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Isotope labelling

Isotope labelling services

Radiolabelling is a cornerstone technique in drug metabolism and pharmacokinetics (DMPK) studies for tracking a drug’s journey through the body, providing essential data to inform critical decisions during drug development. For over 50 years, Nuvisan has specialised in radiolabelling of NCEs (³H, ¹⁴C) and synthesis of stable isotope-labelled NCEs (²H, ¹³C, ¹⁵N). Our expertise and state-of-the-art capabilities enable precise, high-quality results, helping accelerate your research and development process with tailored solutions for even the most complex requirements.
Lab vial with glowing liquid submerged in liquid nitrogen, featuring a prominent radioactivity symbol on its surface.

Stable isotope synthesis (2H, 13C, 15N)

Stable isotope-labelled compounds are used as internal standards in bioanalysis to control for extraction, ionisation and injection variability, making them essential for robust mass spectrometric analysis. We have successfully delivered stable isotope-labelled molecules from a diverse spectrum of compound classes, including small molecules, peptides, carbohydrates, lipids and more.

Radioactive isotope synthesis (14C)

The rationale for selecting carbon-14 in the radiolabelling of compounds lies in its ability to substitute specific carbon-12 atoms, producing chemically identical analogues. Before synthesis, we identify an appropriate position for the radioactive label that is expected to be chemically and metabolically stable. Incorporating carbon-14 into the target molecule requires total synthesis from basic precursors such as 14C-cyanide. By applying the latest methods and techniques, including enantioselective synthesis and chiral separation, we can synthesise almost any achiral or chiral chemical compound. All radiolabelled compounds are released with a comprehensive certificate of analysis (CoA), detailing chemical and radiochemical purity, as well as enantiomeric purity (if applicable).

Radioanalytical and purification services

We analyse your radiolabelled compound using state-of-the-art methods and equipment to assess radiochemical purity, specific activity and stability. Employing high-efficiency separation techniques, we purify radiolabelled compounds to remove impurities and by-products, helping ensure the highest quality material for your experiments and studies.

Compound storage solutions

Nuvisan provides safe storage of radiolabelled material at various temperatures in a controlled and monitored environment. Worldwide shipment is arranged by personnel trained in Good Distribution Practices (GDP) using qualified couriers. Reanalysis and repurification can be performed on short notice before shipment or use in our (in-house) studies to help meet project timelines.

Frequently asked questions (FAQs)

  • What is radiolabelling and why is it required for animal and human ADME mass balance studies?
    Radiolabelling involves incorporating a measurable radioactive isotope into a drug molecule, most commonly carbon-14 or tritium. The radiolabel allows investigators to track the absorption, distribution, metabolism and excretion of the compound and its metabolites. 

    These studies are essential in ADME and mass balance work because they provide a quantitative way to recover and account for total drug-related material, including metabolites that may be difficult to detect using non-radiometric methods alone. 
  • Does Nuvisan offer carbon-14 and tritium radiolabelling services for ADME and mass balance studies?
    Yes. Nuvisan provides isotope chemistry support for ADME and mass balance studies, including carbon-14 and tritium radiolabelling. We also support the synthesis of deuterated, carbon-13 and nitrogen-15 labelled compounds for use as internal standards, absolute bioavailability tracers and mechanistic research tools.
  • When do I need a radiolabelled compound in my drug development program?

    Planning for radiolabel synthesis should start early, ideally before candidate selection. Synthesising a radiolabelled compound can take several months, and lead times may affect the timing of preclinical and clinical ADME work. 

    Radiolabelled compounds are typically required for: 

    • preclinical mass balance and tissue distribution studies 
    • quantitative whole-body autoradiography 
    • clinical ADME studies 
    • human absolute bioavailability studies 
    • metabolite profiling where total drug-related material must be tracked. 
  • When is tritium labelling used instead of carbon-14 in ADME studies?
    Tritium labelling may be used where high specific activity is required, where synthesis with carbon-14 is not feasible or where a faster route to labelled material is needed. However, tritium can exchange under some conditions, so the choice between tritium and carbon-14 depends on the compound structure, study objective and required data quality.

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Neu-Ulm (headquarters)

Wegenerstrasse 13

89231 Neu-Ulm

Germany

Berlin

Muellerstrasse 178

13353 Berlin

Germany

Sophia Antipolis

2400 route des Colles

06410 Biot

France

Grafing

Am Feld 32

85567 Grafing

Germany

Waltrop

Im Wirrigen 25

45731 Waltrop

Germany

For concerns about pharmaceuticals or adverse drug-related events, contact us at: complaints@nuvisan.com
 
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