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 for Radiopharmaceuticals
& product specific Validation.
Fast. Safe. GMP and FDA compliant.
We are the specialist and ensure your sterility tests are regulatory-proof, even with short half-lives, high radioactivity doses, and complex formulations.
The FDA requires that microbiological methods are demonstrated to be suitable for each product before routine use (product-specific suitability testing).
For radiopharmaceuticals, this is essential because:
- Radioactivity can inhibit microbial growth,
- Short shelf lives demand special test strategies,
- Complex carrier solutions can impact test results.
Our experts tailor each test precisely to your product – ensuring maximum safety and regulatory compliance.
Two established Methods – Ph.Eur. 2.6.1 & USP <71>:
- Membrane Filtration – Filtering the product through a microbe-retaining membrane, followed by incubation in growth media.
- Direct Inoculation – Directly adding the product into growth media and monitoring for microbial growth.
Both methods are validated for each specific product – even under radiopharmaceutical conditions.