HZDR is holding marketing authorizations for following PET radiopharmaceuticals
- [18F]FDG ([18F]fluoro-2-deoxy-D-glucose) - GlucoRos© since 2005
[approval No. 63584.00.00] - [18F]Sodium fluoride for injection - NaFRos© since 2012
[approval No. 79232.00.00] - [18F]FDOPA (3,4-dihydroxy-6-18F-fluoro-L-phenylalanine) – DOPARos© since 2017
[approval No 87703.00.00]
Disposal and shipment of GlucoRos©, NaFRos© and DOPARos© is performed by our partner ROTOP Pharmaka GmbH.
The following PET radiopharmaceuticals were produced in frame of our manufacturing license for in house application
- [11C]Methionin (for investigation of brain tumors and amino acid transporters)
- [18F]FMISO ([18F]Fluoromisonidazole for evaluation of tumor hypoxia)
- [18F]PSMA-1007 (a new radiotracer for prostate cancer imaging)
Additionally, HZDR is approved by GE Healthcare as manufacturing facility of
- [18F]Flutemetamol (Vizamyl©), a radiotracer used for estimation of ß-amyloid neuritic plaque density in human brain.
Further PET radiopharmaceuticals and radioisotopes can be provided for pre-clinical research on request
- [18F]FLT ([18F]fluorothymidine)
- [18F]FET ([18F]fluoroethyltyrosine)
- [18F]Fluoride for radiolabelling
- [64Cu]Cu for radiolabelling
Quality control
Each single batch of our produced radiopharmaceuticals is daily analyzed by quality control for the following parameters before release for clinical application:
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[HPLC, half-life, γ-spectrometry] | |
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[radio-HPLC, radio-TLC] | |
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(by-products /starting materials) | [HPLC, TLC] |
(residual solvents) | [GC/MS] | |
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[half-life, γ-spectrometry] | |
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[pH-meter] | |
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[Osmometer] | |
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(bacterial endotoxins) | [LAL test] |
(sterility) | [sterile test for sample A and B] | |
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[particle, microbiology, humidity, temperature] | |
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[personnel, rooms, equipment] |