Radiopharmaceuticals.
Radiopharmaceuticals are used in diagnostics and therapy. They require special authorizations and are used for precise imaging and targeted disease treatment. With our patented RADIOSTER® technology, we are the world leader in carrying out analyses of radioactive pharmaceuticals. We offer immediate testing without loss of time due to decay.
Our patented
RADIOSTER®.
Our laboratories are GMP-certified, FDA-inspected and are licensed to handle high doses of radioactivity for common radionuclides such as Lu-177, I-131, Zr-89, Y-90, I-123, F-18, Ga-68 and more.
We also offer:
- Analysis of precursors for radiopharmaceuticals (e.g. peptides).
- Determination of assay and impurities.
- Determination of residual solvents.
- Analysis of elemental impurities.
Our Specialities
in this area:
Sterility testing (radioactive).
Are you looking for reliable, precise and timely
sterility tests for your products?
Sterility is crucial to ensure the safety and efficacy of your injectables and radioactive pharmaceuticals.
We perform sterility testing using two main monographed methods according to Ph.Eur. 2.6.1 and USP <71>:
- Membrane filtration: The product is filtered through a special membrane that retains microorganisms. The membrane is then cultivated within a nutrient media to detect microorganisms.
- Direct inoculation: This method introduces the product directly into culture media. It monitors whether microorganisms are growing.
- Handling of high doses of radioactivity: We are able to accept and safely handle high doses of radioactivity.
- Patent-protected processes: We work with unique technologies for your safety and efficiency. Both our membrane filtration method and the use of our isolator are patented.