharma and we provide overflow capacity to internal isotope groups and synthesise radiolabelled API using GMP concepts for mass balance and microdosing studies. Our analytical group has expertise in using high field NMR to identify impurities and to ensure the material is suitable for the intended study. We also have experience radiolabelling pharmaceuticals for environmental fate studies.
Industries
Pharmaceutical and Biotechnology Industry
Animal Health Industry
Selcia has extensive experience in radiolabelling compounds for total residue and environmental fate studies for regulatory submission. We use high field NMR and HPLC to ensure radiochemical and chemical purity of your radiolabelled compound. We can provide a GLP Certificate of Analysis if required.
Crop Protection and Biocides Industry
The Selcia radiolabelling team span out from Aventis CropScience and includes experts from Rhone-Poulenc and AgrEvo and the core analysts from RP's environmental fate group. Our outstanding GLP-accredited analytical group ensures the radiolabelled compound is suitable for regulatory studies. Our in-depth problem solving skills and many years of experience in insecticides, herbicides and fungicide chemistry are available for metabolite identification, impurity profiling and structural elucidation followed by synthesis of standards to support the CRO and your regulatory submission.
BIOCIDES: Specific guidance (EU 582/2012) | C-14 Custom Radiolabelling | Carbon-14 Radiolabelled API to GMP | Crop Science Expertise | Nature of the Radiolabelled Test Substance for Registration Studies | Partnership and Outsourcing | REACH European Chemicals Agency (ECHA) – Regulatory Guidance on use of Radiolabelled Compounds | Registration Studies Using 14C Radiolabelled Compounds | Techniques & Equipment
Personal Care, Flavours & Fragrances
Selcia has extensive experience in radiolabelling compounds for dermal penetration and environmental fate studies for regulatory submission. Selcia’s analytical expertise – particularly high field NMR – will ensure the radiolabelled material matches the structural identity of your material. We use high field NMR and HPLC to ensure radio and chemical purity of your radiolabelled compound, which can include a GLP Certificate of Analysis.
Chemicals
Selcia has extensive experience in radiolabelling compounds for dermal penetration and environmental fate studies for regulatory submission. We use high field NMR and HPLC to ensure radio and chemical purity of your radiolabelled compound, which can include a GLP Certificate of Analysis. Selcia’s experienced analytical group is always available to discuss follow up metabolite ID and impurity identification if required.
Food and Nutrition
We specialise in the synthesis of challenging molecules and in developing and implementing synthetic strategies to radiolabel complex natural products. Selcia has extensive experience in radiolabelling compounds for distribution studies. We use high field NMR and HPLC to ensure radio and chemical purity of your radiolabelled compound, which can include a GLP Certificate of Analysis.
Contract Research Organisations
We are experienced in working with the client and the contract research laboratory performing the study to ensure the radiolabelled compound arrives in time and to the required specification. We engage in effective and frequent communication with all parties concerned resulting in a coordinated approach and smooth delivery. Selcia will ship the radiolabel compound directly to the CRO laboratory performing the study. Each radiolabelled compound is accompanied by a comprehensive data package including a CoA and optional GLP certificate. Selcia’s experienced analytical group is always available to discuss metabolite and impurity identification if required.
BIOCIDES: Specific guidance (EU 582/2012) | C-14 Custom Radiolabelling | Carbon-14 Radiolabelled API to GMP | GLP Analytical Chemistry Services and Metabolite Synthesis | Nature of the Radiolabelled Test Substance for Registration Studies | Partnership and Outsourcing | REACH European Chemicals Agency (ECHA) – Regulatory Guidance on use of Radiolabelled Compounds | Registration Studies Using 14C Radiolabelled Compounds | Techniques & Equipment
REACH Services
Selcia has experience of working with REACH consortia and data submission to regulatory authorities. We have established many contacts with REACH consultants and attended various REACH conferences. Key services include substance identification, measurement and identification of impurities and compound differentiation between batches. In our MHRA-accredited GLP analytical laboratory equipped with GLP 500,400 & 300 MHz NMR we can ensure the best analytical techniques are employed to address your needs.
BIOCIDES: Specific guidance (EU 582/2012) | C-14 Custom Radiolabelling | GLP Analytical Chemistry Services and Metabolite Synthesis | Nature of the Radiolabelled Test Substance for Registration Studies | REACH European Chemicals Agency (ECHA) – Regulatory Guidance on use of Radiolabelled Compounds | Registration Studies Using 14C Radiolabelled Compounds | Techniques & Equipment