Extractables and leachables studies of a radionuclide generator
Institut National des radioéléments
29/03/2024
Section I: Contracting authority
Institut National des radioéléments
Avenue de l’Espérance 1, 6220 Fleurus, Belgium
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Section II: Object
aeb47b88-198c-446b-94d8-96e8f46114e6
F02
Extractables and leachables studies of a radionuclide generator
IRE ELiT is one of the only two global suppliers of germanium-68 (68Ge) / gallium-68 (68Ga) generators approved as a drug in Europe and as an Active Pharmaceutical Ingredient in the United States. More information about IRE Elit germanium-68 (68Ge) / gallium-68 (68Ga) radionuclide generator product characteristics can be found on: https://www.ire.eu/medias/295/UK.pdf. Substances that migrate from a container closure system (CCS) into a drug product formulation can potentially affect its safety, stability and efficacy. Therefore, as part of regulatory compliance, the generator CCS must be assessed for extractables and leachables. Both extractable and leachable reference studies exist for the IRE Elit generator. This procurement notice concerns complementary studies.
IRE ELiT is one of the only two global suppliers of germanium-68 (68Ge) / gallium-68 (68Ga) generators approved as a drug in Europe and as an Active Pharmaceutical Ingredient in the United States. More information about IRE Elit germanium-68 (68Ge) / gallium-68 (68Ga) radionuclide generator product characteristics can be found on:
https://www.ire.eu/medias/295/UK.pdf.
Substances that migrate from a container closure system (CCS) into a drug product formulation can potentially affect its safety, stability and efficacy. Therefore, as part of regulatory compliance, the generator CCS must be assessed for extractables and leachables. Both extractable and leachable reference studies exist for the IRE Elit generator. This procurement notice concerns complementary studies.
UNKNOWN
(quality) : Qualité de la méthodologie Quality of the methodology
(quality) : qualité de l’équipes quality of the teams
(price) : Prix Price
BE32B
BEL
Voy. cahier des charges See specifications
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